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CompletedNCT00409773Updated May 16, 2024Results posted

Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

A Phase 3 interventional study of ezetimibe (+) simvastatin and Comparator: atorvastatin calcium in Hypercholesterolemia and Metabolic Syndrome, 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
1,143
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study summary

A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.

02

Conditions studied

  • Hypercholesterolemia
  • Metabolic Syndrome
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 1,143 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

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

Inclusion criteria

  • Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category

Exclusion criteria

Exclusion Criteria:

  • A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study
  • Patient is likely to be greater than 20% noncompliant in taking study medications
  • Patients with chronic medical conditions
  • Patients with unstable doses of medications
  • Pregnant or lactating women, women intending to become pregnant
  • Patient is currently receiving prescription therapy with statins or other lipid-altering medications
  • Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,143 participants (actual)

Study arms

  • Other
    1

    Arm 1: drug + comparator + Placebo

    Drug: ezetimibe (+) simvastatin · Drug: Comparator: atorvastatin calcium · Drug: Comparator: Placebo (unspecified)

  • Other
    2

    Arm 2: drug + comparator + Placebo

    Drug: ezetimibe (+) simvastatin · Drug: Comparator: atorvastatin calcium · Drug: Comparator: Placebo (unspecified)

  • Other
    3

    Arm 3: drug + comparator + Placebo

    Drug: ezetimibe (+) simvastatin · Drug: Comparator: atorvastatin calcium · Drug: Comparator: Placebo (unspecified)

  • Other
    4

    Arm 4: drug + comparator + Placebo

    Drug: ezetimibe (+) simvastatin · Drug: Comparator: atorvastatin calcium · Drug: Comparator: Placebo (unspecified)

  • Other
    5

    Arm 5: drug + comparator + Placebo

    Drug: ezetimibe (+) simvastatin · Drug: Comparator: atorvastatin calcium · Drug: Comparator: Placebo (unspecified)

Interventions

  • Drugezetimibe (+) simvastatin

    Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.

    Also known as: MK0653A, Vytorin®

  • DrugComparator: atorvastatin calcium

    Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose \& 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.

    Also known as: Lipitor ®

  • DrugComparator: Placebo (unspecified)

    Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose \& 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6

    Time frame: Baseline and 6 Weeks

Secondary outcomes

  1. Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6

    Time frame: Baseline and 6 Weeks

  2. Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6

    Time frame: Baseline and 6 Weeks

  3. Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6

    Time frame: Baseline and 6 Weeks

  4. Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6

    Time frame: Baseline and 6 Weeks

  5. Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6

    Time frame: Baseline and 6 Weeks

  6. Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6

    Time frame: Baseline and 6 Weeks

  7. Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6

    Time frame: Baseline and 6 Weeks

  8. Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6

    Time frame: Baseline and 6 Weeks

  9. Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6

    Time frame: Baseline and 6 Weeks

  10. Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6

    Time frame: Baseline and 6 weeks

  11. Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6

    Time frame: Baseline and 6 Weeks

  12. Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)

    Time frame: Baseline and 6 Weeks

  13. Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)

    Time frame: Baseline and 6 Weeks

  14. Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6

    Time frame: Baseline and 6 Weeks

07

Results

Posted Aug 4, 2009
Limitations and caveats
15 patients were randomized but not treated. Since these patients were not treated no Adverse Event Data was collected.

Participant flow

Phase III First Patient In 06-Feb-2007:; Last Patient Last Visit 16-Jul-2008 110 centers worldwide (International, 12 countries) Eligible patients include drug-naïve patients or patients rendered naïve with the appropriate prior washout at moderately high or high risk for coronary heart disease.

