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CompletedNCT00862251Updated May 16, 2024Results posted

Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)

A Phase 3 interventional study of ezetimibe (+) simvastatin and simvastatin 40 mg or atorvastatin 20 mg in Cardiovascular Disorder and Diabetes Mellitus, sponsored by Organon and Co. Completed. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
808
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study summary

The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg.

02

Conditions studied

  • Cardiovascular Disorder
  • Diabetes Mellitus

Keywords

  • cardiovascular disorder
03

In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

This study's enrollment of 808 is above the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Browse Organon & Co. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient has not taken common statins or ezetimibe within 6 weeks of study screening or patient is currently taking a daily dose of the following statins for 6 weeks prior to study screening: simvastatin, atorvastatin, pravastatin, fluvastatin, ezetimibe, lovastatin, or ezetimibe + fluvastatin
  • Patient is willing to go on a cholesterol and glucose lowering diet for the duration of the study
  • Patient is willing to remain abstinent or use birth control for the duration of the study
  • Patient has Diabetes Mellitus with cardiovascular disease

Exclusion criteria

Exclusion Criteria:

  • Patient has sensitivity to certain common statin drugs
  • Patient is Asian and would not be able to start taking the higher doses of rosuvastatin necessary for the study design
  • Patient consumes more than 2 alcoholic drinks per day
  • Patient is pregnant or breast-feeding
  • Patient has been treated with other investigational drugs within 30 days of first visit
  • Patient is currently on prohibited doses of the following statin drugs: rosuvastatin, simvastatin, atorvastatin, and pravastatin
  • Patient has congestive heart failure
  • Patient has uncontrolled high blood pressure
  • Patient has kidney disease
  • Patient has uncontrolled endocrine or metabolic disease which are known to possibly increase blood lipoproteins
  • Patient has diabetes mellitus that is not well controlled
  • Patient is human immunodeficiency virus (HIV) positive
  • Patient is currently taking medications that inhibit Cytochrome P450 3A4 (CYP3A4)
  • Patient is currently taking therapies that would increase the risk of muscle weakness
  • Patient has been taking certain over- the-counter lipid-lowering agents within 6 weeks prior to visit 1
  • Patient is currently taking psyllium or other fiber-based laxatives
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
808 participants (actual)

Study arms

  • Experimental
    Ezetimibe/simvastatin

    Drug: ezetimibe (+) simvastatin · Drug: atorvastatin 10 mg or simvastatin 20 mg

  • Active comparator
    Doubling statin dose

    Drug: simvastatin 40 mg or atorvastatin 20 mg · Drug: atorvastatin 10 mg or simvastatin 20 mg

  • Active comparator
    Rosuvastatin

    Drug: Rosuvastatin · Drug: atorvastatin 10 mg or simvastatin 20 mg

Interventions

  • Drugezetimibe (+) simvastatin

    Drug pages: Ezetimibe · Simvastatin

    ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.

    Also known as: Vytorin

  • Drugsimvastatin 40 mg or atorvastatin 20 mg

    simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.

    Also known as: Lipitor, Zocor

  • DrugRosuvastatin

    rosuvastatin 10 mg tablets, taken once daily for six weeks.

    Also known as: Crestor

  • Drugatorvastatin 10 mg or simvastatin 20 mg

    All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.

    Also known as: Lipitor, Zocor

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin).

    Time frame: Baseline and Week 6

Secondary outcomes

  1. In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin

    Time frame: Baseline and Week 6

  2. In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin

    Time frame: Baseline and Week 6

  3. Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin

    Time frame: Baseline and Week 6

  4. Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)

    Time frame: Week 6

  5. In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)

    Time frame: Week 6

  6. In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)

    Time frame: Week 6

  7. Percent Change From Baseline in Total Cholesterol (TC)

    Time frame: Baseline and Week 6

  8. Percent Change From Baseline in Triglycerides

    Time frame: Baseline and Week 6

  9. Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)

