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CompletedNCT00412113TOGETHERUpdated Feb 11, 2021Results posted

A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk

A Phase 4 interventional study of Amlodipine besylate and Amlodipine besylate/atorvastatin calcium single pill combination in Dyslipidemia and Hypertension, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 51 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-02-11.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
245
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.

02

Conditions studied

  • Dyslipidemia
  • Hypertension

Browse trials for

03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 245 is above the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

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

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects with diagnosed hypertension receiving treatment with Norvasc 5 or 10 mg and who also have 3 additional cardiovascular risk factors, including dyslipidemia.

Exclusion criteria

Exclusion Criteria:

  • Subjects who are taking the following prohibited medications within 14 days of screening: lipid-lowering therapy, calcium channel blocker other then Norvasc, >3 antihypertensive agents (including Norvasc)
  • Subjects that have not been on a stable dose of Norvasc for at least 4 weeks
  • Subjects with a history of coronary heart disease, stroke, or Pulmonary Vascular Disease (PVD)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
245 participants (actual)

Study arms

  • Active comparator
    Norvasc 5 mg

    Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks.

    Drug: Amlodipine besylate

  • Experimental
    Caduet 10/20mg

    Blinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo.

    Drug: Amlodipine besylate/atorvastatin calcium single pill combination

  • Active comparator
    Norvasc 10 mg

    Blinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks.

    Drug: Amlodipine besylate

  • Experimental
    Caduet 5/20mg

    Blinded amlodipine/atorvastatin single pill combination 5/20 mg and amlodipine besylate 5 mg placebo dosed once daily for 6 weeks .

    Drug: Amlodipine besylate/atorvastatin calcium single pill combination

Interventions

  • DrugAmlodipine besylate

    Amlodipine besylate 5 mg

  • DrugAmlodipine besylate/atorvastatin calcium single pill combination

    Amlodipine/atorvastatin single pill combination 10/20 mg

  • DrugAmlodipine besylate

    Amlodipine besylate 10 mg

  • DrugAmlodipine besylate/atorvastatin calcium single pill combination

    Amlodipine/atorvastatin single pill combination 5/20 mg

06

What researchers measure

Primary outcomes

  1. Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6

    Number of subjects reaching dual goal of systolic blood pressure \<140 millimeters of mercury (mmHg) and diastolic blood pressue of \<90 mmHg and low density lipoprotein-cholesterol(LDL-C) \<100 milligrams per deciliter(mg/dL)

    Time frame: Week 6

  2. Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk

    Framingham prediction of absolute 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction \[MI\] or CHD death) are calculations based on total point score (range less than negative 3 \[best\] to greater than or equal to 14 \[worst\] for men; less than or equal to negative 2 \[best\] and greater than or equal to 17 \[worst\] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol, and systolic blood pressure calculated at Week 6. Mean at observation minus mean at baseline.

    Time frame: Week 6, baseline

Secondary outcomes

  1. Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4

    Subjects achieving both the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC)-7 blood pressure goal of \<140/90 mmHg and the National Cholesterol Education Program Adult Treatment Panel (NCEP/ATP) III Update low density lipoprotein-cholesterol (LDL-C) goal \<100 mg/dL at Week 4.

    Time frame: Week 4

  2. Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.

    Subjects achieving both JNC-7 blood pressure goal of \<140/90 mmHg and NCEP/ATP III LDL-C goal \<130 mg/dL at Week 4.

    Time frame: Week 4

  3. Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.

    Subjects achieving both JNC-7 blood pressure goal of \<140/90 mmHg and NCEP/ATP III LDL-C goal \<130 mg/dL at Week 6.

    Time frame: Week 6

  4. Subjects With LDL-C < 100 mg/dL at Week 4

    Subjects Who achieve a goal of LDL-C \< 100 mg/dL at Week 4.

    Time frame: Week 4

  5. Subjects With LDL-C < 100 mg/dL at Week 6

    Subjects Who achieve a goal of LDL-C \< 100 mg/dL at Week 6.

    Time frame: Week 6

  6. Subjects With BP < 140/90 mmHg at Week 4

    Subjects achieving BP goal of \<140/90 mmHg at week 4

    Time frame: Week 4

  7. Subjects With BP < 140/90 mmHg at Week 6

    Subjects achieving BP goal of \<140/90 mmHg at week 6

    Time frame: Week 6

  8. Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).

