Effectiveness of Two Approved Drugs in Lowering High Cholesterol (0733-224)
The purpose of this study is to evaluate the safety and effectiveness of two approved drugs in lowering high cholesterol when taken together, compared to taking only one of the drugs.
Drug: MK0733, simvastatin
Drug: Comparator: simvastatin
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Tolerability and Efficacy of the Co-Administration of Simvastatin 20 mg/Day and Fenofibrate 160 mg/Day Compared to Simvastatin 20 mg/Day Alone for 12 Weeks of Treatment in Patients With Combined Hyperlipidemia-Simvastatin and Fenofibrate Efficacy Trial (SAFARI)|
- Fasting triglyceride levels at 12 weeks.
- Total Cholesterol, LDL-C, HDL-C, VLDL-C, VLDL-TG, Apo A-I, and Apo B, CRP, PAI-1, fibrinogen, fasting plasma glucose, and fasting insulin
|Study Start Date:||May 2002|
|Study Completion Date:||March 2003|
|Primary Completion Date:||March 2003 (Final data collection date for primary outcome measure)|
The duration of treatment is 12 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092157
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|