    Time frame: Baseline and Week 6

  10. Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

    Time frame: Baseline and Week 6

  11. Percent Change From Baseline in LDL-C/HDL-C Ratio

    Time frame: Baseline and Week 6

  12. Percent Change From Baseline in TC/HDL-C Ratio

    Time frame: Baseline and Week 6

  13. Percent Change From Baseline in Non-HDL-C/HDL-C Ratio

    Time frame: Baseline and Week 6

  14. Percent Change From Baseline in Apolipoprotein B (Apo B)

    Time frame: Baseline and Week 6

  15. Percent Change From Baseline Apolipoprotein A-I (Apo A-I)

    Time frame: Baseline and Week 6

  16. Percent Change From Baseline in Apo B/Apo A-I Ratio

    Time frame: Baseline and Week 6

  17. Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)

    Time frame: Baseline and Week 6

07

Results

Posted Mar 16, 2012

Participant flow

Participant flow — Overall Study
MilestoneEzetimibe/SimvastatinDoubling Statin DoseRosuvastatin
Started322162324
Completed303157315
Not completed1959
Withdrew: Adverse event831
Withdrew: Lost to follow-up001
Withdrew: Protocol violation201
Withdrew: Withdrawal by subject926

Outcome measures

PrimaryPercent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin).
Time frame:
Baseline and Week 6
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin).
Percent changeEzetimibe/SimvastatinDoubling Statin Dose
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin).-23.13 (-25.95 to -20.31)-8.37 (-12.32 to -4.41)
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Statin Dose · Longitudinal data analysis (LDA) · p = <0.001 · Percent change in least-square means: -14.76 · 95% CI -19.61 to -9.91
SecondaryIn Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin
Time frame:
Baseline and Week 6
Reported as:
Least squares mean · Percent change
In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin
Percent changeEzetimibe/SimvastatinDoubling Simvastatin Dose
In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin-21.59 (-25.54 to -17.65)-7.98 (-13.57 to -2.38)
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Simvastatin Dose · Longitudinal data analysis (LDA) · p = <0.001 · Percent change in least square means: -13.62 · 95% CI -20.44 to -6.79
SecondaryIn Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin
Time frame:
Baseline and Week 6
Reported as:
Least squares mean · Percent change
In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin
Percent changeEzetimibe/SimvastatinDoubling Atorvastatin Dose
In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin-24.58 (-28.63 to -20.53)-8.85 (-14.47 to -3.23)
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Atorvastatin Dose · Longitudinal Data Analysis (LDA) · p = <0.001 · Percent change in least squares mean: -15.73 · 95% CI -22.65 to -8.81
SecondaryPercent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin
Time frame:
Baseline and Week 6
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin
Percent changeEzetimibe/SimvastatinRosuvastatin
Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin-23.13 (-25.95 to -20.31)-19.32 (-22.14 to -16.51)
Statistical analysis
  • Ezetimibe/Simvastatin vs Rosuvastatin · Longitudinal Data Analysis · p = 0.060 · Percent change in least squares means: -3.81 · 95% CI -7.78 to 0.17
SecondaryNumber of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
Time frame:
Week 6
Reported as:
Number · participants
Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
participantsEzetimibe/SimvastatinDoubling Statin DoseRosuvastatin
Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)17143134
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Statin Dose · Regression, Logistic · p = <0.001 · Odds ratio (or): 3.9 · 95% CI 2.5 to 6.2
  • Ezetimibe/Simvastatin vs Rosuvastatin · Regression, Logistic · p = <0.001 · Odds ratio (or): 1.9 · 95% CI 1.3 to 2.6
SecondaryIn Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
Time frame:
Week 6
Reported as:
Number · participants
In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
participantsEzetimibe/SimvastatinDoubling Simvastatin Dose
