A Phase 2 interventional study of Bococizumab (PF-04950615;RN316) and Bococizumab (PF-04950615;RN316) in Hypercholesterolemia, sponsored by Pfizer. Completed at 9 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-02-08.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C) lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled.
1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.
This study's enrollment of 218 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A total of 9 groups in two population. Population A comprises hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin. A subject who is receiving a stable dose of atorvastatin will be randomized into one out of 5 dose groups.
Drug: Bococizumab (PF-04950615;RN316) · Drug: Placebo · Drug: Ezetimibe
A total of 9 groups in two population. Population B comprises hypercholesterolemic Japanese subjects who are naïve for a treatment by lipid lowering drug and whose fasting LDL-cholesterol is not controlled. A subject who is treatment naïve will be randomized into one out of 4 dose groups.
Drug: Bococizumab (PF-04950615;RN316) · Drug: Placebo
Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week
Atorvastatin plus PF-04950615 100 mg Q14D SC for 16 week
Atorvastatin plus PF-04950615 150 mg Q14D SC for 16 week
Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week
Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open)
50 mg Q14D SC for 16 week
100 mg Q14D SC for 16 week
150 mg Q14D SC for 16 week
Placebo Q14D SC for 16 week
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Time frame: Baseline, Day 85
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 113
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Time frame: Baseline, Day 113
Low Density Lipoprotein-Cholesterol (LDL-C)
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 and Day 113
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time frame: Baseline, Day 85, 113
Total Cholesterol (TC)
Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113
Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113
Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Time frame: Baseline, Day 85, 113
Apolipoprotein B (ApoB)
ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113
ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113
ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Time frame: Baseline, Day 85, 113
Apolipoprotein A-I (ApoA-I)
ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113
ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113
ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Time frame: Baseline, Day 85, 113
Apolipoprotein A-II (ApoA-II)
ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113
ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113
ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Time frame: Baseline, Day 85, 113
Lipoprotein (a) (Lp[a])
Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113
Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113
Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Time frame: Baseline, Day 85, 113
High Density Lipoprotein- Cholesterol (HDL-C)
HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113
HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113
HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Time frame: Baseline, Day 85, 113
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113
VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113
VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Time frame: Baseline, Day 85, 113
Triglyceride (TG)
Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Triglyceride (TG) at Day 85 and Day 113
Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Triglyceride (TG) at Day 85 and Day 113
Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Time frame: Baseline, Day 85, 113
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113
Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113
Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Time frame: Baseline, Day 85, 113
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Time frame: Baseline, Day 85, 113
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
Time frame: Baseline, Day 85, 113
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 10, 25, 40, 70 and 100 Milligram Per Deciliter
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection.
Time frame: Baseline up to Day 113
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 169 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included treatment emergent injection site adverse events and any clinically significant abnormal laboratory value.
Time frame: Baseline up to Day 169
Number of Participants With Anti-Drug Antibody (ADA) Response
Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level \>=6.23 for PF-04950615 were considered ADA positive.
Time frame: Baseline up to Day 169
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615
Area under the plasma concentration time-curve from time zero to end of dosing interval (tau). This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time frame: Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-04950615
Area under the plasma concentration-time profile from time zero extrapolated to infinite time. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time frame: Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time frame: Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Maximum Observed Plasma Concentration (Cmax) of PF-04950615
This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time frame: Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hr post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Minimum Observed Plasma Trough Concentration (Cmin) of PF-04950615
This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time frame: Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615
This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time frame: Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Terminal Elimination Half-Life (t1/2) of PF-04950615
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time frame: Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =6.99 nanogram per milliliter \[ng/mL\]) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Time frame: Day 1, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141
| Milestone | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Started | 25 | 24 | 24 | 26 | 22 | 25 | 25 | 24 | 23 |
| Completed | 25 | 24 | 23 | 25 | 22 | 24 | 23 | 24 | 23 |
| Not completed | 0 | 0 | 1 | 1 | 0 | 1 | 2 | 0 | 0 |
| Withdrew: Other | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Does not meet entrance criteria | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
| percent change | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 | -55.65 ± 15.748 | -68.25 ± 18.769 | -74.00 ± 13.848 | -5.91 ± 14.323 | -18.56 ± 15.968 | -47.25 ± 17.699 | -62.24 ± 16.097 | -65.89 ± 10.779 | -1.21 ± 14.815 |
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
| percent change | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 113 | -54.41 ± 12.062 | -64.46 ± 19.149 | -69.98 ± 19.074 | -12.10 ± 12.727 | -20.55 ± 18.682 | -44.94 ± 19.641 | -61.79 ± 15.476 | -66.98 ± 12.396 | 0.39 ± 16.246 |
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 135.36 ± 23.652 | 123.85 ± 20.585 | 129.19 ± 17.769 | 135.90 ± 24.697 | 135.36 ± 24.745 | 164.22 ± 25.839 | 158.00 ± 20.004 | 159.90 ± 19.800 | 155.22 ± 23.096 |
| Day 5 | 86.72 ± 24.917 | 71.83 ± 26.020 | 76.04 ± 17.111 | 130.35 ± 22.280 | 111.50 ± 23.118 | 128.68 ± 30.905 | 120.20 ± 21.352 | 114.63 ± 30.177 | 165.09 ± 22.880 |
| Day 8 | 70.36 ± 18.932 | 55.38 ± 28.309 | 57.71 ± 16.433 | 132.08 ± 21.244 | 105.86 ± 21.070 | 118.20 ± 33.823 | 102.63 ± 26.577 | 96.50 ± 36.130 | 167.22 ± 23.537 |
| Day 15 | 73.76 ± 18.807 | 51.96 ± 23.921 | 39.00 ± 16.395 | 132.50 ± 19.449 | 102.64 ± 19.458 | 113.28 ± 36.371 | 80.44 ± 25.366 | 77.08 ± 25.943 | 165.39 ± 21.148 |
| Day 22 | 49.08 ± 19.577 | 37.58 ± 20.011 | 31.00 ± 11.176 | 133.27 ± 19.359 | 101.68 ± 21.825 | 90.32 ± 34.956 | 67.29 ± 26.527 | 67.71 ± 32.399 | 166.04 ± 15.741 |
| Day 29 | 61.56 ± 24.316 | 48.29 ± 21.814 | 34.26 ± 13.965 | 129.60 ± 23.381 | 107.50 ± 23.299 | 93.36 ± 36.718 | 65.20 ± 17.970 | 63.58 ± 23.404 | 168.14 ± 24.032 |