    Mean at observation minus mean at baseline

    Time frame: Week 4, baseline

  9. Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)

    Mean at observation minus mean at baseline

    Time frame: Week 4, baseline

  10. Change From Baseline to Week 4 in Pulse Rate

    Mean at observation minus mean at baseline measured in beats per minute (bpm).

    Time frame: Week 4, baseline

  11. Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)

    Mean change at observation minus mean baseline.

    Time frame: Week 6, baseline

  12. Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)

    Change from mean at observation minus mean at baseline

    Time frame: Week 6, baseline

  13. Change From Baseline to Week 6 in Pulse Rate

    Mean at observation minus mean at baseline

    Time frame: Week 6, baseline

  14. Change From Baseline in LDL at Week 4.

    Change: mean of observation minus mean at baseline.

    Time frame: Week 4, baseline

  15. Change From Baseline in High Density Lipoprotein (HDL) at Week 4.

    Mean change at observation minus baseline.

    Time frame: Week 4, baseline

  16. Change in Total Cholesterol (TC) From Baseline to Week 4.

    Mean change at observation minus baseline.

    Time frame: Week 4, baseline

  17. Change From Baseline in Triglycerides (TG) to Week 4.

    Mean change at observation minus baseline

    Time frame: Week 4, baseline

  18. Change From Baseline in LDL at Week 6.

    Mean change at observation minus baseline.

    Time frame: Week 6, baseline

  19. Change From Baseline in HDL at Week 6.

    Mean change at observation minus baseline.

    Time frame: Week 6, baseline

  20. Change From Baseline in Total Cholesterol (TC) to Week 6.

    Mean change at observation minus baseline.

    Time frame: Week 6, baseline

  21. Change From Baseline in Triglycerides (TG) at Week 6.

    Mean change at observation minus mean baseline.

    Time frame: Week 6 , baseline

  22. Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.

    Framingham prediction of absolute 10-year risk of CHD outcomes (MI or CHD death) are calculations based on total point score (range less than negative 3 \[best\] to greater than or equal to 14 \[worst\] for men; less than or equal to negative 2 \[best\] and greater than or equal to 17 \[worst\] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol and systolic blood pressure calculated at Week 4. Mean at observation minus mean at baseline.

    Time frame: Week 4, baseline

07

Results

Posted Nov 6, 2009

Participant flow

Participant flow — Overall Study
MilestoneNorvasc + TLCCaduet + TLC
Started123122
Received treatment122122
Completed111107
Not completed1215
Withdrew: Adverse event1115
Withdrew: Did not receive treatment10

Outcome measures

PrimarySubjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6

Number of subjects reaching dual goal of systolic blood pressure \<140 millimeters of mercury (mmHg) and diastolic blood pressue of \<90 mmHg and low density lipoprotein-cholesterol(LDL-C) \<100 milligrams per deciliter(mg/dL)

Time frame:
Week 6
Reported as:
Number · participants
Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6
participantsNorvasc + TLCCaduet + TLC
Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 61180
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · Cochran-Mantel-Haenszel · p = <0.001 (There was only one primary endpoint and the p-value was not adjusted for comparison.) · Odds ratio (or): 19.03 · 95% CI 9.14 to 39.63
SecondarySubjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4

Subjects achieving both the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC)-7 blood pressure goal of \<140/90 mmHg and the National Cholesterol Education Program Adult Treatment Panel (NCEP/ATP) III Update low density lipoprotein-cholesterol (LDL-C) goal \<100 mg/dL at Week 4.

Time frame:
Week 4
Reported as:
Number · participants
Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4
participantsNorvasc + TLCCaduet + TLC
Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4673
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · Cochran-Mantel-Haenszel · p = <0.001 (No adjustment for p-value for secondary analysis) · Odds ratio (or): 31.39 · 95% CI 12.61 to 78.09
SecondarySubjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.

Subjects achieving both JNC-7 blood pressure goal of \<140/90 mmHg and NCEP/ATP III LDL-C goal \<130 mg/dL at Week 4.

