Sitosterolemia Extension Study (0653-003)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00092807

First received: September 23, 2004

Last updated: February 16, 2015

Last verified: February 2015

History of Changes

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 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK0653 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 sitosterolemia

Genetic and Rare Diseases Information Center resources: Sitosterolemia Sphingolipidosis

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 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 MK0653 10 mg/day in patients with homozygous sitosterolemia


Enrollment:	37
Study Start Date:	February 2001
Study Completion Date:	November 2004
Primary Completion Date:	September 2001 (Final data collection date for primary outcome measure)

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092807

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Publications:

Salen G, von Bergmann K, Lütjohann 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 9.


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00092807 History of Changes
Other Study ID Numbers:	P02257, 2004_032
Study First Received:	September 23, 2004
Last Updated:	February 16, 2015
Health Authority:	Unspecified

Keywords provided by Merck Sharp & Dohme Corp.:


Homozygous Sitosterolemia

Additional relevant MeSH terms:


Heart Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Cardiovascular Diseases	Genetic Diseases, Inborn Lipid Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on February 26, 2015

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