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
Verified date | February 2022 |
Source | Organon and Co |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Organon and Co | Schering-Plough |
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
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. |
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