Clinical trial NCT00409773: Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)
Official title: A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients With Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Metabolic Syndrome
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-12-11
Enrollment: 1143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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)

Primary outcomes:
measure: Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6
timeFrame: Baseline and 6 Weeks
Secondary outcomes:
measure: Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6
timeFrame: Baseline and 6 Weeks
measure: Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6
timeFrame: Baseline and 6 Weeks
measure: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6
timeFrame: Baseline and 6 Weeks
measure: Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
timeFrame: Baseline and 6 Weeks
measure: Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6
timeFrame: Baseline and 6 Weeks
measure: Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6
timeFrame: Baseline and 6 Weeks
measure: Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6
timeFrame: Baseline and 6 Weeks
measure: Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6
timeFrame: Baseline and 6 Weeks
measure: Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6
timeFrame: Baseline and 6 Weeks
measure: Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6
timeFrame: Baseline and 6 weeks
measure: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6
timeFrame: Baseline and 6 Weeks
measure: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)
timeFrame: Baseline and 6 Weeks
measure: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)
timeFrame: Baseline and 6 Weeks
measure: Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6
timeFrame: Baseline and 6 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.