Time frame:
Week 4
Reported as:
Number · participants
Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.
participantsNorvasc + TLCCaduet + TLC
Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.4185
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · Cochran-Mantel-Haenszel · p = <0.001 (No adjustment for p-value for secondary analyses) · Odds ratio (or): 5.2 · 95% CI 2.93 to 9.24
SecondarySubjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.

Subjects achieving both JNC-7 blood pressure goal of \<140/90 mmHg and NCEP/ATP III LDL-C goal \<130 mg/dL at Week 6.

Time frame:
Week 6
Reported as:
Number · participants
Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.
participantsNorvasc + TLCCaduet + TLC
Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.4590
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · Cochran-Mantel-Haenszel · p = <0.001 (No adjustment for p-value for secondary analyses) · Odds ratio (or): 5.14 · 95% CI 2.89 to 9.11
SecondarySubjects With LDL-C < 100 mg/dL at Week 4

Subjects Who achieve a goal of LDL-C \< 100 mg/dL at Week 4.

Time frame:
Week 4
Reported as:
Number · participants
Subjects With LDL-C < 100 mg/dL at Week 4
participantsNorvasc + TLCCaduet + TLC
Subjects With LDL-C < 100 mg/dL at Week 4896
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · Cochran-Mantel-Haenszel · p = <0.001 (No adjustment for p-value for secondary analyses) · Odds ratio (or): 65.51 · 95% CI 27.10 to 158.34
SecondarySubjects With LDL-C < 100 mg/dL at Week 6

Subjects Who achieve a goal of LDL-C \< 100 mg/dL at Week 6.

Time frame:
Week 6
Reported as:
Number · participants
Subjects With LDL-C < 100 mg/dL at Week 6
participantsNorvasc + TLCCaduet + TLC
Subjects With LDL-C < 100 mg/dL at Week 61399
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · Cochran-Mantel-Haenszel · p = <0.001 (No adjustment for p-value for secondary analyses) · Odds ratio (or): 42.04 · 95% CI 19.42 to 90.99
SecondarySubjects With BP < 140/90 mmHg at Week 4

Subjects achieving BP goal of \<140/90 mmHg at week 4

Time frame:
Week 4
Reported as:
Number · participants
Subjects With BP < 140/90 mmHg at Week 4
participantsNorvasc + TLCCaduet + TLC
Subjects With BP < 140/90 mmHg at Week 48487
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · Cochran-Mantel-Haenszel · p = 0.785 (No adjustment for p-value for secondary analyses) · Odds ratio (or): 1.09 · 95% CI 0.60 to 1.98
SecondarySubjects With BP < 140/90 mmHg at Week 6

Subjects achieving BP goal of \<140/90 mmHg at week 6

Time frame:
Week 6
Reported as:
Number · participants
Subjects With BP < 140/90 mmHg at Week 6
participantsNorvasc + TLCCaduet + TLC
Subjects With BP < 140/90 mmHg at Week 68394
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · Cochran-Mantel-Haenszel · p = 0.171 (No adjustment for p-value for secondary analyses) · Odds ratio (or): 1.55 · 95% CI 0.83 to 2.88
SecondaryChange From Baseline to Week 4 in Systolic Blood Pressure (SBP).

Mean at observation minus mean at baseline

Time frame:
Week 4, baseline
Reported as:
Mean · mmHg
Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).
mmHgNorvasc + TLCCaduet + TLC
Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).-2.6 ± 12.1-1.5 ± 11.9
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = 0.585 (No adjustment for p-value for secondary analyses) · Difference in ls means: 0.76 · 95% CI -1.97 to 3.48
SecondaryChange From Baseline to Week 4 in Diastolic Blood Pressure (DBP)

Mean at observation minus mean at baseline

Time frame:
Week 4, baseline
Reported as:
Mean · mmHg
Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)
mmHgNorvasc + TLCCaduet + TLC
Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)-1.5 ± 7.7-1.2 ± 8.8
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = > 0.999 (No adjustment for p-value for secondary analyses) · Difference in ls means: -0.00 · 95% CI -2.01 to 2.01
SecondaryChange From Baseline to Week 4 in Pulse Rate

Mean at observation minus mean at baseline measured in beats per minute (bpm).

