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”

To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.

Study Type: Interventional

Study Design: Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: April 2004

Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week treatment periods.

Intervention(s) in this Clinical Trial

• Drug: ezetimibe
  • ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.
• Drug: Comparator: Placebo (unspecified)
  • matching placebo tablet. Duration of Treatment 31 Weeks.
• Drug: simvastatin
  • simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • ezetimibe 10 mg tablet plus simvastatin 20 mg tablet
• Active Comparator: 2
  • ezetimibe 10 mg tablet
• Active Comparator: 3
  • simvastatin 20 mg tablet
• Placebo Comparator: 4
  • matching placebo

Primary Measures

• reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone.
  • Time Frame: Based on 7 week treatment periods.
    Safety Issue?: No

Secondary Measures

• To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption.
  • Time Frame: Based on 7 week treatment periods.
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00652301

Study ID Number: 2007_559

ClinicalTrials.gov Identifier: NCT00652301

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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