A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cholesterol
Intervention: ezetimibe (Drug); Comparator: Placebo (unspecified) (Drug); simvastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and
simvastatin given alone on intestinal cholesterol absorption.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled,4-Period, Crossover Study to Evaluate the Effects of Ezetimibe and Simvastatin, Coadministered and Alone, on Intestinal Absorption of Cholesterol
Study design: Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone.
Secondary outcome: To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption.
Detailed description:
Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week
treatment periods.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Additional Information
MedWatch - FDA maintained medical product safety Information PhRMA Clinical Study Results Database - web-based repository for clinical study results Merck: Patient & Caregiver U.S. Product Web Site
Starting date: July 2003
Last updated: March 31, 2008
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