Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)
This study will evaluate patients who have coronary heart disease to determine if an investigational drug will further lower cholesterol when taken in combination with an approved cholesterol lowering medication.
Drug: MK0653, ezetimibe
Drug: Comparator: ezetimibe, placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Co-administered With Existing Simvastatin 10 mg or 20 mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease.|
- Percentage of patients reaching LDL goal of <2.60 mmol/L after 6 weeks of treatment
- Safety and tolerability.
|Study Start Date:||February 2003|
|Study Completion Date:||July 2004|
|Primary Completion Date:||June 2004 (Final data collection date for primary outcome measure)|
The duration of treatment is 10 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092599
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|