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

Cholesterol Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652301
• Other study ID #: 0653-050
• Secondary ID: MK0653-0502007_5
• Status: Completed
• Phase: Phase 3
• Start date: July 2003
• Est. completion date: April 2004

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholesterol

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Organon and Co	Schering-Plough

References & Publications (1)

Sudhop T, Reber M, Tribble D, Sapre A, Taggart W, Gibbons P, Musliner T, von Bergmann K, Lütjohann D. Changes in cholesterol absorption and cholesterol synthesis caused by ezetimibe and/or simvastatin in men. J Lipid Res. 2009 Oct;50(10):2117-23. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone.		Based on 7 week treatment periods.
Secondary	To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption.		Based on 7 week treatment periods.