| Day 36 | 44.40 ± 19.967 | 35.13 ± 17.306 | 29.52 ± 11.233 | 128.50 ± 23.930 | 103.05 ± 26.462 | 80.64 ± 34.744 | 60.67 ± 19.257 | 60.75 ± 27.619 | 154.00 ± 22.815 |
| Day 43 | 58.24 ± 21.357 | 39.63 ± 20.342 | 31.83 ± 11.750 | 126.23 ± 14.356 | 104.95 ± 23.941 | 87.76 ± 36.555 | 64.84 ± 19.882 | 61.83 ± 29.732 | 167.30 ± 21.850 |
| Day 50 | 39.76 ± 16.042 | 32.33 ± 16.578 | 29.96 ± 11.400 | 127.92 ± 20.392 | 106.23 ± 21.728 | 76.96 ± 32.194 | 57.91 ± 20.889 | 59.29 ± 28.406 | 158.83 ± 17.031 |
| Day 57 | 56.88 ± 18.306 | 37.21 ± 18.352 | 29.61 ± 11.053 | 125.27 ± 20.330 | 99.27 ± 26.705 | 81.32 ± 33.628 | 63.54 ± 25.072 | 55.75 ± 26.272 | 152.91 ± 15.395 |
| Day 71 | 61.50 ± 22.683 | 36.29 ± 18.196 | 33.13 ± 13.384 | 130.31 ± 21.031 | 109.18 ± 26.412 | 90.96 ± 34.188 | 60.63 ± 24.315 | 57.33 ± 25.237 | 156.70 ± 25.663 |
| Day 85 | 58.96 ± 19.650 | 38.00 ± 19.077 | 33.91 ± 19.400 | 126.38 ± 21.478 | 110.64 ± 33.530 | 86.64 ± 30.447 | 59.83 ± 27.495 | 54.71 ± 18.388 | 151.30 ± 21.137 |
| Day 99 | 66.48 ± 23.208 | 41.96 ± 18.995 | 38.09 ± 25.183 | 125.80 ± 15.992 | 106.14 ± 31.001 | 93.80 ± 29.672 | 61.67 ± 31.175 | 54.25 ± 20.339 | 163.70 ± 17.778 |
| Day 106 | 45.16 ± 20.874 | 32.13 ± 18.059 | 37.36 ± 24.849 | 127.76 ± 17.973 | 104.14 ± 25.496 | 84.52 ± 29.679 | 57.00 ± 25.719 | 57.42 ± 22.654 | 155.57 ± 17.010 |
| Day 113 | 62.17 ± 20.417 | 42.88 ± 19.427 | 38.48 ± 24.346 | 118.88 ± 22.883 | 107.32 ± 30.459 | 89.44 ± 29.798 | 61.48 ± 28.511 | 53.39 ± 20.954 | 153.30 ± 16.255 |
| Day 127 | 108.16 ± 21.893 | 86.71 ± 27.414 | 61.87 ± 33.267 | 131.92 ± 21.922 | 132.73 ± 29.660 | 137.00 ± 36.894 | 87.22 ± 42.031 | 78.96 ± 25.696 | 161.17 ± 24.383 |
| Day 141 | 126.13 ± 26.555 | 111.38 ± 24.588 | 95.30 ± 37.497 | 129.32 ± 20.860 | 139.14 ± 38.095 | 160.80 ± 37.487 | 130.22 ± 40.707 | 103.08 ± 34.759 | 163.52 ± 22.224 |
| Day 155 | 126.52 ± 23.631 | 113.75 ± 19.236 | 110.57 ± 26.678 | 133.92 ± 23.240 | 139.45 ± 35.880 | 165.17 ± 31.251 | 140.78 ± 29.645 | 119.54 ± 32.896 | 158.17 ± 15.135 |
| Day 169 | 131.28 ± 25.988 | 123.42 ± 25.782 | 124.04 ± 24.453 | 129.28 ± 24.576 | 140.91 ± 39.309 | 168.50 ± 28.657 | 154.52 ± 21.715 | 137.13 ± 32.817 | 168.55 ± 19.767 |
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -76.40 ± 26.447 | -85.85 ± 28.977 | -95.11 ± 21.145 | -9.52 ± 21.041 | -24.73 ± 23.125 | -77.58 ± 29.943 | -99.28 ± 32.550 | -105.19 ± 19.833 | -3.91 ± 23.632 |
| Change at Day 113 | -73.33 ± 18.047 | -80.98 ± 28.902 | -90.54 ± 28.496 | -17.48 ± 20.767 | -28.05 ± 23.663 | -74.78 ± 34.970 | -97.63 ± 25.545 | -107.57 ± 21.765 | -1.91 ± 20.147 |
Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 214.16 ± 30.658 | 210.29 ± 21.594 | 211.71 ± 23.065 | 222.44 ± 31.317 | 222.84 ± 25.395 | 245.94 ± 30.425 | 243.26 ± 21.967 | 244.19 ± 29.987 | 242.04 ± 22.956 |
| Day 5 | 169.20 ± 28.586 | 154.83 ± 30.045 | 156.91 ± 22.240 | 219.42 ± 24.861 | 197.77 ± 25.487 | 211.56 ± 37.176 | 203.56 ± 28.777 | 199.58 ± 41.618 | 249.09 ± 24.156 |
| Day 8 | 149.72 ± 24.979 | 137.71 ± 31.992 | 136.50 ± 21.364 | 222.68 ± 28.253 | 190.19 ± 20.856 | 202.44 ± 37.095 | 184.58 ± 30.935 | 186.73 ± 44.905 | 254.26 ± 22.481 |
| Day 15 | 154.20 ± 26.011 | 137.83 ± 27.241 | 120.75 ± 25.589 | 221.69 ± 23.988 | 190.50 ± 20.964 | 198.64 ± 39.145 | 165.48 ± 30.456 | 165.71 ± 37.735 | 251.91 ± 24.830 |
| Day 22 | 129.28 ± 22.856 | 119.00 ± 26.462 | 112.78 ± 19.247 | 218.12 ± 24.006 | 190.64 ± 23.768 | 176.28 ± 36.510 | 152.63 ± 29.854 | 153.67 ± 43.213 | 253.57 ± 15.716 |
| Day 29 | 141.04 ± 27.355 | 133.54 ± 25.507 | 114.91 ± 24.487 | 217.12 ± 24.280 | 192.41 ± 31.173 | 176.36 ± 41.260 | 153.20 ± 25.762 | 150.42 ± 34.557 | 256.73 ± 22.391 |
| Day 36 | 124.12 ± 22.380 | 113.88 ± 25.000 | 107.35 ± 19.590 | 217.08 ± 26.204 | 187.55 ± 30.803 | 163.48 ± 39.528 | 147.08 ± 25.568 | 144.63 ± 40.577 | 244.65 ± 24.356 |
| Day 43 | 139.40 ± 23.944 | 128.83 ± 30.724 | 113.75 ± 23.167 | 214.62 ± 19.179 | 190.86 ± 28.734 | 171.96 ± 40.287 | 151.80 ± 23.638 | 147.25 ± 41.429 | 254.04 ± 19.793 |
| Day 50 | 120.04 ± 20.687 | 112.63 ± 23.585 | 107.74 ± 22.471 | 215.42 ± 23.262 | 189.18 ± 24.209 | 161.00 ± 37.653 | 145.22 ± 24.814 | 144.17 ± 40.223 | 246.09 ± 17.776 |
| Day 57 | 134.16 ± 25.826 | 116.96 ± 24.489 | 104.61 ± 20.045 | 208.04 ± 23.282 | 184.14 ± 31.148 | 158.96 ± 39.046 | 148.00 ± 30.107 | 135.83 ± 39.794 | 236.78 ± 16.105 |
| Day 71 | 142.13 ± 29.489 | 121.04 ± 28.608 | 113.48 ± 25.056 | 218.38 ± 23.474 | 192.91 ± 31.288 | 174.64 ± 37.758 | 146.17 ± 29.736 | 142.42 ± 37.326 | 243.74 ± 24.849 |
| Day 85 | 135.52 ± 25.161 | 119.58 ± 24.959 | 109.57 ± 27.611 | 208.88 ± 24.747 | 198.82 ± 36.000 | 165.44 ± 32.651 | 141.09 ± 31.318 | 134.17 ± 30.972 | 231.52 ± 22.701 |
| Day 99 | 151.24 ± 31.139 | 128.58 ± 28.864 | 122.36 ± 36.702 | 216.28 ± 19.250 | 194.05 ± 33.230 | 178.36 ± 33.103 | 149.83 ± 33.780 | 139.13 ± 32.510 | 249.83 ± 19.277 |
| Day 106 | 126.40 ± 29.017 | 114.75 ± 26.967 | 118.55 ± 29.987 | 212.36 ± 22.002 | 190.27 ± 28.352 | 167.84 ± 32.859 | 142.26 ± 32.265 | 139.92 ± 35.003 | 241.65 ± 18.982 |
| Day 113 | 140.63 ± 26.650 | 124.58 ± 27.910 | 115.17 ± 30.293 | 201.64 ± 26.967 | 191.73 ± 34.189 | 169.72 ± 31.052 | 146.00 ± 33.889 | 134.17 ± 31.400 | 236.83 ± 16.808 |
| Day 127 | 193.96 ± 26.253 | 176.88 ± 32.328 | 147.87 ± 37.486 | 219.32 ± 26.684 | 221.18 ± 32.444 | 223.16 ± 39.032 | 176.74 ± 46.917 | 166.63 ± 34.144 | 249.78 ± 25.598 |
| Day 141 | 209.75 ± 32.446 | 202.71 ± 26.989 | 184.09 ± 38.141 | 216.48 ± 22.450 | 229.50 ± 38.480 | 247.36 ± 40.025 | 217.43 ± 43.351 | 192.96 ± 37.406 | 253.48 ± 21.494 |
| Day 155 | 208.32 ± 28.912 | 203.83 ± 24.533 | 195.26 ± 31.865 | 221.28 ± 24.455 | 228.86 ± 37.640 | 250.00 ± 34.453 | 227.83 ± 31.438 | 208.25 ± 33.069 | 246.35 ± 15.171 |
| Day 169 | 212.96 ± 29.508 | 212.79 ± 25.267 | 211.00 ± 31.348 | 221.00 ± 26.091 | 234.95 ± 43.216 | 254.17 ± 32.859 | 245.57 ± 34.103 | 227.65 ± 39.088 | 258.64 ± 20.537 |
Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -78.64 ± 28.525 | -90.71 ± 31.705 | -101.43 ± 25.436 | -13.56 ± 22.346 | -24.02 ± 26.166 | -80.50 ± 31.851 | -102.80 ± 34.603 | -110.02 ± 24.119 | -10.52 ± 26.111 |
| Change at Day 113 | -73.44 ± 21.242 | -85.71 ± 30.263 | -95.83 ± 27.765 | -21.68 ± 23.686 | -31.11 ± 24.992 | -76.22 ± 36.301 | -97.89 ± 29.274 | -111.96 ± 24.871 | -5.22 ± 20.333 |
Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
| percent change | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -36.26 ± 11.313 | -42.64 ± 13.310 | -48.22 ± 11.066 | -5.47 ± 9.038 | -10.85 ± 11.295 | -32.56 ± 12.011 | -41.98 ± 12.224 | -45.28 ± 9.539 | -3.82 ± 10.484 |
| Change at Day 113 | -34.28 ± 8.799 | -40.55 ± 13.471 | -45.58 ± 12.422 | -9.18 ± 9.204 | -14.02 ± 10.900 | -30.50 ± 13.212 | -40.27 ± 11.798 | -45.71 ± 9.786 | -1.62 ± 8.941 |
ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 92.76 ± 14.383 | 92.54 ± 12.362 | 90.40 ± 12.732 | 95.65 ± 13.229 | 96.70 ± 13.382 | 106.54 ± 15.800 | 104.02 ± 14.652 | 101.88 ± 11.494 | 103.13 ± 13.608 |
| Day 5 | 67.72 ± 15.175 | 59.83 ± 14.269 | 60.26 ± 8.853 | 94.62 ± 12.847 | 84.68 ± 13.570 | 88.40 ± 18.777 | 82.88 ± 13.179 | 78.00 ± 14.025 | 104.86 ± 11.902 |
| Day 8 | 56.12 ± 12.245 | 49.04 ± 15.982 | 47.42 ± 9.050 | 95.72 ± 16.395 | 80.38 ± 13.113 | 82.52 ± 19.402 | 71.71 ± 13.614 | 70.27 ± 16.237 | 107.61 ± 11.357 |
| Day 15 | 60.20 ± 15.658 | 49.38 ± 15.528 | 36.50 ± 8.703 | 96.65 ± 13.069 | 79.36 ± 9.639 | 82.24 ± 21.127 | 62.28 ± 16.403 | 58.08 ± 12.265 | 107.39 ± 12.052 |
| Day 22 | 44.28 ± 13.227 | 36.83 ± 12.923 | 31.09 ± 5.938 | 96.35 ± 10.954 | 79.77 ± 12.976 | 68.76 ± 20.949 | 53.46 ± 14.700 | 50.54 ± 15.300 | 108.35 ± 10.530 |
| Day 29 | 52.08 ± 16.595 | 46.42 ± 16.264 | 32.83 ± 8.611 | 96.00 ± 11.800 | 80.73 ± 12.691 | 69.32 ± 20.613 | 54.20 ± 12.285 | 50.25 ± 11.752 | 107.23 ± 12.134 |
| Day 36 | 41.04 ± 11.998 | 35.50 ± 13.603 | 29.43 ± 6.036 | 96.27 ± 14.717 | 80.18 ± 13.828 | 62.40 ± 19.885 | 49.25 ± 8.115 | 46.92 ± 14.191 | 103.74 ± 13.363 |
| Day 43 | 51.36 ± 14.494 | 42.50 ± 17.942 | 31.96 ± 7.538 | 94.31 ± 9.216 | 82.68 ± 12.797 | 67.24 ± 19.959 | 53.60 ± 14.283 | 48.50 ± 14.301 | 110.39 ± 11.645 |
