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

This study has been completed.

First Received: June 23, 2008 Last Updated: September 26, 2008 History of Changes

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00704535

Purpose

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

Condition	Intervention
Primary Hypercholesterolemia Homozygous Familial Hypercholesterolemia	Drug: Ezetimibe

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency

MedlinePlus related topics: Cholesterol

Drug Information available for: Ezetimibe

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Post-Marketing Surveillance of the Safety, Tolerability and Efficacy of Ezetimibe Among Filipino Patients

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

To evaluate the overall safety and tolerability of Ezetimibe [ Time Frame: 28 days after Visit 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the efficacy of Ezetimibe in lowering serum cholesterol levels [ Time Frame: 28 days after Visit 1 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	3000
Study Start Date:	March 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Subjects with hypercholesterolemia Subjects with hypercholesterolemia that are using Ezetimibe either alone or in combination with a statin	Drug: Ezetimibe 1 tablet of 10 mg once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Filipino subjects with hypercholesterolemia

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04748
Study First Received:	June 23, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00704535 History of Changes
Health Authority:	Philippines: Bureau of Food and Drugs

Study placed in the following topic categories:

Antimetabolites
Lipid Metabolism, Inborn Errors
Hyperlipidemias
Metabolic Diseases
Antilipemic Agents
Hyperlipoproteinemia Type II
Ezetimibe
Anticholesteremic Agents

Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hypercholesterolemia, Autosomal Dominant
Hypercholesterolemia
Metabolic Disorder
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Lipid Metabolism, Inborn Errors
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Hyperlipoproteinemia Type II
Ezetimibe
Anticholesteremic Agents

Pharmacologic Actions
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009