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

Organon

Status: Completed

Conditions: Primary Hypercholesterolemia; Homozygous Familial Hypercholesterolemia

Treatments: Drug: Ezetimibe

Study type: Observational

Funder types: Industry

Identifiers

NCT00704535

P04748

Details and patient eligibility

About

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

Enrollment: 4,105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,105 participants in 1 patient group

Subjects with hypercholesterolemia

Description:

Subjects with hypercholesterolemia that are using Ezetimibe either alone or in combination with a statin

Treatment:

Drug: Ezetimibe