Time frame:
Week 4, baseline
Reported as:
Mean · bpm
Change From Baseline to Week 4 in Pulse Rate
bpmNorvasc + TLCCaduet + TLC
Change From Baseline to Week 4 in Pulse Rate-0.1 ± 8.2-0.9 ± 8.5
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = 0.363 · Difference in ls means: -0.90 · 95% CI -2.83 to 1.04
SecondaryChange From Baseline to Week 6 in Systolic Blood Pressure (SBP)

Mean change at observation minus mean baseline.

Time frame:
Week 6, baseline
Reported as:
Mean · mmHg
Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)
mmHgNorvasc + TLCCaduet + TLC
Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)-1.0 ± 12.6-4.0 ± 11.0
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = 0.020 (No adjustment for p-value for secondary analyses) · Difference in ls means: -3.25 · 95% CI -5.99 to -0.51
SecondaryChange From Baseline to Week 6 in Diastolic Blood Pressue (DBP)

Change from mean at observation minus mean at baseline

Time frame:
Week 6, baseline
Reported as:
Median · mmHg
Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)
mmHgNorvasc + TLCCaduet + TLC
Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)-1.1 ± 7.1-1.7 ± 8.2
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = 0.351 (No adjustment for p-value for secondary analyses) · Difference in ls means: -0.87 · 95% CI -2.71 to 0.97
SecondaryChange From Baseline to Week 6 in Pulse Rate

Mean at observation minus mean at baseline

Time frame:
Week 6, baseline
Reported as:
Mean · bpm
Change From Baseline to Week 6 in Pulse Rate
bpmNorvasc + TLCCaduet + TLC
Change From Baseline to Week 6 in Pulse Rate0.9 ± 8.11.1 ± 9.0
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = 0.922 (No adjustment for p-value for secondary analyses) · Difference in ls means: 0.10 · 95% CI -1.91 to 2.11
SecondaryChange From Baseline in LDL at Week 4.

Change: mean of observation minus mean at baseline.

Time frame:
Week 4, baseline
Reported as:
Mean · mg/dL
Change From Baseline in LDL at Week 4.
mg/dLNorvasc + TLCCaduet + TLC
Change From Baseline in LDL at Week 4.-0.5 ± 23.0-47.8 ± 24.4
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = <0.001 (No adjustment for p-value for secondary analyses) · Difference in ls means: -49.30 · 95% CI -54.68 to -43.91
SecondaryChange From Baseline in High Density Lipoprotein (HDL) at Week 4.

Mean change at observation minus baseline.

Time frame:
Week 4, baseline
Reported as:
Mean · mg/dL
Change From Baseline in High Density Lipoprotein (HDL) at Week 4.
mg/dLNorvasc + TLCCaduet + TLC
Change From Baseline in High Density Lipoprotein (HDL) at Week 4.0.6 ± 5.80.6 ± 8.6
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = 0.739 (No adjustment for p-value for secondary analyses) · Difference in ls means: -0.30 · 95% CI -2.07 to 1.47
SecondaryChange in Total Cholesterol (TC) From Baseline to Week 4.

Mean change at observation minus baseline.

Time frame:
Week 4, baseline
Reported as:
Mean · mg/dL
Change in Total Cholesterol (TC) From Baseline to Week 4.
mg/dLNorvasc + TLCCaduet + TLC
Change in Total Cholesterol (TC) From Baseline to Week 4.0.5 ± 23.5-55.9 ± 26.8
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = <0.001 (No adjustment for p-value for secondary analyses) · Difference in ls means: -57.9 · 95% CI -64.02 to 51.81
SecondaryChange From Baseline in Triglycerides (TG) to Week 4.

Mean change at observation minus baseline

Time frame:
Week 4, baseline
Reported as:
Mean · mg/dL
Change From Baseline in Triglycerides (TG) to Week 4.
mg/dLNorvasc + TLCCaduet + TLC
Change From Baseline in Triglycerides (TG) to Week 4.2.4 ± 73.2-45.7 ± 62.8
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = <0.001 (No adjustment for p-value for secondary analyses) · Difference in ls means: -47.27 · 95% CI -63.37 to -31.16
SecondaryChange From Baseline in LDL at Week 6.

Mean change at observation minus baseline.