| Day 50 | 38.48 ± 10.759 | 34.08 ± 12.728 | 30.52 ± 6.660 | 95.69 ± 12.802 | 82.86 ± 12.822 | 62.28 ± 19.932 | 49.43 ± 11.469 | 47.58 ± 14.443 | 107.22 ± 11.062 |
| Day 57 | 49.44 ± 14.077 | 38.29 ± 16.236 | 29.48 ± 6.052 | 93.81 ± 12.316 | 79.68 ± 15.490 | 62.00 ± 19.660 | 53.25 ± 17.745 | 45.79 ± 12.322 | 104.13 ± 9.057 |
| Day 71 | 52.83 ± 16.903 | 38.71 ± 16.648 | 32.00 ± 7.634 | 97.23 ± 11.884 | 85.18 ± 14.378 | 69.96 ± 19.673 | 50.63 ± 11.568 | 47.79 ± 12.112 | 107.78 ± 16.082 |
| Day 85 | 51.32 ± 15.258 | 39.21 ± 15.291 | 33.65 ± 14.717 | 93.46 ± 12.666 | 86.77 ± 16.934 | 68.68 ± 17.409 | 49.35 ± 15.183 | 45.13 ± 10.678 | 102.09 ± 12.387 |
| Day 99 | 57.36 ± 17.291 | 44.29 ± 17.853 | 37.55 ± 18.913 | 95.08 ± 12.165 | 84.05 ± 16.247 | 72.56 ± 18.063 | 53.63 ± 17.272 | 45.88 ± 11.211 | 110.91 ± 11.049 |
| Day 106 | 42.12 ± 13.233 | 34.71 ± 15.029 | 35.55 ± 15.987 | 94.36 ± 12.192 | 83.32 ± 14.965 | 66.72 ± 17.111 | 48.87 ± 13.168 | 47.00 ± 12.332 | 107.48 ± 10.117 |
| Day 113 | 53.50 ± 13.593 | 42.83 ± 16.612 | 36.48 ± 15.111 | 88.40 ± 13.438 | 82.77 ± 15.593 | 69.08 ± 17.007 | 52.52 ± 15.774 | 45.87 ± 11.530 | 105.61 ± 9.940 |
| Day 127 | 82.00 ± 13.871 | 73.04 ± 21.566 | 54.61 ± 24.203 | 95.16 ± 12.216 | 98.50 ± 16.280 | 97.20 ± 20.827 | 69.91 ± 28.257 | 62.75 ± 19.525 | 111.35 ± 14.288 |
| Day 141 | 89.50 ± 14.611 | 87.71 ± 18.112 | 74.87 ± 25.118 | 95.08 ± 12.024 | 100.45 ± 19.043 | 108.96 ± 21.279 | 92.70 ± 27.420 | 77.67 ± 25.466 | 110.09 ± 12.109 |
| Day 155 | 90.16 ± 14.291 | 89.00 ± 15.836 | 81.87 ± 16.652 | 96.00 ± 11.832 | 101.23 ± 18.619 | 111.39 ± 17.758 | 98.26 ± 19.262 | 86.04 ± 23.451 | 108.43 ± 10.422 |
| Day 169 | 93.36 ± 16.176 | 93.63 ± 14.455 | 91.57 ± 15.147 | 96.88 ± 13.532 | 103.09 ± 20.718 | 112.46 ± 16.005 | 105.91 ± 17.661 | 95.74 ± 21.764 | 111.41 ± 9.879 |
ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -41.44 ± 16.385 | -53.33 ± 19.097 | -56.43 ± 17.650 | -2.19 ± 10.703 | -9.93 ± 14.350 | -37.86 ± 18.125 | -54.33 ± 21.080 | -56.75 ± 14.506 | -1.04 ± 13.020 |
| Change at Day 113 | -39.56 ± 12.011 | -49.71 ± 18.699 | -53.61 ± 16.526 | -7.70 ± 12.436 | -13.93 ± 12.650 | -37.46 ± 18.504 | -51.15 ± 16.855 | -56.83 ± 15.501 | 2.48 ± 11.107 |
ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
| percent change | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -44.30 ± 15.675 | -57.02 ± 17.985 | -62.31 ± 15.684 | -1.77 ± 10.567 | -9.97 ± 14.426 | -35.16 ± 15.906 | -51.62 ± 16.289 | -55.31 ± 11.060 | -0.13 ± 12.144 |
| Change at Day 113 | -42.64 ± 11.864 | -53.45 ± 18.449 | -59.48 ± 15.320 | -7.54 ± 11.662 | -14.17 ± 12.713 | -34.66 ± 16.214 | -49.10 ± 14.474 | -54.88 ± 12.109 | 3.43 ± 12.038 |
ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 137.02 ± 13.235 | 142.60 ± 16.507 | 140.31 ± 18.813 | 145.65 ± 21.908 | 145.34 ± 16.171 | 138.90 ± 21.808 | 145.38 ± 19.260 | 146.75 ± 25.587 | 150.13 ± 16.834 |
| Day 5 | 140.72 ± 14.644 | 146.65 ± 16.773 | 144.48 ± 19.943 | 146.08 ± 21.505 | 144.68 ± 16.193 | 142.12 ± 22.260 | 145.12 ± 18.485 | 149.79 ± 24.285 | 150.09 ± 17.989 |
| Day 8 | 140.44 ± 14.972 | 147.46 ± 16.707 | 146.88 ± 19.200 | 147.00 ± 21.527 | 145.57 ± 16.351 | 146.76 ± 25.406 | 145.79 ± 19.260 | 152.45 ± 28.118 | 150.48 ± 16.782 |
| Day 15 | 141.56 ± 13.811 | 153.00 ± 16.325 | 150.46 ± 20.479 | 147.04 ± 22.704 | 148.50 ± 18.918 | 145.76 ± 23.197 | 150.08 ± 20.762 | 157.04 ± 25.154 | 151.00 ± 19.214 |
| Day 22 | 143.20 ± 15.554 | 152.88 ± 18.473 | 151.78 ± 20.576 | 145.31 ± 21.481 | 146.41 ± 17.012 | 145.96 ± 22.354 | 150.08 ± 19.019 | 155.17 ± 23.265 | 151.65 ± 17.185 |
| Day 29 | 144.32 ± 15.118 | 155.79 ± 19.598 | 151.78 ± 22.913 | 144.28 ± 20.633 | 146.23 ± 17.221 | 146.36 ± 22.503 | 150.04 ± 21.763 | 155.96 ± 23.143 | 154.32 ± 15.304 |
| Day 36 | 143.48 ± 15.273 | 149.88 ± 17.957 | 150.13 ± 21.102 | 143.46 ± 20.609 | 145.91 ± 18.652 | 145.08 ± 22.953 | 153.33 ± 19.417 | 155.08 ± 24.063 | 149.30 ± 18.639 |
| Day 43 | 144.52 ± 12.842 | 153.88 ± 18.262 | 150.33 ± 22.584 | 142.42 ± 21.495 | 144.64 ± 16.105 | 146.00 ± 21.050 | 152.32 ± 21.059 | 155.75 ± 32.193 | 149.04 ± 16.932 |
| Day 50 | 145.80 ± 15.042 | 151.25 ± 19.157 | 149.13 ± 19.008 | 143.46 ± 20.397 | 141.95 ± 15.807 | 142.84 ± 21.885 | 152.52 ± 19.739 | 153.92 ± 25.100 | 145.70 ± 14.348 |
| Day 57 | 138.40 ± 14.919 | 149.46 ± 19.509 | 145.83 ± 18.930 | 137.62 ± 18.206 | 142.18 ± 15.445 | 136.32 ± 20.010 | 145.96 ± 22.029 | 144.96 ± 25.049 | 138.87 ± 16.491 |
| Day 71 | 145.50 ± 16.192 | 152.92 ± 21.086 | 150.43 ± 21.002 | 142.62 ± 19.150 | 144.18 ± 15.383 | 143.88 ± 21.896 | 151.88 ± 17.523 | 154.25 ± 23.130 | 146.17 ± 14.981 |
| Day 85 | 138.04 ± 14.968 | 148.17 ± 16.818 | 144.04 ± 15.933 | 136.00 ± 20.229 | 144.23 ± 14.498 | 132.88 ± 19.303 | 145.13 ± 17.168 | 146.58 ± 23.006 | 136.30 ± 16.753 |
| Day 99 | 147.40 ± 18.771 | 154.54 ± 17.840 | 150.86 ± 21.108 | 147.48 ± 20.799 | 145.91 ± 16.798 | 143.88 ± 19.577 | 151.29 ± 21.612 | 149.83 ± 20.750 | 144.65 ± 19.812 |
| Day 106 | 145.92 ± 18.773 | 154.96 ± 19.282 | 150.23 ± 18.341 | 143.12 ± 17.822 | 144.64 ± 15.413 | 142.56 ± 21.143 | 149.26 ± 19.909 | 150.46 ± 21.444 | 141.17 ± 15.497 |
| Day 113 | 139.21 ± 15.731 | 149.17 ± 18.719 | 144.13 ± 18.587 | 137.72 ± 21.454 | 145.00 ± 14.690 | 138.40 ± 19.581 | 149.09 ± 18.033 | 143.96 ± 21.353 | 140.04 ± 16.767 |
| Day 127 | 144.08 ± 18.630 | 148.75 ± 17.738 | 150.04 ± 23.145 | 145.60 ± 22.763 | 144.27 ± 14.701 | 141.68 ± 20.412 | 148.48 ± 18.012 | 149.17 ± 23.566 | 144.48 ± 15.237 |
| Day 141 | 145.46 ± 19.006 | 151.21 ± 18.990 | 154.17 ± 22.321 | 148.52 ± 23.261 | 144.45 ± 16.721 | 141.36 ± 20.968 | 148.74 ± 17.324 | 151.29 ± 22.831 | 149.13 ± 19.328 |
| Day 155 | 143.52 ± 17.564 | 148.83 ± 20.267 | 149.52 ± 21.848 | 147.60 ± 23.076 | 147.09 ± 16.446 | 140.96 ± 23.437 | 148.09 ± 21.037 | 149.13 ± 23.899 | 148.83 ± 18.077 |
| Day 169 | 142.96 ± 20.387 | 151.54 ± 19.010 | 150.96 ± 19.025 | 154.88 ± 23.938 | 153.64 ± 21.367 | 144.13 ± 24.746 | 151.70 ± 21.699 | 151.13 ± 29.425 | 154.36 ± 19.742 |
ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | 1.02 ± 9.479 | 5.56 ± 10.575 | 3.63 ± 11.155 | -9.65 ± 9.495 | -1.11 ± 11.118 | -6.02 ± 11.069 | -2.09 ± 12.040 | -0.17 ± 11.897 | -13.83 ± 10.602 |
| Change at Day 113 | 2.52 ± 9.226 | 6.56 ± 12.310 | 3.72 ± 11.977 | -7.86 ± 13.052 | -0.34 ± 10.783 | -0.50 ± 9.512 | 1.87 ± 9.328 | -3.54 ± 8.982 | -10.09 ± 11.236 |
ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
| percent change | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | 0.87 ± 7.002 | 4.20 ± 7.438 | 3.26 ± 8.418 | -6.44 ± 6.252 | -0.34 ± 7.749 | -3.82 ± 8.033 | -1.00 ± 8.245 | 0.44 ± 8.673 | -9.10 ± 6.738 |
| Change at Day 113 | 1.93 ± 6.789 | 4.82 ± 8.766 | 3.13 ± 8.663 | -5.16 ± 8.106 | 0.15 ± 7.819 | 0.13 ± 7.013 | 1.53 ± 6.572 | -1.84 ± 5.923 | -6.55 ± 6.903 |
ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 30.700 ± 3.6817 | 30.223 ± 2.8992 | 30.471 ± 2.8918 | 31.515 ± 3.8373 | 32.189 ± 3.2855 | 29.940 ± 3.3630 | 31.232 ± 3.9681 | 30.294 ± 3.0541 | 31.354 ± 3.9552 |
| Day 5 | 30.884 ± 3.6551 | 30.161 ± 2.9004 | 30.443 ± 3.4057 | 31.608 ± 3.6099 | 32.709 ± 3.4130 | 30.088 ± 3.4784 | 30.972 ± 4.2462 | 30.558 ± 3.0567 | 31.473 ± 4.1750 |
| Day 8 | 30.224 ± 2.8736 | 30.675 ± 3.1077 | 30.738 ± 2.9137 | 32.036 ± 3.2261 | 32.495 ± 3.0372 | 30.760 ± 3.3363 | 30.608 ± 3.8492 | 30.664 ± 3.2942 | 31.635 ± 3.6272 |
| Day 15 | 30.528 ± 3.7034 | 31.129 ± 2.9304 | 31.304 ± 3.0309 | 32.062 ± 3.2968 | 33.136 ± 3.6822 | 30.568 ± 3.3308 | 31.516 ± 3.9116 | 31.275 ± 3.4925 | 31.530 ± 4.6451 |
| Day 22 | 31.232 ± 3.1787 | 30.667 ± 3.4561 | 31.183 ± 3.8763 | 31.846 ± 3.0899 | 32.273 ± 3.2310 | 30.620 ± 3.3448 | 31.125 ± 4.0921 | 30.896 ± 3.0900 | 32.200 ± 3.6940 |
| Day 29 | 31.608 ± 3.2712 | 32.279 ± 4.1331 | 31.035 ± 3.7585 | 32.096 ± 3.6363 | 32.395 ± 3.1748 | 30.740 ± 3.0899 | 31.100 ± 3.6272 | 31.071 ± 2.8639 | 31.882 ± 3.6960 |
| Day 36 | 31.208 ± 3.5747 | 30.838 ± 3.3920 | 30.622 ± 3.3870 | 31.150 ± 3.3011 | 32.091 ± 4.0243 | 29.768 ± 3.2825 | 31.404 ± 4.0581 | 30.975 ± 3.3526 | 31.478 ± 3.7066 |
| Day 43 | 31.600 ± 3.8155 | 31.908 ± 4.2809 | 31.004 ± 3.6090 | 31.685 ± 3.6743 | 32.636 ± 3.1568 | 30.720 ± 3.6371 | 32.408 ± 4.0300 | 31.138 ± 3.4691 | 31.922 ± 3.8381 |