Participant flow — Overall Study
MilestoneAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Started229229229228228
Completed220222220216218
Not completed9791210
Withdrew: Adverse event34426
Withdrew: Lost to follow-up61231
Withdrew: Physician decision00020
Withdrew: Protocol violation02331
Withdrew: Withdrawal by subject00021
Withdrew: Lack of eligibility00001

Outcome measures

PrimaryPercent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6
Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6
Percent ChangeAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6-36.5 (-38.9 to -34.0)-49.6 (-52.0 to -47.2)-39.4 (-41.8 to -36.9)-53.9 (-56.4 to -51.5)-46.0 (-48.4 to -43.6)
Statistical analysis
  • Atorva 10 mg vs EZ/Simva 10 mg/20 mg · ANOVA · p = <0.001 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Mean difference (final values): -13.1 · 95% CI -16.5 to -9.8ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/20 mg vs Atorva 20mg · ANOVA · p = <0.001 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Mean difference (final values): -10.2 · 95% CI -13.6 to -6.9ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/40 mg vs Atorva 40 mg · ANOVA · p = <0.001 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Mean difference (final values): -8.0 · 95% CI -11.3 to -4.6ANOVA with terms for treatment and baseline risk stratum
SecondaryPercent Change From Baseline in Total Cholesterol(mg/dL) at Week 6
Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6
Percent ChangeAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6-26.5 (-28.2 to -24.7)-33.7 (-35.4 to -31.9)-28.3 (-30.1 to -26.6)-37.3 (-39.0 to -35.5)-32.8 (-34.6 to -31.1)
Statistical analysis
  • Atorva 10 mg vs EZ/Simva 10 mg/20 mg · ANOVA · p = <0.001 · Mean difference (final values): -7.2 · 95% CI -9.6 to -4.8ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/20 mg vs Atorva 20mg · ANOVA · p = <0.001 · Mean difference (final values): -5.4 · 95% CI -7.8 to -2.9ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/40 mg vs Atorva 40 mg · ANOVA · p = <0.001 · Mean difference (final values): -4.4 · 95% CI -6.8 to -2.0ANOVA with terms for treatment and baseline risk stratum
SecondaryPercent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6
Time frame:
Baseline and 6 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6
Percent ChangeAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6-21.7 (-25.0 to -17.9)-23.3 (-26.9 to -18.2)-27.5 (-30.8 to -22.4)-29.5 (-32.5 to -25.0)-30.0 (-34.2 to -26.5)
Statistical analysis
  • Atorva 10 mg vs EZ/Simva 10 mg/20 mg · Non-parametric ANOVA · p = 0.690 · Mean difference (final values): -0.9 · 95% CI -5.4 to 3.3ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/20 mg vs Atorva 20mg · Non-parametric ANOVA · p = 0.200 · Median difference (final values): 2.8 · 95% CI -1.6 to 7.1ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/40 mg vs Atorva 40 mg · Non-parametric ANOVA · p = 0.480 · Median difference (final values): -0.4 · 95% CI -4.7 to 3.9ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum
SecondaryPercent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6
Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6
Percent ChangeAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 63.4 (1.5 to 5.3)6.8 (4.9 to 8.7)5.6 (3.7 to 7.5)8.8 (6.9 to 10.7)4.9 (3.0 to 6.8)
Statistical analysis
  • Atorva 10 mg vs EZ/Simva 10 mg/20 mg · ANOVA · p = 0.013 · Mean difference (final values): 3.4 · 95% CI 0.7 to 6.0ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/20 mg vs Atorva 20mg · ANOVA · p = 0.378 · Mean difference (final values): 1.2 · 95% CI -1.5 to 3.8ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/40 mg vs Atorva 40 mg · ANOVA · p = 0.003 · Mean difference (final values): 4.0 · 95% CI 1.3 to 6.6ANOVA with terms for treatment and baseline risk stratum
SecondaryPercent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
Percent ChangeAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6-33.5 (-35.6 to -31.3)-43.8 (-45.9 to -41.7)-36.5 (-38.6 to -34.4)-48.3 (-50.5 to -46.2)-41.4 (-43.6 to -39.3)
Statistical analysis
  • Atorva 10 mg vs EZ/Simva 10 mg/20 mg · ANOVA · p = <0.001 · Mean difference (final values): -10.3 · 95% CI -13.3 to -7.3ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/20 mg vs Atorva 20mg · ANOVA · p = <0.001 · Mean difference (final values): -7.3 · 95% CI -10.2 to -4.3ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/40 mg vs Atorva 40 mg · ANOVA · p = <0.001 · Mean difference (final values): -6.9 · 95% CI -9.9 to -3.9ANOVA with terms for treatment and baseline risk stratum