In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)8419
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Simvastatin Dose · Regression, Logistic · p = <0.001 · Odds ratio (or): 4.5 · 95% CI 2.3 to 8.5
SecondaryIn Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
Time frame:
Week 6
Reported as:
Number · participants
In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
participantsEzetimibe/SimvastatinDoubling Atorvastatin Dose
In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)8724
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Atorvastatin Dose · Regression, Logistic · p = <0.001 · Odds ratio (or): 3.5 · 95% CI 1.9 to 6.6
SecondaryPercent Change From Baseline in Total Cholesterol (TC)
Time frame:
Baseline and Week 6
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline in Total Cholesterol (TC)
Percent ChangeEzetimibe/SimvastatinDoubling Statin DoseRosuvastatin
Percent Change From Baseline in Total Cholesterol (TC)-13.21 ± 17.69-4.88 ± 15.14-10.58 ± 15.18
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Statin Dose · Longitudinal data analysis (LDA) · p = <0.001 · Least squares mean difference: -8.33 · 95% CI -11.38 to -5.28
  • Ezetimibe/Simvastatin vs Rosuvastatin · Longitudinal data analysis (LDA) · p = 0.039 · Least squares mean difference: -2.63 · 95% CI -5.13 to -0.13
SecondaryPercent Change From Baseline in Triglycerides
Time frame:
Baseline and Week 6
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Triglycerides
Percent changeEzetimibe/SimvastatinDoubling Statin DoseRosuvastatin
Percent Change From Baseline in Triglycerides-5.51 (-8.75 to -2.15)-2.63 (-7.23 to 2.21)-3.35 (-6.66 to 0.08)
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Statin Dose · Longitudinal data analysis (LDA) · p = 0.316 · Least squares mean difference: -2.88 · 95% CI -8.53 to 2.77
  • Ezetimibe/Simvastatin vs Rosuvastatin · Longitudinal data analysis (LDA) · p = 0.356 · Least squares mean difference: -2.16 · 95% CI -6.75 to 2.43
SecondaryPercent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Time frame:
Baseline and Week 6
Reported as:
Least squares mean · percent change
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
percent changeEzetimibe/SimvastatinDoubling Statin DoseRosuvastatin
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)1.47 (-0.27 to 3.21)1.00 (-1.43 to 3.43)1.99 (0.26 to 3.73)
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Statin Dose · Longitudinal data analysis (LDA) · p = 0.756 · Least squares mean difference: 0.47 · 95% CI -2.50 to 3.45
  • Ezetimibe/Simvastatin vs Rosuvastatin · Longitudinal data analysis (LDA) · p = 0.675 · Least sqares mean difference: -0.52 · 95% CI -2.96 to 1.92
SecondaryPercent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Time frame:
Baseline and Week 6
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Percent changeEzetimibe/SimvastatinDoubling Statin DoseRosuvastatin
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)-18.39 (-20.90 to -15.88)-6.77 (-10.29 to -3.25)-15.14 (-17.72 to -12.70)
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Statin Dose · Longitudinal data analysis (LDA) · p = <0.001 · Least squares mean difference: -11.62 · 95% CI -15.93 to -7.31
  • Ezetimibe/Simvastatin vs Rosuvastatin · Longitudinal data analysis (LDA) · p = 0.078 · Least squares mean difference: -3.18 · 95% CI -6.71 to 0.35
SecondaryPercent Change From Baseline in LDL-C/HDL-C Ratio
Time frame:
Baseline and Week 6
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in LDL-C/HDL-C Ratio
Percent changeEzetimibe/SimvastatinDoubling Statin DoseRosuvastatin
Percent Change From Baseline in LDL-C/HDL-C Ratio-21.55 (-25.09 to -18.01)-7.39 (-12.34 to -2.43)-18.99 (-22.52 to -15.46)
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Statin Dose · Longitudinal data analysis (LDA) · p = <0.001 · Least squares mean difference: -14.16 · 95% CI -20.23 to -8.10
  • Ezetimibe/Simvastatin vs Rosuvastatin · Longitudinal data analysis (LDA) · p = 0.313 · Least sqares mean difference: -2.56 · 95% CI -7.53 to 2.41
SecondaryPercent Change From Baseline in TC/HDL-C Ratio