| Day 50 | 31.772 ± 3.9676 | 31.117 ± 3.5511 | 30.991 ± 2.9264 | 31.900 ± 3.5621 | 32.282 ± 3.5327 | 29.760 ± 3.8077 | 32.704 ± 3.8668 | 31.083 ± 3.8423 | 30.830 ± 3.7644 |
| Day 57 | 30.708 ± 5.1285 | 30.271 ± 4.0390 | 29.987 ± 3.2086 | 30.773 ± 3.4292 | 32.405 ± 3.0798 | 28.548 ± 3.8710 | 31.454 ± 4.3687 | 30.033 ± 3.9031 | 29.861 ± 3.3007 |
| Day 71 | 32.600 ± 4.3091 | 31.554 ± 4.3823 | 31.148 ± 2.8016 | 32.092 ± 3.5748 | 33.127 ± 3.3208 | 30.260 ± 3.9125 | 32.658 ± 3.9677 | 31.804 ± 3.5119 | 31.317 ± 4.0283 |
| Day 85 | 30.484 ± 4.5441 | 30.296 ± 4.2019 | 29.974 ± 3.3766 | 30.577 ± 4.1019 | 33.095 ± 3.4642 | 29.036 ± 3.6811 | 31.957 ± 4.8917 | 30.533 ± 4.0376 | 29.657 ± 3.6082 |
| Day 99 | 32.868 ± 4.2145 | 32.054 ± 4.3729 | 31.436 ± 3.7821 | 32.500 ± 4.3987 | 33.155 ± 3.9087 | 31.352 ± 3.8161 | 32.925 ± 5.9562 | 31.229 ± 2.9670 | 31.570 ± 4.3204 |
| Day 106 | 31.908 ± 4.1181 | 31.850 ± 3.8284 | 31.073 ± 3.3504 | 31.724 ± 3.5444 | 32.432 ± 3.6429 | 30.520 ± 3.9332 | 32.552 ± 4.3131 | 31.438 ± 3.7623 | 30.865 ± 3.7092 |
| Day 113 | 30.442 ± 4.1097 | 30.313 ± 4.1545 | 29.787 ± 3.3975 | 30.388 ± 3.3572 | 32.559 ± 3.0055 | 29.300 ± 3.3821 | 32.361 ± 4.1480 | 30.239 ± 3.2747 | 30.126 ± 3.5101 |
| Day 127 | 32.068 ± 3.9869 | 31.358 ± 3.9263 | 31.370 ± 3.4158 | 31.824 ± 3.4922 | 32.905 ± 3.2614 | 30.904 ± 3.1115 | 32.374 ± 3.7973 | 31.242 ± 3.5215 | 31.839 ± 3.7256 |
| Day 141 | 32.704 ± 4.5005 | 32.325 ± 4.2787 | 32.835 ± 3.3582 | 32.044 ± 4.2146 | 32.818 ± 3.4188 | 31.412 ± 3.6261 | 33.287 ± 3.0694 | 32.029 ± 3.4970 | 32.178 ± 3.1213 |
| Day 155 | 32.164 ± 3.9476 | 31.629 ± 4.4463 | 31.878 ± 3.3637 | 31.956 ± 4.1374 | 32.877 ± 3.7858 | 31.061 ± 3.8024 | 32.891 ± 4.0870 | 31.867 ± 3.6487 | 31.439 ± 3.4050 |
| Day 169 | 31.848 ± 4.1778 | 32.033 ± 3.8588 | 32.352 ± 3.8903 | 33.120 ± 4.2339 | 33.623 ± 4.2722 | 31.433 ± 3.8678 | 33.578 ± 4.4671 | 32.070 ± 3.9987 | 32.345 ± 3.6908 |
ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -0.216 ± 2.2274 | 0.073 ± 2.6605 | -0.450 ± 2.3906 | -0.938 ± 1.8339 | 0.907 ± 2.6785 | -0.904 ± 2.3894 | 0.354 ± 3.3769 | 0.240 ± 3.1812 | -1.698 ± 2.9589 |
| Change at Day 113 | -0.073 ± 2.0937 | 0.090 ± 2.3882 | -0.637 ± 2.2412 | -1.104 ± 4.0438 | 0.370 ± 2.2388 | -0.640 ± 2.0394 | 0.759 ± 2.2739 | 0.002 ± 2.8256 | -1.228 ± 3.4404 |
ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
| percent change | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -0.85 ± 7.387 | 0.17 ± 8.699 | -1.34 ± 7.672 | -2.93 ± 5.741 | 3.13 ± 8.288 | -2.87 ± 7.788 | 1.34 ± 10.779 | 0.98 ± 10.565 | -4.97 ± 9.262 |
| Change at Day 113 | -0.21 ± 6.972 | 0.13 ± 7.974 | -1.99 ± 7.403 | -2.77 ± 11.234 | 1.48 ± 6.776 | -1.94 ± 6.337 | 2.64 ± 7.315 | 0.39 ± 9.526 | -3.29 ± 10.137 |
Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 18.452 ± 13.1792 | 20.998 ± 17.2111 | 18.840 ± 16.7289 | 19.265 ± 14.3646 | 19.468 ± 18.4181 | 14.080 ± 11.9369 | 15.458 ± 12.6296 | 13.400 ± 9.0719 | 16.239 ± 10.1883 |
| Day 5 | 16.224 ± 13.4935 | 18.348 ± 17.7316 | 16.204 ± 16.6072 | 18.523 ± 15.2512 | 20.450 ± 18.8904 | 12.464 ± 10.5751 | 14.580 ± 12.2541 | 11.783 ± 9.3506 | 15.859 ± 10.9932 |
| Day 8 | 14.892 ± 13.2944 | 15.333 ± 18.3499 | 14.167 ± 15.5022 | 19.184 ± 14.7461 | 17.243 ± 15.7353 | 12.000 ± 11.8358 | 12.617 ± 10.4189 | 12.768 ± 8.9168 | 16.443 ± 12.1793 |
| Day 15 | 14.208 ± 12.9280 | 14.129 ± 17.8567 | 11.392 ± 14.1251 | 19.258 ± 16.0484 | 18.982 ± 20.4348 | 10.140 ± 10.0017 | 12.548 ± 10.9860 | 9.996 ± 8.1113 | 16.443 ± 11.4594 |
| Day 22 | 12.628 ± 12.4393 | 12.446 ± 16.1397 | 10.765 ± 13.3504 | 18.785 ± 16.0604 | 17.800 ± 18.6499 | 10.936 ± 10.1920 | 11.583 ± 11.3914 | 8.800 ± 7.1835 | 16.026 ± 11.0080 |
| Day 29 | 12.832 ± 12.3874 | 13.379 ± 16.2405 | 10.552 ± 12.7986 | 18.304 ± 15.6050 | 17.873 ± 18.0678 | 10.424 ± 10.6085 | 10.888 ± 9.8450 | 9.312 ± 7.3675 | 17.423 ± 11.1746 |
| Day 36 | 11.152 ± 11.9088 | 12.833 ± 16.0418 | 10.409 ± 12.7145 | 17.046 ± 14.4893 | 18.050 ± 19.5448 | 9.484 ± 10.6692 | 10.329 ± 9.7943 | 8.067 ± 6.7186 | 15.843 ± 10.8050 |
| Day 43 | 11.648 ± 12.2798 | 12.525 ± 16.1360 | 9.633 ± 12.4360 | 16.912 ± 14.1356 | 17.214 ± 18.6825 | 9.380 ± 9.6416 | 9.944 ± 9.7431 | 8.821 ± 7.6426 | 15.961 ± 10.3890 |
| Day 50 | 10.344 ± 11.3684 | 11.675 ± 14.8818 | 9.039 ± 12.0250 | 16.835 ± 14.2068 | 17.314 ± 19.6439 | 10.040 ± 10.4835 | 10.191 ± 9.2630 | 7.621 ± 6.5659 | 15.078 ± 9.7608 |
| Day 57 | 10.708 ± 10.3883 | 10.871 ± 13.5224 | 8.578 ± 11.2275 | 15.892 ± 14.0990 | 17.573 ± 21.9401 | 9.392 ± 10.2457 | 9.487 ± 8.2801 | 6.858 ± 6.2894 | 14.313 ± 9.3930 |
| Day 71 | 11.358 ± 12.3793 | 11.354 ± 14.0492 | 9.009 ± 11.7733 | 16.542 ± 13.5029 | 16.991 ± 20.0151 | 9.248 ± 11.4972 | 9.529 ± 8.6412 | 6.979 ± 6.5414 | 13.500 ± 9.4333 |
| Day 85 | 10.960 ± 11.6806 | 10.879 ± 14.1289 | 9.239 ± 11.1448 | 16.519 ± 14.5691 | 17.609 ± 19.7001 | 8.808 ± 10.3417 | 9.261 ± 7.6804 | 6.637 ± 5.6695 | 12.726 ± 8.9598 |
| Day 99 | 12.232 ± 12.5326 | 11.837 ± 15.6082 | 8.855 ± 13.9399 | 15.764 ± 14.4527 | 16.868 ± 19.6709 | 7.940 ± 9.6343 | 8.537 ± 7.6094 | 6.792 ± 5.6212 | 13.691 ± 9.5937 |
| Day 106 | 10.756 ± 11.7377 | 11.079 ± 14.2590 | 9.123 ± 14.1064 | 15.396 ± 12.8944 | 16.682 ± 18.8434 | 8.608 ± 9.5662 | 8.296 ± 7.3410 | 6.858 ± 6.1058 | 12.800 ± 8.9601 |
| Day 113 | 12.108 ± 12.3479 | 11.183 ± 14.5312 | 9.565 ± 14.0691 | 14.492 ± 12.9060 | 16.814 ± 17.8976 | 8.020 ± 9.0412 | 8.287 ± 7.6439 | 6.787 ± 5.8743 | 12.913 ± 9.7212 |
| Day 127 | 15.476 ± 14.6308 | 15.112 ± 16.5781 | 11.961 ± 15.6073 | 15.500 ± 13.0255 | 16.618 ± 19.1791 | 9.864 ± 10.2016 | 10.543 ± 9.2205 | 7.642 ± 6.9977 | 13.596 ± 9.3340 |
| Day 141 | 16.842 ± 15.6809 | 17.329 ± 18.9837 | 14.422 ± 17.3620 | 15.828 ± 13.7114 | 17.236 ± 18.8525 | 10.100 ± 10.9325 | 11.996 ± 10.0494 | 8.442 ± 6.7945 | 13.139 ± 9.2951 |
| Day 155 | 17.264 ± 15.4506 | 17.483 ± 19.9385 | 16.052 ± 16.9174 | 16.004 ± 13.7418 | 17.382 ± 19.8297 | 10.204 ± 11.2720 | 13.465 ± 10.8114 | 9.600 ± 7.5028 | 13.183 ± 9.1710 |
| Day 169 | 17.824 ± 15.1879 | 17.404 ± 18.0405 | 16.635 ± 17.8211 | 15.384 ± 13.7150 | 17.059 ± 20.8409 | 11.271 ± 11.4561 | 13.613 ± 11.5074 | 10.626 ± 8.0902 | 14.741 ± 10.3647 |
Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -7.492 ± 5.1400 | -10.119 ± 5.4374 | -10.239 ± 8.2471 | -2.746 ± 3.1292 | -1.859 ± 3.0759 | -5.272 ± 5.1528 | -7.100 ± 5.9402 | -6.763 ± 5.3474 | -3.513 ± 3.6550 |
| Change at Day 113 | -6.815 ± 4.6182 | -9.815 ± 5.0568 | -9.913 ± 6.6763 | -3.574 ± 4.0251 | -2.655 ± 3.1725 | -6.060 ± 4.5477 | -8.074 ± 6.0886 | -7.098 ± 4.5025 | -3.326 ± 3.4975 |
Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
| percent change | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -47.11 ± 20.802 | -58.53 ± 22.181 | -46.51 ± 63.192 | -19.37 ± 25.160 | -15.22 ± 23.532 | -37.85 ± 27.223 | -37.29 ± 24.552 | -43.37 ± 39.755 | -18.40 ± 30.139 |
| Change at Day 113 | -42.30 ± 19.223 | -57.94 ± 22.317 | -59.42 ± 21.689 | -24.35 ± 21.348 | -18.64 ± 18.300 | -45.26 ± 22.490 | -47.60 ± 19.448 | -49.77 ± 25.417 | -15.89 ± 36.642 |
HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 54.58 ± 9.048 | 54.75 ± 11.789 | 57.00 ± 12.858 | 58.54 ± 14.683 | 56.98 ± 9.607 | 57.22 ± 14.146 | 60.40 ± 13.228 | 62.02 ± 21.455 | 60.87 ± 10.606 |
| Day 5 | 55.68 ± 11.131 | 57.04 ± 12.532 | 58.43 ± 13.480 | 58.19 ± 14.403 | 57.00 ± 9.866 | 57.20 ± 15.785 | 60.32 ± 13.643 | 62.08 ± 21.354 | 59.73 ± 11.344 |
| Day 8 | 56.48 ± 11.266 | 58.38 ± 12.700 | 60.33 ± 13.017 | 60.52 ± 14.234 | 58.67 ± 10.136 | 59.60 ± 15.729 | 61.33 ± 14.230 | 64.00 ± 23.420 | 60.57 ± 11.289 |
| Day 15 | 58.52 ± 8.637 | 59.96 ± 11.925 | 62.79 ± 15.562 | 59.35 ± 15.179 | 60.23 ± 12.208 | 60.24 ± 16.048 | 62.32 ± 15.513 | 66.58 ± 22.085 | 60.30 ± 11.117 |
| Day 22 | 59.36 ± 11.158 | 60.08 ± 12.176 | 64.52 ± 14.585 | 58.08 ± 12.743 | 60.05 ± 10.017 | 60.92 ± 16.253 | 63.92 ± 13.529 | 65.38 ± 17.358 | 61.48 ± 11.233 |
| Day 29 | 59.96 ± 10.486 | 61.75 ± 13.553 | 63.83 ± 15.948 | 57.96 ± 13.192 | 59.00 ± 9.587 | 60.84 ± 16.222 | 62.52 ± 15.196 | 67.96 ± 20.412 | 64.14 ± 9.896 |
| Day 36 | 57.92 ± 10.622 | 60.50 ± 13.112 | 62.39 ± 14.151 | 57.62 ± 13.518 | 58.23 ± 10.314 | 59.76 ± 14.521 | 65.25 ± 14.411 | 65.21 ± 19.489 | 59.91 ± 10.833 |
| Day 43 | 59.76 ± 8.724 | 62.21 ± 13.266 | 62.29 ± 15.415 | 57.31 ± 13.936 | 58.82 ± 10.450 | 59.36 ± 14.950 | 63.64 ± 15.435 | 65.17 ± 18.846 | 59.74 ± 10.558 |