SecondaryPercent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6
Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6
Percent ChangeAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6-17.7 (-21.4 to -14.0)-18.3 (-22.0 to -14.7)-21.6 (-25.3 to -17.8)-23.4 (-27.1 to -19.7)-22.7 (-26.4 to -19.0)
Statistical analysis
  • Atorva 10 mg vs EZ/Simva 10 mg/20 mg · ANOVA · p = 0.809 · Mean difference (final values): -0.6 · 95% CI -5.7 to 4.5ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/20 mg vs Atorva 20mg · ANOVA · p = 0.217 · Mean difference (final values): 3.2 · 95% CI -1.9 to 8.4ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/40 mg vs Atorva 40 mg · ANOVA · p = 0.796 · Mean difference (final values): -0.7 · 95% CI -5.8 to 4.4ANOVA with terms for treatment and baseline risk stratum
SecondaryPercent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6
Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6
Percent ChangeAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6-27.9 (-29.9 to -25.9)-37.2 (-39.2 to -35.3)-31.9 (-33.9 to -29.9)-41.1 (-43.1 to -39.1)-35.8 (-37.8 to -33.8)
Statistical analysis
  • Atorva 10 mg vs EZ/Simva 10 mg/20 mg · ANOVA · p = <0.001 · Mean difference (final values): -9.4 · 95% CI -12.1 to -6.6ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/20 mg vs Atorva 20mg · ANOVA · p = <0.001 · Mean difference (final values): -5.3 · 95% CI -8.1 to -2.6ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/40 mg vs Atorva 40 mg · ANOVA · p = <0.001 · Mean difference (final values): -5.3 · 95% CI -8.0 to -2.5ANOVA with terms for treatment and baseline risk stratum
SecondaryPercent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6
Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6
Percent ChangeAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 60.8 (-1.0 to 2.5)3.2 (1.5 to 4.9)1.0 (-0.7 to 2.7)3.0 (1.3 to 4.7)1.4 (-0.3 to 3.1)
Statistical analysis
  • Atorva 10 mg vs EZ/Simva 10 mg/20 mg · ANOVA · p = 0.042 · Mean difference (final values): 2.4 · 95% CI 0.1 to 4.8ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/20 mg vs Atorva 20mg · ANOVA · p = <0.001 · Mean difference (final values): 2.2 · 95% CI -0.2 to 4.5ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/40 mg vs Atorva 40 mg · ANOVA · p = <0.001 · Mean difference (final values): 1.6 · 95% CI -7.0 to 4.0ANOVA with terms for treatment and baseline risk stratum
SecondaryPercent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6
Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6
Percent ChangeAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6-28.1 (-30.1 to -26.0)-36.9 (-38.9 to -34.8)-31.5 (-33.6 to -29.5)-41.2 (-43.2 to -39.1)-35.3 (-37.3 to -33.2)
Statistical analysis
  • Atorva 10 mg vs EZ/Simva 10 mg/20 mg · ANOVA · p = <0.001 · Mean difference (final values): -8.8 · 95% CI -11.6 to -6.0ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/20 mg vs Atorva 20mg · ANOVA · p = <0.001 · Mean difference (final values): -5.3 · 95% CI -8.2 to -2.5ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/40 mg vs Atorva 40 mg · ANOVA · p = <0.001 · Mean difference (final values): -5.9 · 95% CI -8.7 to -3.1ANOVA with terms for treatment and baseline risk stratum
SecondaryPercent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6
Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6
Percent ChangeAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6-37.8 (-40.3 to -35.2)-51.8 (-54.3 to -49.3)-42.1 (-44.7 to -39.6)-56.6 (-59.2 to -54.1)-48.2 (-50.7 to -45.6)
Statistical analysis
  • Atorva 10 mg vs EZ/Simva 10 mg/20 mg · ANOVA · p = <0.001 · Mean difference (final values): -14.0 · 95% CI -17.6 to -10.5ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/20 mg vs Atorva 20mg · ANOVA · p = <0.001 · Mean difference (final values): -9.7 · 95% CI -13.2 to -6.1ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/40 mg vs Atorva 40 mg · ANOVA · p = <0.001 · Mean difference (final values): -8.5 · 95% CI -12.0 to -4.9ANOVA with terms for treatment and baseline risk stratum
SecondaryPercent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6
Time frame:
Baseline and 6 weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6
Percent ChangeAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6-27.4 (-29.6 to -25.2)-38.4 (-40.6 to -36.2)-32.0 (-34.2 to -29.8)-41.9 (-44.1 to -39.7)-36.2 (-38.4 to -34.0)
Statistical analysis