Time frame:
Week 6, baseline
Reported as:
Mean · mg/dL
Change From Baseline in LDL at Week 6.
mg/dLNorvasc + TLCCaduet + TLC
Change From Baseline in LDL at Week 6.0.3 ± 24.8-49.2 ± 24.0
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = <0.001 (No adjustment for p-value for secondary analyses) · Difference in ls means: -51.21 · 95% CI -56.88 to -45.55
SecondaryChange From Baseline in HDL at Week 6.

Mean change at observation minus baseline.

Time frame:
Week 6, baseline
Reported as:
Mean · mg/dL
Change From Baseline in HDL at Week 6.
mg/dLNorvasc + TLCCaduet + TLC
Change From Baseline in HDL at Week 6.1.2 ± 8.20.4 ± 8.2
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = 0.329 (No adjustment for p-value for secondary analyses) · Difference in ls means: -1.02 · 95% CI -3.07 to 1.03
SecondaryChange From Baseline in Total Cholesterol (TC) to Week 6.

Mean change at observation minus baseline.

Time frame:
Week 6, baseline
Reported as:
Mean · mg/dL
Change From Baseline in Total Cholesterol (TC) to Week 6.
mg/dLNorvasc + TLCCaduet + TLC
Change From Baseline in Total Cholesterol (TC) to Week 6.3.7 ± 23.8-56.8 ± 28.4
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = <0.001 (No adjustment for p-value for secondary analyses) · Difference in ls means: -62.07 · 95% CI -68.49 to -55.65
SecondaryChange From Baseline in Triglycerides (TG) at Week 6.

Mean change at observation minus mean baseline.

Time frame:
Week 6 , baseline
Reported as:
Mean · mg/dL
Change From Baseline in Triglycerides (TG) at Week 6.
mg/dLNorvasc + TLCCaduet + TLC
Change From Baseline in Triglycerides (TG) at Week 6.11.6 ± 115.3-42.6 ± 67.3
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = <0.001 (No adjustment for p-value for secondary analyses) · Difference in ls means: -53.95 · 95% CI -77.61 to -30.29
SecondaryChange From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.

Framingham prediction of absolute 10-year risk of CHD outcomes (MI or CHD death) are calculations based on total point score (range less than negative 3 \[best\] to greater than or equal to 14 \[worst\] for men; less than or equal to negative 2 \[best\] and greater than or equal to 17 \[worst\] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol and systolic blood pressure calculated at Week 4. Mean at observation minus mean at baseline.

Time frame:
Week 4, baseline
Reported as:
Least squares mean · score on scale
Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.
score on scaleNorvasc + TLCCaduet + TLC
Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.-0.3 ± 2.5-2.8 ± 3.3
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = <0.001 (No adjustment for p-value for secondary analyses) · Difference in ls means: -2.4 · 95% CI -3.1 to -1.7
PrimaryChange From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk

Framingham prediction of absolute 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction \[MI\] or CHD death) are calculations based on total point score (range less than negative 3 \[best\] to greater than or equal to 14 \[worst\] for men; less than or equal to negative 2 \[best\] and greater than or equal to 17 \[worst\] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol, and systolic blood pressure calculated at Week 6. Mean at observation minus mean at baseline.

Time frame:
Week 6, baseline
Reported as:
Least squares mean · score on scale
Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk
score on scaleNorvasc + TLCCaduet + TLC
Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk-0.1 ± 2.9-2.9 ± 3.0
Statistical analysis
  • Norvasc + TLC vs Caduet + TLC · ANCOVA · p = <0.001 (No adjustment for p-value for secondary analyses) · Difference in ls means: -2.8 · 95% CI -3.5 to -2.1

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Norvasc + TLC—0/122 (0%)16/122 (13.1%)
Caduet + TLC—0/122 (0%)7/122 (5.7%)
Most frequent other events
Most frequent other events
EventNorvasc + TLCCaduet + TLC
Oedema peripheralGeneral disorders8/1223/122
HypertensionVascular disorders5/1223/122
Urinary tract infectionInfections and infestations3/1221/122

Baseline characteristics

Age, Customized
Age, Customized(participants)Norvasc + TLCCaduet + TLCTotal
18 to 64 years9597192
> or = to 65 years272552
Sex: Female, Male
Sex: Female, Male(Participants)Norvasc + TLCCaduet + TLCTotal
Female5665121
Male6657123
08