| Day 50 | 60.12 ± 10.248 | 60.04 ± 12.185 | 62.09 ± 14.058 | 57.81 ± 14.525 | 58.55 ± 10.835 | 59.40 ± 14.955 | 64.91 ± 13.651 | 65.21 ± 19.669 | 59.39 ± 10.586 |
| Day 57 | 58.40 ± 8.221 | 58.83 ± 13.830 | 60.35 ± 13.231 | 54.88 ± 12.745 | 57.45 ± 10.804 | 57.16 ± 12.589 | 61.92 ± 14.374 | 62.63 ± 20.549 | 56.61 ± 10.782 |
| Day 71 | 60.29 ± 9.438 | 62.96 ± 14.0492 | 64.83 ± 16.854 | 56.85 ± 12.069 | 58.00 ± 9.798 | 59.16 ± 13.539 | 63.92 ± 14.185 | 66.29 ± 20.354 | 57.78 ± 9.662 |
| Day 85 | 58.24 ± 9.926 | 59.54 ± 12.827 | 59.70 ± 11.315 | 53.96 ± 12.981 | 59.77 ± 10.438 | 55.04 ± 13.421 | 63.09 ± 13.211 | 62.00 ± 17.619 | 56.35 ± 10.075 |
| Day 99 | 62.68 ± 11.926 | 62.54 ± 13.462 | 62.32 ± 14.496 | 59.92 ± 12.812 | 60.36 ± 10.472 | 60.00 ± 13.051 | 64.54 ± 15.453 | 64.63 ± 18.946 | 59.30 ± 12.430 |
| Day 106 | 62.36 ± 11.489 | 63.25 ± 15.118 | 64.41 ± 13.355 | 58.28 ± 12.651 | 59.45 ± 10.117 | 60.08 ± 15.231 | 64.39 ± 15.718 | 65.17 ± 18.897 | 58.30 ± 11.703 |
| Day 113 | 58.13 ± 11.395 | 61.04 ± 14.245 | 59.39 ± 12.565 | 55.28 ± 13.145 | 60.32 ± 10.049 | 57.92 ± 14.617 | 63.00 ± 14.331 | 61.83 ± 18.218 | 56.17 ± 10.421 |
| Day 127 | 59.16 ± 12.212 | 59.46 ± 13.552 | 62.78 ± 14.013 | 60.72 ± 15.118 | 57.82 ± 9.272 | 58.56 ± 13.818 | 63.61 ± 16.160 | 63.88 ± 19.161 | 58.00 ± 10.838 |
| Day 141 | 60.58 ± 11.960 | 60.63 ± 13.682 | 64.26 ± 14.530 | 60.96 ± 15.970 | 59.09 ± 10.766 | 59.40 ± 16.081 | 63.26 ± 14.229 | 64.00 ± 20.167 | 62.39 ± 14.138 |
| Day 155 | 58.72 ± 10.620 | 59.00 ± 14.341 | 61.96 ± 14.455 | 59.48 ± 14.535 | 59.45 ± 9.179 | 59.04 ± 16.425 | 63.00 ± 15.021 | 63.67 ± 20.550 | 61.87 ± 13.602 |
| Day 169 | 57.48 ± 11.794 | 59.04 ± 12.726 | 62.48 ± 14.441 | 61.88 ± 15.078 | 60.50 ± 11.827 | 60.29 ± 16.206 | 62.04 ± 15.155 | 65.00 ± 24.355 | 65.05 ± 13.584 |
HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | 3.66 ± 6.216 | 4.79 ± 5.568 | 2.63 ± 5.394 | -4.58 ± 4.573 | 2.80 ± 6.223 | -2.18 ± 6.065 | 1.46 ± 7.408 | -0.02 ± 7.575 | -4.52 ± 5.191 |
| Change at Day 113 | 3.90 ± 6.437 | 6.29 ± 7.003 | 2.33 ± 8.053 | -3.28 ± 7.264 | 3.34 ± 5.702 | 0.70 ± 6.489 | 1.37 ± 7.799 | -0.63 ± 6.995 | -4.70 ± 5.045 |
HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
| percent change | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | 7.26 ± 10.914 | 9.46 ± 11.132 | 5.86 ± 9.988 | -7.31 ± 7.254 | 5.42 ± 10.501 | -3.10 ± 10.471 | 2.93 ± 11.259 | 2.35 ± 12.101 | -7.16 ± 8.271 |
| Change at Day 113 | 7.39 ± 11.623 | 11.97 ± 13.385 | 5.27 ± 12.612 | -4.83 ± 9.919 | 6.31 ± 9.989 | 1.86 ± 11.617 | 2.35 ± 10.959 | 1.05 ± 10.017 | -7.53 ± 7.966 |
VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 19.92 ± 9.312 | 23.79 ± 11.286 | 20.92 ± 7.651 | 21.42 ± 6.858 | 22.48 ± 7.869 | 17.44 ± 7.509 | 17.66 ± 9.090 | 16.63 ± 6.273 | 17.50 ± 8.549 |
| Day 5 | 21.36 ± 9.999 | 19.70 ± 8.249 | 17.22 ± 5.977 | 23.85 ± 10.657 | 21.95 ± 8.249 | 19.80 ± 11.927 | 16.08 ± 8.356 | 18.00 ± 10.065 | 20.68 ± 10.035 |
| Day 8 | 19.64 ± 13.073 | 18.00 ± 6.574 | 15.58 ± 6.192 | 21.72 ± 10.577 | 20.29 ± 7.100 | 18.64 ± 9.995 | 16.25 ± 6.661 | 18.95 ± 9.810 | 22.48 ± 13.737 |
| Day 15 | 17.20 ± 8.921 | 20.42 ± 9.930 | 16.50 ± 9.869 | 23.04 ± 9.035 | 22.68 ± 9.712 | 18.52 ± 9.265 | 16.28 ± 8.735 | 16.25 ± 10.605 | 20.43 ± 10.612 |
| Day 22 | 17.04 ± 6.761 | 19.04 ± 7.410 | 14.65 ± 6.786 | 21.65 ± 7.573 | 21.59 ± 7.866 | 17.20 ± 7.984 | 16.42 ± 6.580 | 17.17 ± 14.199 | 18.13 ± 9.416 |
| Day 29 | 15.76 ± 7.253 | 19.88 ± 9.967 | 15.39 ± 4.717 | 21.88 ± 9.523 | 22.73 ± 10.552 | 17.00 ± 7.746 | 19.68 ± 16.106 | 13.04 ± 6.753 | 19.00 ± 8.258 |
| Day 36 | 18.96 ± 9.361 | 15.33 ± 4.984 | 14.04 ± 5.842 | 21.92 ± 9.587 | 21.59 ± 9.169 | 17.28 ± 6.901 | 16.46 ± 6.129 | 15.50 ± 5.905 | 24.22 ± 17.231 |
| Day 43 | 16.56 ± 6.246 | 21.33 ± 13.770 | 18.04 ± 10.813 | 23.65 ± 12.547 | 20.95 ± 7.712 | 20.00 ± 7.708 | 18.12 ± 7.316 | 16.96 ± 6.734 | 22.78 ± 11.631 |
| Day 50 | 16.36 ± 9.269 | 17.67 ± 6.787 | 14.39 ± 6.966 | 21.69 ± 11.235 | 19.23 ± 6.718 | 17.48 ± 8.186 | 17.04 ± 7.151 | 15.54 ± 7.818 | 22.26 ± 13.685 |
| Day 57 | 14.36 ± 6.034 | 17.46 ± 8.939 | 13.87 ± 4.674 | 20.88 ± 7.957 | 21.55 ± 5.878 | 15.44 ± 5.108 | 16.83 ± 12.437 | 13.54 ± 4.222 | 20.13 ± 10.092 |
| Day 71 | 15.92 ± 7.064 | 17.50 ± 9.212 | 13.83 ± 3.950 | 21.77 ± 9.868 | 20.82 ± 8.151 | 19.04 ± 6.846 | 16.79 ± 6.840 | 14.63 ± 6.337 | 22.61 ± 9.014 |
| Day 85 | 14.24 ± 6.247 | 17.63 ± 8.816 | 14.04 ± 6.745 | 22.58 ± 7.991 | 19.77 ± 5.936 | 16.68 ± 7.040 | 14.09 ± 6.735 | 14.04 ± 4.639 | 16.43 ± 8.877 |
| Day 99 | 16.20 ± 6.371 | 18.04 ± 10.378 | 18.68 ± 17.700 | 21.72 ± 11.085 | 20.14 ± 7.298 | 17.84 ± 6.756 | 16.46 ± 9.514 | 16.21 ± 8.490 | 21.13 ± 8.981 |
| Day 106 | 14.44 ± 6.545 | 15.96 ± 6.328 | 14.59 ± 5.981 | 19.32 ± 7.330 | 18.64 ± 6.499 | 17.76 ± 7.573 | 16.09 ± 5.672 | 13.13 ± 5.788 | 20.00 ± 9.376 |
| Day 113 | 15.83 ± 8.726 | 16.54 ± 7.863 | 15.26 ± 5.056 | 21.88 ± 14.701 | 18.50 ± 7.951 | 15.92 ± 8.246 | 15.96 ± 8.466 | 13.87 ± 6.107 | 19.39 ± 8.322 |
| Day 127 | 20.48 ± 11.594 | 23.21 ± 14.231 | 16.61 ± 7.686 | 19.32 ± 9.534 | 21.59 ± 7.992 | 19.72 ± 8.091 | 17.91 ± 11.445 | 17.38 ± 12.631 | 21.61 ± 13.121 |
| Day 141 | 18.13 ± 7.279 | 22.25 ± 15.109 | 17.39 ± 5.007 | 19.16 ± 9.573 | 23.68 ± 9.564 | 19.52 ± 10.627 | 17.61 ± 7.518 | 18.54 ± 9.913 | 20.09 ± 9.409 |
| Day 155 | 17.00 ± 3.905 | 22.21 ± 11.858 | 16.52 ± 7.141 | 20.56 ± 9.319 | 21.41 ± 7.028 | 19.30 ± 9.632 | 16.17 ± 8.144 | 18.92 ± 10.738 | 18.57 ± 9.110 |
| Day 169 | 18.88 ± 7.732 | 21.42 ± 7.442 | 17.30 ± 6.292 | 19.60 ± 7.286 | 24.55 ± 11.931 | 19.13 ± 8.644 | 23.00 ± 23.279 | 18.00 ± 10.167 | 19.68 ± 8.306 |
VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -5.68 ± 6.973 | -6.17 ± 7.171 | -6.57 ± 6.726 | 1.15 ± 4.841 | -2.70 ± 7.069 | -0.76 ± 5.114 | -2.63 ± 9.497 | -2.58 ± 7.290 | -1.07 ± 4.989 |
| Change at Day 113 | -4.29 ± 8.538 | -7.25 ± 9.067 | -5.35 ± 6.619 | 0.34 ± 10.957 | -3.98 ± 8.873 | -1.52 ± 5.771 | -0.76 ± 9.276 | -2.98 ± 6.998 | 1.89 ± 5.762 |
VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
| percent change | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -23.42 ± 30.458 | -22.99 ± 25.647 | -28.96 ± 25.281 | 7.08 ± 26.054 | -6.48 ± 27.276 | -7.61 ± 23.163 | 5.66 ± 76.931 | -3.54 ± 45.821 | -3.63 ± 39.826 |
| Change at Day 113 | -17.23 ± 35.083 | -26.62 ± 28.464 | -19.28 ± 33.794 | -1.89 ± 43.239 | -10.80 ± 38.288 | -9.72 ± 29.006 | 10.72 ± 65.297 | -10.36 ± 36.732 | 18.73 ± 48.065 |
Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 121.04 ± 56.152 | 158.21 ± 71.477 | 127.65 ± 59.878 | 140.23 ± 51.283 | 152.59 ± 50.105 | 122.40 ± 50.578 | 124.40 ± 59.717 | 111.58 ± 42.354 | 130.39 ± 49.826 |
| Day 5 | 134.20 ± 78.692 | 130.30 ± 58.718 | 112.17 ± 47.884 | 154.27 ± 74.707 | 146.41 ± 76.274 | 128.20 ± 79.256 | 115.40 ± 52.401 | 114.25 ± 61.969 | 121.09 ± 48.602 |
| Day 8 | 126.44 ± 123.041 | 124.58 ± 49.786 | 95.71 ± 42.796 | 150.40 ± 76.908 | 128.43 ± 50.155 | 122.72 ± 66.459 | 103.50 ± 48.515 | 130.91 ± 75.156 | 136.91 ± 91.378 |
| Day 15 | 109.52 ± 65.672 | 143.96 ± 70.871 | 123.96 ± 108.066 | 149.31 ± 64.392 | 145.91 ± 79.420 | 125.64 ± 55.667 | 113.52 ± 60.601 | 114.25 ± 54.003 | 130.65 ± 53.724 |
| Day 22 | 105.56 ± 45.283 | 119.17 ± 55.800 | 101.96 ± 54.725 | 133.65 ± 48.535 | 144.64 ± 68.531 | 125.00 ± 54.636 | 109.04 ± 49.088 | 113.79 ± 106.198 | 130.26 ± 59.246 |
| Day 29 | 97.84 ± 49.164 | 133.38 ± 74.370 | 100.04 ± 39.343 | 147.92 ± 68.536 | 130.00 ± 52.743 | 111.24 ± 46.683 | 142.84 ± 141.763 | 94.29 ± 37.698 | 122.09 ± 49.749 |
| Day 36 | 113.68 ± 71.769 | 111.25 ± 45.529 | 96.52 ± 56.535 | 154.65 ± 59.929 | 139.95 ± 79.796 | 115.12 ± 54.424 | 109.17 ± 54.052 | 105.67 ± 38.421 | 158.30 ± 102.642 |
| Day 43 | 108.16 ± 56.609 | 161.75 ± 134.409 | 130.71 ± 124.380 | 159.19 ± 85.270 | 135.23 ± 70.762 | 123.80 ± 52.925 | 119.44 ± 53.110 | 109.29 ± 54.365 | 140.61 ± 73.706 |
| Day 50 | 108.12 ± 65.442 | 126.58 ± 56.883 | 100.57 ± 52.553 | 148.50 ± 77.558 | 121.64 ± 51.406 | 123.48 ± 61.199 | 114.22 ± 53.090 | 113.29 ± 53.870 | 142.30 ± 83.014 |
| Day 57 | 94.40 ± 49.048 | 124.25 ± 69.357 | 92.52 ± 45.106 | 139.50 ± 56.099 | 137.55 ± 53.502 | 102.28 ± 33.512 | 117.21 ± 84.666 | 90.67 ± 28.925 | 136.78 ± 67.987 |