  • Atorva 10 mg vs EZ/Simva 10 mg/20 mg · ANOVA · p = <0.001 · Mean difference (final values): -11.0 · 95% CI -14.0 to -8.0ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/20 mg vs Atorva 20mg · ANOVA · p = <0.001 · Mean difference (final values): -6.4 · 95% CI -9.4 to -3.3ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/40 mg vs Atorva 40 mg · ANOVA · p = <0.001 · Mean difference (final values): -5.7 · 95% CI -8.7 to -2.7ANOVA with terms for treatment and baseline risk stratum
SecondaryPercent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6
Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6
Percent ChangeAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6-34.7 (-37.2 to -32.2)-46.2 (-48.6 to -43.7)-39.2 (-41.7 to -36.7)-51.2 (-53.7 to -48.7)-43.5 (-46.0 to -41.0)
Statistical analysis
  • Atorva 10 mg vs EZ/Simva 10 mg/20 mg · ANOVA · p = <0.001 · Mean difference (final values): -11.5 · 95% CI -15.0 to -8.1ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/20 mg vs Atorva 20mg · ANOVA · p = <0.001 · Mean difference (final values): -7.0 · 95% CI -10.4 to -3.6ANOVA with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/40 mg vs Atorva 40 mg · ANOVA · p = <0.001 · Mean difference (final values): -7.7 · 95% CI -11.2 to -4.3ANOVA with terms for treatment and baseline risk stratum
SecondaryPercent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)
Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)
Percent ChangeAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)-37.1 (-41.4 to -32.7)-48.7 (-52.8 to -44.6)-36.9 (-41.5 to -32.4)-56.1 (-60.6 to -51.7)-45.8 (-50.2 to -41.5)
SecondaryPercent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)
Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)
Percent ChangeAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)-36.3 (-39.1 to -33.5)-50.1 (-52.9 to -47.2)-40.3 (-43.1 to -37.6)-53.2 (-55.9 to -50.4)-46.1 (-48.9 to -43.3)
SecondaryPercent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6
Time frame:
Baseline and 6 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6
Percent ChangeAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6-16.8 (-21.7 to -10.6)-17.2 (-24.1 to -12.5)-22.4 (-26.1 to -14.6)-27.6 (-33.3 to -21.4)-30.0 (-33.3 to -25.0)
Statistical analysis
  • Atorva 10 mg vs EZ/Simva 10 mg/20 mg · Non-parametric ANOVA · p = 0.420 · Median difference (final values): -2.9 · 95% CI -11.0 to 5.0ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/20 mg vs Atorva 20mg · Non-parametric ANOVA · p = 0.555 · Median difference (final values): -0.9 · 95% CI -9.5 to 7.2ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum
  • EZ/Simva 10 mg/40 mg vs Atorva 40 mg · Non-parametric ANOVA · p = 0.410 · Median difference (final values): 2.3 · 95% CI -5.1 to 9.6ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Atorva 10 mg———
EZ/Simva 10 mg/20 mg———
Atorva 20mg———
EZ/Simva 10 mg/40 mg———
Atorva 40 mg———
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Atrioventricular Block Second DegreeCardiac disorders0/2280/2260/2261/2240/224
TachyarrhythmiaCardiac disorders0/2280/2260/2260/2241/224
CholestasisHepatobiliary disorders0/2280/2260/2260/2241/224
Prostate CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2280/2260/2260/2241/224
Cerebrovascular AccidentNervous system disorders0/2280/2260/2260/2241/224
Sick Sinus SyndromeCardiac disorders0/2280/2261/2260/2240/224
Urinary Tract InfectionInfections and infestations0/2280/2261/2260/2240/224
Acute Myocardial InfarctionCardiac disorders1/2280/2260/2260/2240/224
Atrial FibrillationCardiac disorders1/2280/2260/2260/2240/224
HeadacheNervous system disorders1/2280/2260/2260/2240/224
Most frequent other events
Showing 10 of 19
Most frequent other events
EventAtorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mg
Any Musculoskeletal And Connective Tissue DisordersMusculoskeletal and connective tissue disorders8/2287/2269/2265/2247/224
Any Gastrointestinal DisordersGastrointestinal disorders7/2286/2267/2264/2242/224
DiarrhoeaGastrointestinal disorders5/2281/2263/2261/2241/224
Any Nervous System DisordersNervous system disorders4/2282/2264/2263/2242/224
HeadacheNervous system disorders4/2280/2264/2260/2242/224
Back PainMusculoskeletal and connective tissue disorders0/2282/2260/2263/2242/224
MyalgiaMusculoskeletal and connective tissue disorders3/2282/2263/2260/2243/224
DizzinessNervous system disorders0/2282/2260/2263/2240/224
Abdominal TendernessGastrointestinal disorders1/2282/2263/2261/2240/224
NauseaGastrointestinal disorders1/2283/2261/2262/2241/224