Time frame:
Baseline and Week 6
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in TC/HDL-C Ratio
Percent changeEzetimibe/SimvastatinDoubling Statin DoseRosuvastatin
Percent Change From Baseline in TC/HDL-C Ratio-12.52 (-14.83 to -10.22)-4.36 (-7.58 to -1.14)-10.70 (-12.99 to -8.40)
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Statin Dose · Longitudinal data analysis (LDA) · p = <0.001 · Least squares mean difference: -8.17 · 95% CI -12.10 to -4.23
  • Ezetimibe/Simvastatin vs Rosuvastatin · Longitudinal data analysis (LDA) · p = 0.266 · Least squares mean difference: -1.83 · 95% CI -5.05 to 1.40
SecondaryPercent Change From Baseline in Non-HDL-C/HDL-C Ratio
Time frame:
Baseline and Week 6
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio
percent changeEzetimibe/SimvastatinDoubling Statin DoseRosuvastatin
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio-16.77 (-20.09 to -13.45)-5.32 (-9.98 to -0.66)-14.64 (-17.95 to -11.32)
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Statin Dose · Longitudinal data analysis (LDA) · p = <0.001 · Least squares mean difference: -11.45 · 95% CI -17.16 to -5.75
  • Ezetimibe/Simvastatin vs Rosuvastatin · Longitudinal data analysis (LDA) · p = 0.371 · Least squares mean difference: -2.13 · 95% CI -6.81 to 2.54
SecondaryPercent Change From Baseline in Apolipoprotein B (Apo B)
Time frame:
Baseline and Week 6
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Apolipoprotein B (Apo B)
Percent changeEzetimibe/SimvastatinDoubling Statin DoseRosuvastatin
Percent Change From Baseline in Apolipoprotein B (Apo B)-14.98 (-16.99 to -12.97)-6.97 (-9.78 to -4.15)-12.03 (-14.05 to -10.02)
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Statin Dose · Longitudinal data analysis (LDA) · p = <0.001 · Least squares mean difference: -8.01 · 95% CI -11.46 to -4.56
  • Ezetimibe/Simvastatin vs Rosuvastatin · Longitudinal data analysis (LDA) · p = 0.041 · Least squares mean difference: -2.95 · 95% CI -5.78 to -0.12
SecondaryPercent Change From Baseline Apolipoprotein A-I (Apo A-I)
Time frame:
Baseline and Week 6
Reported as:
Least squares mean · Percent change
Percent Change From Baseline Apolipoprotein A-I (Apo A-I)
Percent changeEzetimibe/SimvastatinDoubling Statin DoseRosuvastatin
Percent Change From Baseline Apolipoprotein A-I (Apo A-I)0.64 (-0.84 to 2.11)-0.93 (-2.99 to 1.12)0.86 (-0.62 to 2.34)
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Statin Dose · Longitudinal data analysis (LDA) · p = 0.218 · Least squares mean difference: 1.57 · 95% CI -0.93 to 4.06
  • Ezetimibe/Simvastatin vs Rosuvastatin · Longitudinal data analysis (LDA) · p = 0.832 · Least squares mean difference: -0.22 · 95% CI -2.27 to 1.83
SecondaryPercent Change From Baseline in Apo B/Apo A-I Ratio
Time frame:
Baseline and Week 6
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Apo B/Apo A-I Ratio
Percent changeEzetimibe/SimvastatinDoubling Statin DoseRosuvastatin
Percent Change From Baseline in Apo B/Apo A-I Ratio-13.67 (-16.27 to -11.06)-4.75 (-8.39 to -1.11)-11.14 (-13.75 to -8.54)
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Statin Dose · Longitudinal data analysis (LDA) · p = <0.001 · Least squares mean difference: -8.91 · 95% CI -13.36 to -4.47
  • Ezetimibe/Simvastatin vs Rosuvastatin · Longitudinal data analysis (LDA) · p = 0.175 · Least squares mean difference: -2.52 · 95% CI -6.17 to 1.13
SecondaryPercent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)
Time frame:
Baseline and Week 6
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)
Percent changeEzetimibe/SimvastatinDoubling Statin DoseRosuvastatin
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)-4.42 (-13.94 to 6.15)-1.64 (-14.93 to 13.74)-9.11 (-18.13 to 0.92)
Statistical analysis
  • Ezetimibe/Simvastatin vs Doubling Statin Dose · Longitudinal data analysis (LDA) · p = 0.749 · Least squares mean difference: -2.78 · 95% CI -19.88 to 14.32
  • Ezetimibe/Simvastatin vs Rosuvastatin · Longitudinal data analysis (LDA) · p = 0.494 · Least squares mean difference: 4.69 · 95% CI -8.73 to 18.10