| Day 71 | 103.13 ± 51.243 | 125.50 ± 74.428 | 93.91 ± 39.340 | 156.27 ± 65.687 | 139.27 ± 85.017 | 122.68 ± 52.192 | 112.13 ± 56.034 | 103.13 ± 47.534 | 146.43 ± 64.368 |
| Day 85 | 92.36 ± 47.872 | 130.25 ± 78.800 | 95.00 ± 54.102 | 142.81 ± 57.891 | 142.45 ± 60.126 | 118.64 ± 46.593 | 100.04 ± 53.185 | 99.92 ± 40.798 | 119.17 ± 57.046 |
| Day 99 | 110.56 ± 57.944 | 128.25 ± 70.840 | 131.32 ± 118.340 | 156.84 ± 70.931 | 137.82 ± 60.866 | 122.96 ± 55.697 | 118.17 ± 63.727 | 115.08 ± 63.629 | 133.91 ± 49.879 |
| Day 106 | 97.80 ± 46.662 | 116.29 ± 50.480 | 102.59 ± 50.880 | 131.68 ± 55.816 | 133.41 ± 68.902 | 116.16 ± 55.618 | 109.91 ± 45.304 | 93.54 ± 38.520 | 139.00 ± 53.142 |
| Day 113 | 101.58 ± 51.130 | 112.88 ± 60.824 | 94.39 ± 34.093 | 141.64 ± 96.032 | 129.14 ± 73.031 | 111.72 ± 53.875 | 116.26 ± 69.771 | 101.43 ± 52.274 | 136.61 ± 64.291 |
| Day 127 | 133.40 ± 71.046 | 159.25 ± 101.582 | 115.96 ± 63.954 | 133.40 ± 66.304 | 153.14 ± 62.304 | 138.08 ± 60.533 | 139.83 ± 103.182 | 124.50 ± 86.402 | 159.43 ± 89.130 |
| Day 141 | 115.13 ± 51.964 | 164.79 ± 129.257 | 123.39 ± 35.150 | 131.08 ± 56.266 | 156.27 ± 76.965 | 135.80 ± 75.159 | 119.91 ± 59.343 | 129.13 ± 70.190 | 137.35 ± 56.775 |
| Day 155 | 115.44 ± 39.459 | 164.13 ± 102.919 | 113.83 ± 43.209 | 139.44 ± 65.901 | 149.23 ± 68.510 | 129.00 ± 70.010 | 119.91 ± 61.088 | 133.33 ± 81.100 | 131.74 ± 62.736 |
| Day 169 | 120.76 ± 56.962 | 151.63 ± 59.252 | 122.43 ± 65.091 | 149.40 ± 58.176 | 167.91 ± 79.436 | 126.67 ± 60.290 | 166.22 ± 176.973 | 128.26 ± 71.260 | 125.41 ± 36.439 |
Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -28.68 ± 41.898 | -27.96 ± 49.754 | -29.52 ± 40.669 | 2.58 ± 35.796 | -10.14 ± 43.129 | -3.76 ± 37.502 | -15.87 ± 48.341 | -11.67 ± 42.519 | -11.22 ± 23.797 |
| Change at Day 113 | -20.02 ± 41.197 | -45.33 ± 53.285 | -30.13 ± 48.592 | -0.58 ± 63.896 | -23.45 ± 51.443 | -10.68 ± 27.488 | 0.35 ± 48.858 | -12.46 ± 44.128 | 6.22 ± 32.888 |
Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
| percent change | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -21.00 ± 31.109 | -16.85 ± 28.672 | -23.38 ± 24.421 | 3.74 ± 27.803 | -5.20 ± 23.919 | 2.62 ± 33.715 | -9.40 ± 42.868 | -5.21 ± 35.698 | -9.33 ± 19.235 |
| Change at Day 113 | -14.44 ± 26.916 | -27.65 ± 26.827 | -17.70 ± 29.263 | -3.82 ± 36.247 | -15.23 ± 24.917 | -8.31 ± 19.500 | 1.32 ± 37.694 | -8.47 ± 35.865 | 4.57 ± 29.077 |
Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 159.58 ± 29.033 | 155.54 ± 20.706 | 154.71 ± 22.511 | 163.90 ± 25.271 | 165.86 ± 26.655 | 188.72 ± 30.222 | 182.86 ± 22.842 | 182.17 ± 21.217 | 181.17 ± 23.577 |
| Day 5 | 113.52 ± 28.259 | 97.78 ± 25.034 | 98.48 ± 15.003 | 161.23 ± 22.059 | 140.77 ± 26.324 | 154.36 ± 35.666 | 143.24 ± 23.520 | 137.50 ± 28.770 | 189.36 ± 24.432 |
| Day 8 | 93.24 ± 22.966 | 79.33 ± 27.140 | 76.17 ± 15.222 | 162.16 ± 29.067 | 131.52 ± 23.712 | 142.84 ± 36.478 | 123.25 ± 25.378 | 122.73 ± 29.183 | 193.70 ± 20.424 |
| Day 15 | 95.68 ± 27.248 | 77.88 ± 27.299 | 57.96 ± 16.134 | 162.35 ± 20.558 | 130.27 ± 19.489 | 138.40 ± 38.794 | 103.16 ± 26.742 | 99.13 ± 22.099 | 191.61 ± 22.845 |
| Day 22 | 69.92 ± 23.315 | 58.92 ± 23.638 | 48.26 ± 10.037 | 160.04 ± 19.838 | 130.59 ± 24.595 | 115.36 ± 37.861 | 88.71 ± 24.172 | 88.29 ± 28.964 | 192.09 ± 18.757 |
| Day 29 | 81.08 ± 26.644 | 71.79 ± 26.662 | 51.09 ± 14.820 | 159.16 ± 20.163 | 133.41 ± 30.589 | 115.52 ± 38.434 | 90.68 ± 25.610 | 82.46 ± 20.659 | 192.59 ± 23.425 |
| Day 36 | 66.20 ± 21.848 | 53.38 ± 22.329 | 44.96 ± 10.598 | 159.46 ± 25.221 | 129.32 ± 29.451 | 103.72 ± 37.651 | 81.83 ± 15.898 | 79.42 ± 26.345 | 184.74 ± 25.913 |
| Day 43 | 79.64 ± 23.937 | 66.63 ± 30.685 | 51.46 ± 14.926 | 157.31 ± 16.790 | 132.05 ± 29.005 | 112.60 ± 37.446 | 88.16 ± 23.005 | 82.08 ± 27.547 | 194.30 ± 22.876 |
| Day 50 | 59.92 ± 17.814 | 52.58 ± 21.847 | 45.65 ± 11.276 | 157.62 ± 22.608 | 130.64 ± 25.964 | 101.60 ± 36.427 | 80.30 ± 20.448 | 78.96 ± 27.207 | 186.70 ± 20.220 |
| Day 57 | 75.76 ± 23.552 | 58.13 ± 23.709 | 44.26 ± 9.186 | 153.15 ± 19.601 | 126.68 ± 28.919 | 101.80 ± 35.249 | 86.08 ± 30.679 | 73.21 ± 24.568 | 180.17 ± 17.167 |
| Day 71 | 81.83 ± 28.164 | 58.08 ± 26.357 | 48.65 ± 13.110 | 161.54 ± 22.089 | 134.91 ± 30.239 | 115.48 ± 36.001 | 82.25 ± 22.283 | 76.13 ± 22.793 | 185.96 ± 28.798 |
| Day 85 | 77.28 ± 25.268 | 60.04 ± 23.665 | 49.87 ± 24.464 | 154.92 ± 22.289 | 139.05 ± 36.247 | 110.40 ± 30.783 | 78.00 ± 27.144 | 72.17 ± 18.874 | 175.17 ± 24.398 |
| Day 99 | 88.56 ± 28.234 | 66.04 ± 29.895 | 60.05 ± 35.754 | 156.36 ± 18.830 | 133.68 ± 34.790 | 118.36 ± 32.875 | 85.29 ± 30.599 | 74.50 ± 19.496 | 190.52 ± 20.551 |
| Day 106 | 64.04 ± 24.315 | 51.50 ± 23.178 | 54.14 ± 28.648 | 154.08 ± 19.378 | 130.82 ± 29.301 | 107.76 ± 31.232 | 77.87 ± 23.470 | 74.75 ± 22.115 | 183.35 ± 19.664 |
| Day 113 | 82.50 ± 24.128 | 63.54 ± 25.086 | 55.78 ± 27.153 | 146.36 ± 23.787 | 131.41 ± 32.515 | 111.80 ± 30.993 | 83.00 ± 27.632 | 72.35 ± 20.232 | 180.65 ± 16.489 |
| Day 127 | 134.80 ± 24.100 | 117.42 ± 37.408 | 85.09 ± 41.318 | 158.60 ± 22.504 | 163.36 ± 33.835 | 164.60 ± 38.791 | 113.13 ± 46.332 | 102.75 ± 33.666 | 191.78 ± 28.623 |
| Day 141 | 149.17 ± 29.556 | 142.08 ± 32.188 | 119.83 ± 42.083 | 155.52 ± 20.490 | 170.41 ± 37.185 | 187.96 ± 41.528 | 154.17 ± 45.140 | 128.96 ± 44.304 | 191.09 ± 24.978 |
| Day 155 | 149.60 ± 26.876 | 144.83 ± 26.836 | 133.30 ± 30.526 | 161.80 ± 21.960 | 169.41 ± 37.377 | 190.96 ± 34.453 | 164.83 ± 34.193 | 144.58 ± 40.902 | 184.48 ± 18.030 |
| Day 169 | 155.48 ± 28.791 | 153.75 ± 25.535 | 148.52 ± 27.770 | 159.12 ± 20.961 | 174.45 ± 41.877 | 193.88 ± 33.789 | 183.52 ± 37.346 | 162.65 ± 40.341 | 193.59 ± 17.816 |
Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
| mg/dL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -82.30 ± 30.323 | -95.50 ± 32.345 | -104.07 ± 27.573 | -8.98 ± 20.888 | -26.82 ± 28.796 | -78.32 ± 33.436 | -104.26 ± 34.056 | -110.00 ± 24.274 | -6.00 ± 24.009 |
| Change at Day 113 | -77.33 ± 22.371 | -92.00 ± 32.099 | -98.15 ± 28.798 | -18.40 ± 22.784 | -34.45 ± 26.242 | -76.92 ± 35.588 | -99.26 ± 27.347 | -111.33 ± 24.646 | -0.52 ± 20.267 |
Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
| percent change | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -50.98 ± 15.662 | -60.62 ± 17.746 | -67.69 ± 14.462 | -4.77 ± 11.716 | -16.20 ± 16.334 | -41.11 ± 16.193 | -56.87 ± 14.745 | -60.17 ± 10.493 | -2.49 ± 12.951 |
| Change at Day 113 | -48.56 ± 12.284 | -58.57 ± 17.970 | -63.92 ± 15.872 | -10.59 ± 11.977 | -20.67 ± 15.155 | -40.19 ± 17.244 | -54.54 ± 13.671 | -60.43 ± 11.070 | 0.88 ± 13.236 |
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
| ratio | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 4.0118 ± 0.82813 | 4.0154 ± 0.92478 | 3.8500 ± 0.72414 | 3.9629 ± 0.77435 | 4.0223 ± 0.81145 | 4.5408 ± 1.11809 | 4.2558 ± 1.15512 | 4.2610 ± 1.08481 | 4.1076 ± 0.88524 |
| Day 5 | 3.1372 ± 0.81529 | 2.7861 ± 0.57451 | 2.7500 ± 0.38981 | 3.9465 ± 0.83527 | 3.5668 ± 0.77085 | 3.9264 ± 1.11497 | 3.5036 ± 0.76250 | 3.4029 ± 0.86267 | 4.3259 ± 0.99932 |
| Day 8 | 2.7252 ± 0.63762 | 2.4100 ± 0.53023 | 2.3083 ± 0.33483 | 3.8588 ± 0.92894 | 3.3510 ± 0.79979 | 3.6024 ± 1.07004 | 3.1367 ± 0.80233 | 3.0941 ± 0.80907 | 4.3374 ± 0.88617 |
| Day 15 | 2.6884 ± 0.58429 | 2.3754 ± 0.62550 | 1.9658 ± 0.33815 | 3.9308 ± 0.89274 | 3.2700 ± 0.68229 | 3.4940 ± 1.02033 | 2.7772 ± 0.71059 | 2.6050 ± 0.53948 | 4.3017 ± 0.84316 |
| Day 22 | 2.2428 ± 0.53640 | 2.0258 ± 0.49301 | 1.7730 ± 0.18504 | 3.8915 ± 0.75155 | 3.2550 ± 0.66627 | 3.0676 ± 0.92151 | 2.4338 ± 0.43218 | 2.3617 ± 0.35946 | 4.2822 ± 0.97569 |
| Day 29 | 2.4020 ± 0.54386 | 2.2533 ± 0.64125 | 1.8296 ± 0.26896 | 3.8852 ± 0.73498 | 3.3318 ± 0.70099 | 3.0260 ± 0.77510 | 2.5780 ± 0.75738 | 2.2800 ± 0.37240 | 4.1023 ± 0.81890 |
| Day 36 | 2.1924 ± 0.45842 | 1.9300 ± 0.46830 | 1.7404 ± 0.18627 | 3.9496 ± 0.92977 | 3.2882 ± 0.68375 | 2.8452 ± 0.78785 | 2.3000 ± 0.31095 | 2.2529 ± 0.39114 | 4.2222 ± 0.97022 |
| Day 43 | 2.3688 ± 0.48338 | 2.1396 ± 0.61972 | 1.8754 ± 0.39255 | 3.9338 ± 0.87409 | 3.3259 ± 0.70739 | 3.0044 ± 0.77172 | 2.5124 ± 0.80082 | 2.3004 ± 0.42044 | 4.4074 ± 1.03394 |
