Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ezetimibe

Criteria

Inclusion Criteria:

• Outpatient men or women, age 18 years and above.

• Patients with primary (heterozygous familial and non-familial) hypercholesterolemia or homozygous familial hypercholesterolemia.

Exclusion Criteria:

• 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