Sitosterolemia Extension Study - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092807

Purpose

This is an extension study for patients having unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study will evaluate the long term safety and the ability to lower cholesterol levels with an investigational drug.

Condition	Intervention	Phase
Lipid Metabolism, Inborn Errors Heart Disease	Drug: MK0653, ezetimibe Drug: Comparator: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK-0653 When Added to Current Regimen in Patients With Homozygous Sitosterolemia - 1 Year Open-Label Extension

Resource links provided by NLM:

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis primary carnitine deficiency

MedlinePlus related topics: Heart Diseases

Drug Information available for: Ezetimibe

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK-0653 10 mg/day.

Secondary Outcome Measures:

Assess the percent change relative to baseline in LDL-C/plasma campesterol concentrations, and safety and tolerability after long-term treatment with MK-0653 10 mg/day in patients with homozygous sitosterolemia

Estimated Enrollment:	14
Study Start Date:	March 2001

Detailed Description:

The duration of treatment is 52 weeks.

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with elevated sitosterol levels while taking current medication

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: NCT00092807

Locations

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

Sponsors and Collaborators

Merck

More Information

Publications:

Salen G, von Bergmann K, Lutjohann D, Kwiterovich P, Kane J, Patel SB, Musliner T, Stein P, Musser B; Multicenter Sitosterolemia Study Group. Ezetimibe effectively reduces plasma plant sterols in patients with sitosterolemia. Circulation. 2004 Mar 2;109(8):966-71. Epub 2004 Feb 09.

Study ID Numbers:	2004_032
Study First Received:	September 23, 2004
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00092807 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Homozygous Sitosterolemia

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Sitosterolemia
Metabolic Diseases
Heart Diseases

Genetic Diseases, Inborn
Ezetimibe
Metabolic Disorder
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Heart Diseases

Genetic Diseases, Inborn
Cardiovascular Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on August 13, 2009