| Day 50 | 2.0280 ± 0.36876 | 1.9254 ± 0.48864 | 1.7443 ± 0.15406 | 3.9419 ± 0.98670 | 3.3277 ± 0.71213 | 2.8300 ± 0.81738 | 2.2883 ± 0.38697 | 2.2658 ± 0.43915 | 4.2909 ± 0.97014 |
| Day 57 | 2.3148 ± 0.44657 | 2.0758 ± 0.63508 | 1.7448 ± 0.12638 | 3.9596 ± 0.84943 | 3.2632 ± 0.60608 | 2.8436 ± 0.67094 | 2.5708 ± 1.24941 | 2.2225 ± 0.37721 | 4.3361 ± 0.97295 |
| Day 71 | 2.3925 ± 0.57023 | 1.9988 ± 0.56686 | 1.7709 ± 0.19489 | 4.0085 ± 0.93120 | 3.3855 ± 0.64850 | 3.0528 ± 0.77095 | 2.3258 ± 0.34951 | 2.1988 ± 0.36789 | 4.3791 ± 1.15180 |
| Day 85 | 2.3724 ± 0.52972 | 2.0721 ± 0.54913 | 1.8561 ± 0.49386 | 4.0508 ± 0.91154 | 3.3986 ± 0.73940 | 3.1204 ± 0.72628 | 2.2796 ± 0.46691 | 2.2142 ± 0.37394 | 4.2613 ± 1.08945 |
| Day 99 | 2.4564 ± 0.54658 | 2.1417 ± 0.70783 | 2.0305 ± 0.76914 | 3.7648 ± 0.83515 | 3.3073 ± 0.81497 | 3.0868 ± 0.75654 | 2.4075 ± 0.70042 | 2.2121 ± 0.37358 | 4.4200 ± 1.15874 |
| Day 106 | 2.0476 ± 0.40004 | 1.8650 ± 0.50620 | 1.8814 ± 0.56847 | 3.7912 ± 0.78337 | 3.2832 ± 0.72097 | 2.9176 ± 0.75101 | 2.2517 ± 0.37291 | 2.1896 ± 0.37808 | 4.3157 ± 1.01377 |
| Day 113 | 2.4688 ± 0.50001 | 2.1042 ± 0.55015 | 1.9691 ± 0.52016 | 3.8248 ± 0.91875 | 3.2359 ± 0.65683 | 3.0760 ± 0.78321 | 2.3639 ± 0.45213 | 2.2335 ± 0.42128 | 4.3570 ± 0.88681 |
| Day 127 | 3.3776 ± 0.67839 | 3.1533 ± 0.98795 | 2.4822 ± 0.91213 | 3.7984 ± 0.90030 | 3.9132 ± 0.79683 | 3.9896 ± 0.99046 | 2.9087 ± 0.92317 | 2.8208 ± 1.08222 | 4.4717 ± 1.06069 |
| Day 141 | 3.5433 ± 0.67339 | 3.5242 ± 0.96281 | 3.0078 ± 0.91134 | 3.7508 ± 0.88092 | 3.9841 ± 0.87530 | 4.4256 ± 1.20555 | 3.6070 ± 1.06034 | 3.3500 ± 1.37776 | 4.2843 ± 1.17378 |
| Day 155 | 3.6240 ± 0.63587 | 3.6392 ± 0.92468 | 3.2748 ± 0.76307 | 3.9100 ± 0.92453 | 3.9205 ± 0.79163 | 4.5057 ± 1.18175 | 3.8126 ± 0.99748 | 3.6450 ± 1.45582 | 4.1804 ± 1.03516 |
| Day 169 | 3.8140 ± 0.77275 | 3.7471 ± 0.82852 | 3.4830 ± 0.67010 | 3.7436 ± 0.86236 | 4.0036 ± 0.99761 | 4.4975 ± 1.25117 | 4.2000 ± 1.23292 | 3.8970 ± 1.40230 | 4.1182 ± 0.81436 |
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
| ratio | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -1.6394 ± 0.69058 | -1.9433 ± 0.90358 | -1.9835 ± 0.78766 | 0.0879 ± 0.43755 | -0.6236 ± 0.66072 | -1.4204 ± 0.91892 | -1.8407 ± 0.85260 | -2.0469 ± 0.96230 | 0.1537 ± 0.47755 |
| Change at Day 113 | -1.5671 ± 0.65875 | -1.9113 ± 0.93385 | -1.8704 ± 0.73630 | -0.1560 ± 0.53286 | -0.7864 ± 0.60966 | -1.4648 ± 0.83864 | -1.7563 ± 0.74752 | -2.0461 ± 0.92038 | 0.2493 ± 0.43772 |
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
| percent change | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -39.99 ± 12.892 | -47.06 ± 15.152 | -50.43 ± 13.358 | 2.19 ± 10.328 | -14.65 ± 14.740 | -29.51 ± 16.200 | -43.25 ± 12.569 | -45.74 ± 11.961 | 3.81 ± 10.643 |
| Change at Day 113 | -38.20 ± 10.463 | -46.04 ± 15.705 | -47.68 ± 13.195 | -3.81 ± 12.537 | -18.57 ± 13.541 | -31.07 ± 14.770 | -41.49 ± 10.520 | -45.65 ± 12.114 | 6.98 ± 12.436 |
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
| ratio | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 0.6846 ± 0.14145 | 0.6606 ± 0.13665 | 0.6567 ± 0.12772 | 0.6687 ± 0.12269 | 0.6775 ± 0.14076 | 0.7890 ± 0.17841 | 0.7324 ± 0.16556 | 0.7167 ± 0.16058 | 0.6980 ± 0.13867 |
| Day 5 | 0.4896 ± 0.14794 | 0.4135 ± 0.11264 | 0.4222 ± 0.07116 | 0.6612 ± 0.12682 | 0.5968 ± 0.14211 | 0.6428 ± 0.18885 | 0.5792 ± 0.11372 | 0.5300 ± 0.11967 | 0.7100 ± 0.12642 |
| Day 8 | 0.4044 ± 0.09862 | 0.3363 ± 0.11305 | 0.3271 ± 0.06760 | 0.6660 ± 0.14947 | 0.5657 ± 0.14552 | 0.5844 ± 0.18410 | 0.5017 ± 0.12310 | 0.4718 ± 0.13900 | 0.7230 ± 0.11227 |
| Day 15 | 0.4308 ± 0.12426 | 0.3300 ± 0.12322 | 0.2450 ± 0.05649 | 0.6712 ± 0.13137 | 0.5445 ± 0.11164 | 0.5776 ± 0.16885 | 0.4216 ± 0.11929 | 0.3763 ± 0.08293 | 0.7226 ± 0.13404 |
| Day 22 | 0.3136 ± 0.10610 | 0.2463 ± 0.09668 | 0.2078 ± 0.04572 | 0.6773 ± 0.13012 | 0.5564 ± 0.13347 | 0.4868 ± 0.17148 | 0.3629 ± 0.10897 | 0.3283 ± 0.09220 | 0.7248 ± 0.12409 |
| Day 29 | 0.3656 ± 0.12076 | 0.3058 ± 0.12721 | 0.2196 ± 0.05943 | 0.6776 ± 0.12337 | 0.5609 ± 0.11924 | 0.4820 ± 0.14437 | 0.3720 ± 0.11247 | 0.3254 ± 0.07524 | 0.7023 ± 0.11439 |
| Day 36 | 0.2900 ± 0.09278 | 0.2421 ± 0.10206 | 0.1983 ± 0.04376 | 0.6873 ± 0.15278 | 0.5600 ± 0.13551 | 0.4428 ± 0.15255 | 0.3250 ± 0.06093 | 0.3050 ± 0.08900 | 0.7048 ± 0.13413 |
| Day 43 | 0.3592 ± 0.10723 | 0.2800 ± 0.12399 | 0.2142 ± 0.05012 | 0.6788 ± 0.12944 | 0.5805 ± 0.11978 | 0.4696 ± 0.15115 | 0.3632 ± 0.14522 | 0.3188 ± 0.09124 | 0.7548 ± 0.16351 |
| Day 50 | 0.2668 ± 0.07669 | 0.2313 ± 0.10182 | 0.2048 ± 0.04088 | 0.6804 ± 0.13489 | 0.5959 ± 0.13893 | 0.4472 ± 0.16198 | 0.3283 ± 0.08917 | 0.3133 ± 0.09234 | 0.7465 ± 0.13878 |
| Day 57 | 0.3584 ± 0.09715 | 0.2642 ± 0.13319 | 0.2026 ± 0.04081 | 0.6938 ± 0.12747 | 0.5682 ± 0.13297 | 0.4616 ± 0.15220 | 0.3804 ± 0.18286 | 0.3196 ± 0.07765 | 0.7630 ± 0.13394 |
| Day 71 | 0.3692 ± 0.12402 | 0.2592 ± 0.11602 | 0.2157 ± 0.05281 | 0.6958 ± 0.13840 | 0.5986 ± 0.12434 | 0.4976 ± 0.15592 | 0.3358 ± 0.07678 | 0.3146 ± 0.08086 | 0.7500 ± 0.17328 |
| Day 85 | 0.3768 ± 0.11546 | 0.2696 ± 0.11705 | 0.2335 ± 0.10170 | 0.7023 ± 0.13946 | 0.6132 ± 0.16069 | 0.5264 ± 0.14405 | 0.3435 ± 0.11007 | 0.3125 ± 0.08125 | 0.7665 ± 0.18376 |
| Day 99 | 0.3928 ± 0.12458 | 0.2904 ± 0.12791 | 0.2491 ± 0.12432 | 0.6584 ± 0.13120 | 0.5882 ± 0.15930 | 0.5164 ± 0.15168 | 0.3650 ± 0.15223 | 0.3075 ± 0.07170 | 0.7883 ± 0.18622 |
| Day 106 | 0.2908 ± 0.08450 | 0.2267 ± 0.10925 | 0.2405 ± 0.12187 | 0.6716 ± 0.12925 | 0.5877 ± 0.15253 | 0.4796 ± 0.14386 | 0.3322 ± 0.09130 | 0.3142 ± 0.08230 | 0.7730 ± 0.14455 |
| Day 113 | 0.3888 ± 0.10343 | 0.2908 ± 0.11858 | 0.2548 ± 0.10845 | 0.6556 ± 0.14192 | 0.5777 ± 0.12976 | 0.5140 ± 0.15398 | 0.3557 ± 0.10710 | 0.3235 ± 0.08804 | 0.7683 ± 0.14272 |
| Day 127 | 0.5772 ± 0.11473 | 0.5029 ± 0.17571 | 0.3778 ± 0.19064 | 0.6692 ± 0.13546 | 0.6950 ± 0.15732 | 0.7024 ± 0.18033 | 0.4730 ± 0.18425 | 0.4325 ± 0.16469 | 0.7830 ± 0.15893 |
| Day 141 | 0.6233 ± 0.12107 | 0.5938 ± 0.15786 | 0.5004 ± 0.19354 | 0.6580 ± 0.13916 | 0.7082 ± 0.17595 | 0.7916 ± 0.20262 | 0.6352 ± 0.20727 | 0.5375 ± 0.23022 | 0.7570 ± 0.17219 |
| Day 155 | 0.6368 ± 0.11957 | 0.6125 ± 0.15224 | 0.5574 ± 0.13288 | 0.6664 ± 0.13225 | 0.6991 ± 0.17124 | 0.8148 ± 0.20102 | 0.6839 ± 0.19315 | 0.6075 ± 0.24120 | 0.7452 ± 0.16318 |
| Day 169 | 0.6640 ± 0.14350 | 0.6321 ± 0.14774 | 0.6161 ± 0.12493 | 0.6424 ± 0.14621 | 0.6845 ± 0.17986 | 0.8088 ± 0.20105 | 0.7178 ± 0.18178 | 0.6639 ± 0.22661 | 0.7359 ± 0.13397 |
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
| ratio | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -0.3078 ± 0.13144 | -0.3910 ± 0.15635 | -0.4211 ± 0.16147 | 0.0337 ± 0.09054 | -0.0643 ± 0.11318 | -0.2626 ± 0.16341 | -0.3748 ± 0.17224 | -0.4042 ± 0.14894 | 0.0685 ± 0.10818 |
| Change at Day 113 | -0.2998 ± 0.12105 | -0.3698 ± 0.16194 | -0.3998 ± 0.15163 | -0.0170 ± 0.10303 | -0.0998 ± 0.09487 | -0.2750 ± 0.15604 | -0.3626 ± 0.14553 | -0.3965 ± 0.15431 | 0.0702 ± 0.09306 |
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
| percent change | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Change at Day 85 | -44.37 ± 16.358 | -58.47 ± 19.271 | -63.09 ± 16.240 | 5.51 ± 12.823 | -9.13 ± 16.695 | -32.09 ± 18.463 | -50.97 ± 16.380 | -55.16 ± 11.927 | 10.41 ± 15.319 |
| Change at Day 113 | -43.21 ± 13.147 | -55.05 ± 19.756 | -60.32 ± 15.924 | -2.03 ± 14.326 | -14.00 ± 14.205 | -34.11 ± 18.505 | -49.84 ± 13.744 | -53.65 ± 13.386 | 11.47 ± 16.250 |
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection.
| percentage of participants | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|
| LDL-C <10 mg/dL | 0.0 | 4.2 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| LDL-C <25 mg/dL | 12.0 | 66.7 | 58.3 | 0.0 | 0.0 | 0.0 | 20.8 | 0.0 |
| LDL-C <40 mg/dL | 84.0 | 91.7 | 95.8 | 0.0 | 12.0 | 36.0 | 41.7 | 0.0 |
| LDL-C <70 mg/dL | 96.0 | 100.0 | 100.0 | 0.0 | 64.0 | 92.0 | 87.5 | 0.0 |
| LDL-C <100 mg/dL | 100.0 | 100.0 | 100.0 | 23.1 | 92.0 | 100.0 | 100.0 | 4.3 |
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 169 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included treatment emergent injection site adverse events and any clinically significant abnormal laboratory value.
