A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)
- Registration Number
- NCT00652301
- Lead Sponsor
- Organon and Co
- Brief Summary
To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.
- Detailed Description
Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week treatment periods.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
Inclusion Criteria
- Healthy males between the ages of 18-55 with LDL More than 130, but less than 180
Exclusion Criteria
- Individuals with drug or substance abuse
- Individuals with poor mental function
- Individuals having more than 14 alcoholic drinks a week
- Individuals that have been treated with any other investigational drug in the last 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 ezetimibe ezetimibe 10 mg tablet plus simvastatin 20 mg tablet 1 simvastatin ezetimibe 10 mg tablet plus simvastatin 20 mg tablet 2 ezetimibe ezetimibe 10 mg tablet 3 simvastatin simvastatin 20 mg tablet
- Primary Outcome Measures
Name Time Method reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone. Based on 7 week treatment periods.
- Secondary Outcome Measures
Name Time Method To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption. Based on 7 week treatment periods.