Status:
COMPLETED
Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)
Lead Sponsor:
Organon and Co
Conditions:
Primary Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the overall safety, tolerability, and efficacy of Ezetimibe when used alone or in combination with a statin in patients with hypercholesterolemia
Eligibility Criteria
Inclusion
- Outpatient men or women, age 18 years and above.
- Patients with primary (heterozygous familial and non-familial) hypercholesterolemia or homozygous familial hypercholesterolemia.
Exclusion
- Known hypersensitivity to Ezetimibe.
- Moderate to severe hepatic insufficiency.
- Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal.
- Pregnancy or lactation.
- Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine
Key Trial Info
Start Date :
March 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
4105 Patients enrolled
Trial Details
Trial ID
NCT00704535
Start Date
March 1 2006
End Date
April 1 2008
Last Update
February 9 2022
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