Study locations

51 sites
  • Pfizer Investigational Site
    Birmingham, Alabama 35209, United States
  • Pfizer Investigational Site
    Birmingham, Alabama 35216, United States
  • Pfizer Investigational Site
    Birmingham, Alabama 35234, United States
  • Pfizer Investigational Site
    Mesa, Arizona 85206, United States
  • Pfizer Investigational Site
    Garden Grove, California 92843, United States
  • Pfizer Investigational Site
    Mission Viejo, California 92692, United States
  • Pfizer Investigational Site
    Rancho Santa Margarita, California 92688, United States
  • Pfizer Investigational Site
    Torrance, California 90502, United States
  • Pfizer Investigational Site
    Gainesville, Florida 32605, United States
  • Pfizer Investigational Site
    Kissimmee, Florida 34741, United States
  • Pfizer Investigational Site
    Melbourne, Florida 32935, United States
  • Pfizer Investigational Site
    Miami, Florida 33176, United States
  • Pfizer Investigational Site
    Safety Harbor, Florida 34695, United States
  • Pfizer Investigational Site
    Saint Petersburg, Florida 33701, United States
  • Pfizer Investigational Site
    Augusta, Georgia 30904, United States
  • Pfizer Investigational Site
    Tucker, Georgia 30084, United States
  • Pfizer Investigational Site
    South Bend, Indiana 46601, United States
  • Pfizer Investigational Site
    Erlanger, Kentucky 41018, United States
  • Pfizer Investigational Site
    Auburn, Maine 04210, United States
  • Pfizer Investigational Site
    Warren, Michigan 48091, United States
  • Pfizer Investigational Site
    Minneapolis, Minnesota 55404, United States
  • Pfizer Investigational Site
    Chesterfield, Missouri 63017, United States
  • Pfizer Investigational Site
    Florissant, Missouri 63031, United States
  • Pfizer Investigational Site
    Omaha, Nebraska 68116-2004, United States
  • Pfizer Investigational Site
    Henderson, Nevada 89014, United States
  • Pfizer Investigational Site
    Henderson, Nevada 89015, United States
  • Pfizer Investigational Site
    Belvidere, New Jersey 07823, United States
  • Pfizer Investigational Site
    Bridgewater, New Jersey 08807, United States
  • Pfizer Investigational Site
    Clifton, New Jersey 07013, United States
  • Pfizer Investigational Site
    Elizabeth, New Jersey 07202, United States
  • Pfizer Investigational Site
    Hillsborough, New Jersey 08844, United States
  • Pfizer Investigational Site
    Trenton, New Jersey 08618, United States
  • Pfizer Investigational Site
    Brooklyn, New York 11229, United States
  • Pfizer Investigational Site
    Buffalo, New York 14209, United States
  • Pfizer Investigational Site
    Cincinnati, Ohio 45219, United States
  • Pfizer Investigational Site
    Cincinnati, Ohio 45242, United States
  • Pfizer Investigational Site
    Oklahoma City, Oklahoma 73103, United States
  • Pfizer Investigational Site
    Tulsa, Oklahoma 74136, United States
  • Pfizer Investigational Site
    Bensalem, Pennsylvania 19020, United States
  • Pfizer Investigational Site
    Lansdale, Pennsylvania 19446, United States
  • Pfizer Investigational Site
    Philadelphia, Pennsylvania 19146, United States
  • Pfizer Investigational Site
    Providence, Rhode Island 02904, United States
  • Pfizer Investigational Site
    Goose Creek, South Carolina 29445, United States
  • Pfizer Investigational Site
    Mount Pleasant, South Carolina 29464, United States
  • Pfizer Investigational Site
    Bristol, Tennessee 37620, United States
  • Pfizer Investigational Site
    Kingsport, Tennessee 37660, United States
  • Pfizer Investigational Site
    Dallas, Texas 75235, United States
  • Pfizer Investigational Site
    Houston, Texas 77030-2324, United States
  • Pfizer Investigational Site
    Plano, Texas 75093, United States
  • Pfizer Investigational Site
    San Antonio, Texas 78238, United States
  • Pfizer Investigational Site
    Chesapeake, Virginia 23320, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00412113
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
First posted
Dec 15, 2006
Start date
Jan 2007
Primary completion
Apr 2008
Completion
Apr 2008
Results posted
Nov 6, 2009
Last update
Feb 11, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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