Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia

This study is ongoing, but not recruiting participants.

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092833

Purpose

The purpose of this study is to provide an investigational drug to patients with a specific type of hypercholesterolemia (high cholesterol) or sitosterolemia (unusually high absorption of non-cholesterol sterols) in a treatment use setting.

Condition	Intervention	Phase
Hypercholesterolemia, Familial Lipid Metabolism, Inborn Errors	Drug: MK0653, ezetimibe / Duration of Treatment: 3 years	Phase III

Genetics Home Reference related topics: 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:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	An Open-Label, Worldwide, Treatment Use Study to Provide Ezetimibe 10 Mg/Day to Patients With Homozygous Familial Hypercholesterolemia or Homozygous Sitosterolemia

Further study details as provided by Merck:

Primary Outcome Measures:

Plasma lipid levels.

Estimated Enrollment:	1600
Study Start Date:	July 2002

Eligibility

Ages Eligible for Study:	8 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Homozygous familial hypercholesterolemia or sitosterolemia

Exclusion Criteria:

Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092833

Locations

United States, Pennsylvania
Call for Information
Horsham, Pennsylvania, United States, 19044

Sponsors and Collaborators

Merck

More Information

Study ID Numbers:	2004_034
Study First Received:	September 23, 2004
Last Updated:	June 2, 2006
ClinicalTrials.gov Identifier:	NCT00092833
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Homozygous, Familial; Sitosterolemia

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors
Hypercholesterolemia, autosomal dominant
Hyperlipidemias
Metabolic Diseases
Hyperlipoproteinemia Type II
Ezetimibe
Metabolism, Inborn Errors

Sitosterolemia
Genetic Diseases, Inborn
Metabolic disorder
Hypercholesterolemia
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antilipemic Agents
Anticholesteremic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009