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A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
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 Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

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

Merck: Patient & Caregiver U.S. Product Web Site

Starting date: July 2003
Last updated: February 16, 2015

Page last updated: August 23, 2015

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