Baseline characteristics

Age, Continuous
Age, Continuous(years)Atorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mgTotal
Mean59.7 (31 to 79)59.7 (32 to 78)58.2 (33 to 78)59.5 (28 to 80)58.4 (28 to 79)59.1 (28 to 80)
Sex: Female, Male
Sex: Female, Male(Participants)Atorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mgTotal
Female9787106104104498
Male132142123124124645
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Atorva 10 mgEZ/Simva 10 mg/20 mgAtorva 20mgEZ/Simva 10 mg/40 mgAtorva 40 mgTotal
Asian171515182186
Black131818121475
Other2727192726126
White172169177171167856
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Rosen JB, Ballantyne CM, Hsueh WA, Lin J, Shah AK, Lowe RS, Tershakovec AM. Influence of metabolic syndrome factors and insulin resistance on the efficacy of ezetimibe/simvastatin and atorvastatin in patients with metabolic syndrome and atherosclerotic coronary heart disease risk. Lipids Health Dis. 2015 Sep 4;14:103. doi: 10.1186/s12944-015-0075-5. PubMed 26336957 ↗
  • Robinson JG, Ballantyne CM, Hsueh W, Rosen J, Lin J, Shah A, Lowe RS, Hanson ME, Tershakovec AM. Achievement of specified low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol apolipoprotein B, and high-sensitivity C-reactive protein levels with ezetimibe/simvastatin or atorvastatin in metabolic syndrome patients with and without atherosclerotic vascular disease (from the VYMET study). J Clin Lipidol. 2011 Nov-Dec;5(6):474-82. doi: 10.1016/j.jacl.2011.06.004. Epub 2011 Jun 15. PubMed 22108151 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
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
NCT00409773
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Dec 11, 2006
Start date
Jan 2007
Primary completion
Jul 2008
Completion
Jul 2008
Results posted
Aug 4, 2009
Last update
May 16, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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