A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)
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
3 other identifiers
interventional
40
0 countries
N/A
Brief Summary
To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2003
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 31, 2008
CompletedFirst Posted
Study publicly available on registry
April 3, 2008
CompletedAugust 15, 2024
February 1, 2022
9 months
March 31, 2008
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone.
Based on 7 week treatment periods.
Secondary Outcomes (1)
To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption.
Based on 7 week treatment periods.
Study Arms (4)
1
EXPERIMENTALezetimibe 10 mg tablet plus simvastatin 20 mg tablet
2
ACTIVE COMPARATORezetimibe 10 mg tablet
3
ACTIVE COMPARATORsimvastatin 20 mg tablet
4
PLACEBO COMPARATORmatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- Healthy males between the ages of 18-55 with LDL More than 130, but less than 180
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
- Schering-Ploughcollaborator
Related Publications (1)
Sudhop T, Reber M, Tribble D, Sapre A, Taggart W, Gibbons P, Musliner T, von Bergmann K, Lutjohann 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: 10.1194/jlr.P900004-JLR200. Epub 2009 Apr 20.
PMID: 19380898RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2008
First Posted
April 3, 2008
Study Start
July 1, 2003
Primary Completion
April 1, 2004
Study Completion
April 1, 2004
Last Updated
August 15, 2024
Record last verified: 2022-02