Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)
Phase 3
Completed
- Conditions
- HypercholesterolemiaMetabolic Syndrome
- Interventions
- Registration Number
- NCT00409773
- Lead Sponsor
- Organon and Co
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1143
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 ezetimibe (+) simvastatin Arm 3: drug + comparator + Placebo 1 ezetimibe (+) simvastatin Arm 1: drug + comparator + Placebo 2 ezetimibe (+) simvastatin Arm 2: drug + comparator + Placebo 4 ezetimibe (+) simvastatin Arm 4: drug + comparator + Placebo 5 ezetimibe (+) simvastatin Arm 5: drug + comparator + Placebo
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 Baseline and 6 Weeks
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6 Baseline and 6 Weeks Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6 Baseline and 6 Weeks Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 Baseline and 6 Weeks Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 Baseline and 6 Weeks Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6 Baseline and 6 Weeks Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6 Baseline and 6 Weeks Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6 Baseline and 6 Weeks Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6 Baseline and 6 Weeks Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6 Baseline and 6 Weeks Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6 Baseline and 6 weeks Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6 Baseline and 6 Weeks Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD) Baseline and 6 Weeks Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD) Baseline and 6 Weeks Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6 Baseline and 6 Weeks