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ezetimibe/Simvastatin—2/321 (0.6%)0/321 (0%)
Doubling Statin Dose—1/162 (0.6%)0/162 (0%)
Rosuvastatin—2/323 (0.6%)0/323 (0%)
Most frequent serious events
Most frequent serious events
EventEzetimibe/SimvastatinDoubling Statin DoseRosuvastatin
Myocardial infarctionCardiac disorders0/3211/1620/323
Angina pectorisCardiac disorders1/3210/1620/323
Coronary artery diseaseCardiac disorders1/3210/1620/323
Angina unstableCardiac disorders0/3210/1621/323
Arterial thrombosis limbVascular disorders0/3210/1621/323

Baseline characteristics

Age, Continuous
Age, Continuous(years)Ezetimibe/SimvastatinDoubling Statin DoseRosuvastatinTotal
Mean64.1 ± 8.864.7 ± 8.363.6 ± 8.464.0 ± 8.5
Sex: Female, Male
Sex: Female, Male(Participants)Ezetimibe/SimvastatinDoubling Statin DoseRosuvastatinTotal
Female16282142386
Male16080182422
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Le NA, Tomassini JE, Tershakovec AM, Neff DR, Wilson PW. Effect of Switching From Statin Monotherapy to Ezetimibe/Simvastatin Combination Therapy Compared With Other Intensified Lipid-Lowering Strategies on Lipoprotein Subclasses in Diabetic Patients With Symptomatic Cardiovascular Disease. J Am Heart Assoc. 2015 Oct 20;4(10):e001675. doi: 10.1161/JAHA.114.001675. PubMed 26486166 ↗
  • Rosen JB, Jimenez JG, Pirags V, Vides H, Massaad R, Hanson ME, Brudi P, Triscari J. Consistency of effect of ezetimibe/simvastatin compared with intensified lipid-lowering treatment strategies in obese and non-obese diabetic subjects. Lipids Health Dis. 2013 Jul 16;12:103. doi: 10.1186/1476-511X-12-103. PubMed 23866306 ↗
  • Rosen JB, Jimenez JG, Pirags V, Vides H, Hanson ME, Massaad R, McPeters G, Brudi P, Triscari J. A comparison of efficacy and safety of an ezetimibe/simvastatin combination compared with other intensified lipid-lowering treatment strategies in diabetic patients with symptomatic cardiovascular disease. Diab Vasc Dis Res. 2013 May;10(3):277-86. doi: 10.1177/1479164112465212. Epub 2013 Jan 3. PubMed 23288881 ↗
  • Jimenez JG, Rosen JB, Pirags V, Massaad R, Hanson ME, Brudi P, Triscari J. The efficacy and safety of ezetimibe/simvastatin combination compared with intensified lipid-lowering treatment strategies in diabetic subjects with and without metabolic syndrome. Diabetes Obes Metab. 2013 Jun;15(6):513-22. doi: 10.1111/dom.12059. Epub 2013 Jan 25. PubMed 23279632 ↗

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2009, a primary completion of Mar 2011 and a completion of Mar 2011. It does not say whether these dates are actual or estimated.

Results were first posted in Mar 2012, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2009
First posted
Mar 16, 2009
Start
Apr 2009
Primary completionActual
Mar 2011
CompletionActual
Mar 2011
Results first posted
Mar 16, 2012
Last update
May 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00862251
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Mar 16, 2009
Start date
Apr 2009
Primary completion
Mar 2011
Completion
Mar 2011
Results posted
Mar 16, 2012
Last update
May 16, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Ezetimibe · Simvastatin

Other studies in this condition

Cardiovascular Diseases →

Other studies from this sponsor

Organon and Co →

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