A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED)
Phase 3
Completed
- Conditions
- Coronary Disease
- Registration Number
- NCT00551447
- Lead Sponsor
- Organon and Co
- Brief Summary
This purpose of this study is to determine if the administration of ezetimibe and simvastatin together is more effective than simvastatin alone in lowering LDL-C levels to a goal of \<100 mg/dL in patients at risk for Heart Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 616
Inclusion Criteria
- Men and women aged 18 to 80 at risk for Heart Disease who have LDL-C levels greater than or equal to 130 mg/dL and triglyceride level less than or equal to 350 mg/dL
- Patients must be able to maintain the National Cholesterol Education Program diet throughout the course of the study
Exclusion Criteria
- Patients are excluded from the study if their weight is less than 50% of ideal body weight, if they are pregnant or lactating, have congestive heart failure, uncontrolled heart rhythm problems or a recent heart attack, coronary artery bypass surgery, or angioplasty. Additionally, patients with poorly controlled Type 1 or 2 diabetes mellitus, kidney disease, uncontrolled endocrine or metabolic disease, are known HIV positive, and uncontrolled high blood pressure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method LDL-C measurement (target goal = <100 mg/dL) 27 Weeks
- Secondary Outcome Measures
Name Time Method Well tolerated in patients 27 Weeks