Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Hypercholesterolemia; Homozygous Familial Hypercholesterolemia
Intervention: Ezetimibe (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Schering-Plough Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
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
Clinical Details
Official title: Post-Marketing Surveillance of the Safety, Tolerability and Efficacy of Ezetimibe Among Filipino Patients
Study design: Cohort, Prospective
Primary outcome: To evaluate the overall safety and tolerability of Ezetimibe
Secondary outcome: To evaluate the efficacy of Ezetimibe in lowering serum cholesterol levels
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Philippine Investigational Sites, Multiple Locations, Philippines; Recruiting
Additional Information
Starting date: March 2006
Ending date: January 2009
Last updated: July 24, 2008
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