| participants | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| AEs | 17 | 16 | 13 | 13 | 5 | 16 | 16 | 15 | 11 |
| SAEs | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level \>=6.23 for PF-04950615 were considered ADA positive.
| participants | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|
| Number of Participants With Anti-Drug Antibody (ADA) Response | 14 | 6 | 14 | — | 13 | 16 | 11 | — |
Area under the plasma concentration time-curve from time zero to end of dosing interval (tau). This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
| microgram*day per milliliter(mcg*day/mL) | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg |
|---|---|---|---|---|---|---|
| Single dose | 32.98 ± 57 | 52.33 ± 49 | 77.11 ± 43 | 32.97 ± 42 | 51.49 ± 46 | 82.05 ± 45 |
| Multiple dose | 63.54 ± 40 | 92.46 ± 127 | 242.5 ± 81 | 63.74 ± 57 | 136.6 ± 32 | 273.5 ± 100 |
Area under the plasma concentration-time profile from time zero extrapolated to infinite time. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
| mcg*day/mL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg |
|---|---|---|---|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-04950615 | 94.83 ± 46 | 176.9 ± 144 | 469.5 ± 90 | 111.7 ± 63 | 237.4 ± 41 | 248.4 ± 76 |
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
| mcg*day/mL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg |
|---|---|---|---|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615 | 87.86 ± 49 | 140.3 ± 145 | 434.2 ± 91 | 96.32 ± 65 | 220.9 ± 39 | 486.7 ± 143 |
This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
| microgram per milliliter (mcg/mL) | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg |
|---|---|---|---|---|---|---|
| Single dose | 3.173 ± 61 | 5.074 ± 50 | 7.382 ± 45 | 2.994 ± 44 | 4.744 ± 47 | 7.726 ± 42 |
| Multiple dose | 6.197 ± 36 | 8.343 ± 119 | 21.91 ± 76 | 5.874 ± 55 | 12.22 ± 29 | 23.64 ± 88 |
This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
| mcg/mL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg |
|---|---|---|---|---|---|---|
| Minimum Observed Plasma Trough Concentration (Cmin) of PF-04950615 | 2.176 ± 65 | 4.041 ± 147 | 12.95 ± 94 | 2.858 ± 64 | 6.571 ± 40 | 13.47 ± 139 |
This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
| day | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg |
|---|---|---|---|---|---|---|
| Single dose | 4.01 (3.00 to 5.96) | 4.97 (3.94 to 7.00) | 5.94 (1.94 to 7.00) | 5.94 (3.94 to 6.95) | 5.45 (2.95 to 6.94) | 6.94 (2.96 to 14.0) |
| Multiple dose | 3.03 (2.92 to 6.98) | 2.98 (1.00 to 4.97) | 2.97 (0.964 to 4.99) | 2.99 (0.985 to 7.06) | 2.98 (0.988 to 4.98) | 4.98 (2.97 to 7.00) |
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
| day | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg |
|---|---|---|---|---|---|---|
| Terminal Elimination Half-Life (t1/2) of PF-04950615 | 7.716 ± 1.7594 | 9.471 ± 2.2889 | 10.56 ± 1.5934 | 9.404 ± 2.1454 | 9.570 ± 2.2338 | 9.333 ± 2.7535 |
Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =6.99 nanogram per milliliter \[ng/mL\]) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| ng/mL | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|
| Day 1 | 266.64 ± 61.5494 | 261.23 ± 72.3625 | 285.96 ± 75.7940 | 269.19 ± 66.8377 | 228.80 ± 49.9983 | 215.50 ± 43.0086 | 234.42 ± 77.5410 | 210.22 ± 48.5536 |
| Day 5 | 2292.2 ± 676.414 | 2152.6 ± 451.749 | 1997.7 ± 563.722 | 291.77 ± 65.8011 | 1952.5 ± 527.661 | 1775.4 ± 531.225 | 1712.0 ± 458.574 | 240.41 ± 63.093 |
| Day 8 | 2711.2 ± 614.649 | 2701.9 ± 568.958 | 2539.5 ± 587.196 | 292.19 ± 62.5108 | 2490.4 ± 573.777 | 2297.7 ± 521.003 | 2306.7 ± 594.409 | 240.22 ± 53.5842 |
| Day 15 | 2539.8 ± 558.369 | 3198.1 ± 897.565 | 3291.9 ± 624.935 | 303.42 ± 47.9418 | 2590.6 ± 601.052 | 3030.8 ± 715.193 | 2966.7 ± 713.934 | 224.43 ± 57.6903 |
| Day 22 | 3451.7 ± 872.597 | 3297.3 ± 701.137 | 3166.5 ± 663.295 | 295 ± 71.6996 | 3117.4 ± 582.258 | 2971.6 ± 669.215 | 2726.7 ± 616.409 | 218.82 ± 41.2647 |
| Day 29 | 2844.2 ± 684.693 | 3224.8 ± 868.760 | 3419.8 ± 715.001 | 275 ± 57.6888 | 3050.0 ± 534.176 | 3095.5 ± 647.481 | 2955.6 ± 678.703 | 230.09 ± 44.1742 |
| Day 36 | 3446.2 ± 825.704 | 3310.7 ± 732.706 | 3248.5 ± 660.213 | 304.75 ± 48.529 | 3237.0 ± 694.727 | 3011.2 ± 578.469 | 2761.4 ± 601.567 | 233.09 ± 56.7693 |
| Day 43 | 2900.9 ± 653.572 | 3406.3 ± 765.437 | 3391.9 ± 717.922 | 303.54 ± 81.0823 | 3278.9 ± 693.207 | 3302.5 ± 584.658 | 3016.9 ± 772.615 | 239.13 ± 43.8782 |
| Day 50 | 3394.8 ± 750.557 | 3297.2 ± 654.384 | 3230.9 ± 716.416 | 293.38 ± 66.9138 | 3148.5 ± 541.230 | 3001.3 ± 696.256 | 2820.3 ± 693.130 | 237.40 ± 68.2421 |
| Day 57 | 2779.2 ± 698.727 | 3204.8 ± 699.490 | 3390.6 ± 1149.17 | 277.69 ± 70.6132 | 2910.6 ± 531.493 | 3026.4 ± 708.490 | 2791.9 ± 633.717 | 220.13 ± 66.99 |
| Day 71 | 2889.6 ± 542.831 | 3241.2 ± 724.363 | 3280.5 ± 727.932 | 285.81 ± 45.5315 | 3066.8 ± 693.445 | 3197.1 ± 575.162 | 2887.6 ± 684.734 | 355.17 ± 556.079 |
| Day 85 | 2727.0 ± 635.595 | 3166.3 ± 736.216 | 3198.9 ± 827.313 | 276.31 ± 72.3396 | 2898.7 ± 551.114 | 2934.1 ± 548.311 | 2787.9 ± 812.792 | 269.61 ± 201.161 |
| Day 99 | 2915.1 ± 711.932 | 3242.9 ± 684.758 | 3259.6 ± 754.730 | 326.08 ± 78.8759 | 3119.2 ± 665.408 | 3149.3 ± 590.228 | 2918.9 ± 752.647 | 252.13 ± 72.1011 |
| Day 106 | 3326.7 ± 611.790 | 3138.9 ± 604.177 | 2864.0 ± 596.757 | 283.67 ± 58.9079 | 3165.7 ± 786.665 | 2755.7 ± 549.755 | 2566.5 ± 483.133 | 242.23 ± 59.4266 |
| Day 113 | 2727.3 ± 710.746 | 2919.0 ± 511.959 | 2910.3 ± 609.380 | 267.71 ± 68.1498 | 2908.4 ± 639.771 | 3009.8 ± 685.462 | 2683.9 ± 574.842 | 222.05 ± 46.0574 |
| Day 127 | 1429.8 ± 599.406 | 2148.7 ± 1062.32 | 3030.7 ± 607.610 | 281.40 ± 95.7562 | 1778.9 ± 872.368 | 2556.0 ± 772.015 | 2769.7 ± 736.453 | 249.87 ± 63.2113 |
| Day 141 | 736.63 ± 297.087 | 1382.8 ± 892.457 | 2851.0 ± 1373.69 | 290.16 ± 84.2168 | 1056.5 ± 545.337 | 1477.0 ± 816.342 | 2368.7 ± 1106.62 | 20.043 ± 68.7012 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Atorvastatin + PF-04950615 50 mg | — | 1/25 (4%) | 10/25 (40%) |
| Atorvastatin + PF-04950615 100 mg | — | 0/24 (0%) | 12/24 (50%) |
| Atorvastatin + PF-04950615 150 mg | — | 0/24 (0%) | 12/24 (50%) |
| Atorvastatin + PF-04950615 Placebo | — | 1/26 (3.8%) | 10/26 (38.5%) |
| Atorvastatin + Ezetimibe 10 mg QD PO | — | 0/22 (0%) | 2/22 (9.1%) |
| PF-04950615 50 mg | — | 0/25 (0%) | 11/25 (44%) |
| PF-04950615 100 mg | — | 1/25 (4%) | 11/25 (44%) |
| PF-04950615 150 mg | — | 0/24 (0%) | 11/24 (45.8%) |
| PF-04950615 Placebo | — | 0/23 (0%) | 9/23 (39.1%) |
| Event | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg QD PO | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| CellulitisInfections and infestations | 1/25 | 0/24 | 0/24 | 0/26 | 0/22 | 0/25 | 0/25 | 0/24 | 0/23 |
| Spinal compression fractureInjury, poisoning and procedural complications | 0/25 | 0/24 | 0/24 | 0/26 | 0/22 | 0/25 | 1/25 | 0/24 | 0/23 |
| Angina pectorisCardiac disorders | 0/25 | 0/24 | 0/24 | 1/26 | 0/22 | 0/25 | 0/25 | 0/24 | 0/23 |
| Event | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg QD PO | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Injection site erythemaGeneral disorders | 2/25 | 6/24 | 8/24 | 0/26 | 0/22 | 4/25 | 7/25 | 6/24 | 1/23 |
| Injection site pruritusGeneral disorders | 2/25 | 4/24 | 7/24 | 0/26 | 0/22 | 4/25 | 6/25 | 5/24 | 0/23 |
| PharyngitisInfections and infestations | 1/25 | 0/24 | 1/24 | 0/26 | 0/22 | 0/25 | 0/25 | 5/24 | 0/23 |
| NasopharyngitisInfections and infestations | 5/25 | 1/24 | 1/24 | 5/26 | 1/22 | 3/25 | 4/25 | 2/24 | 4/23 |
| Injection site painGeneral disorders | 0/25 | 1/24 | 0/24 | 0/26 | 0/22 | 0/25 | 0/25 | 3/24 | 0/23 |
| Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders | 2/25 | 3/24 | 0/24 | 2/26 | 0/22 | 0/25 | 0/25 | 0/24 | 0/23 |
| FallInjury, poisoning and procedural complications | 1/25 | 1/24 | 0/24 | 1/26 | 0/22 | 0/25 | 3/25 | 0/24 | 1/23 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/25 | 1/24 | 0/24 | 1/26 | 0/22 | 3/25 | 0/25 | 0/24 | 1/23 |
| EczemaSkin and subcutaneous tissue disorders | 1/25 | 0/24 | 0/24 | 0/26 | 1/22 | 3/25 | 0/25 | 0/24 | 1/23 |
| ContusionInjury, poisoning and procedural complications | 0/25 | 1/24 | 0/24 | 0/26 | 0/22 | 0/25 | 1/25 | 0/24 | 2/23 |
Safety analysis set included all randomized and non-randomized participants who were administered at least 1 dose of study treatment.
| Age, Customized(Participants) | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Less than (<) 18 years | 0 ± 8.9 | 0 ± 12.2 | 0 ± 8.6 | 0 ± 11.2 | 0 ± 10.7 | 0 ± 8.4 | 0 ± 10.6 | 0 ± 8.1 | 0 ± 11.7 | 0 |
| 18-44 years | 1 | 3 | 1 | 3 | 2 | 1 | 3 | 3 | 2 | 19 |
| 45-64 years | 18 | 10 | 16 | 14 | 14 | 16 | 14 | 20 | 12 | 134 |
| Greater than or equal to (>=) 65 years | 6 | 11 | 7 | 9 | 6 | 8 | 8 | 1 | 9 | 65 |
| Sex: Female, Male(Participants) | Atorvastatin + PF-04950615 50 mg | Atorvastatin + PF-04950615 100 mg | Atorvastatin + PF-04950615 150 mg | Atorvastatin + PF-04950615 Placebo | Atorvastatin + Ezetimibe 10 mg | PF-04950615 50 mg | PF-04950615 100 mg | PF-04950615 150 mg | PF-04950615 Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 8 | 10 | 12 | 13 | 10 | 13 | 15 | 9 | 10 | 100 |
| Male | 17 | 14 | 12 | 13 | 12 | 12 | 10 | 15 | 13 | 118 |
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