Sitosterolemia Extension Study (0653-004)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00092820

First received: September 23, 2004

Last updated: May 24, 2013

Last verified: May 2013

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:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) 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

Resource links provided by NLM:

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

MedlinePlus related topics: Heart Diseases

Drug Information available for: Ezetimibe

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Plasma sitosterol levels after 52 weeks.

Secondary Outcome Measures:

Plasma LDL-C and plasma campesterol. Safety and tolerability.

Enrollment:	25
Study Start Date:	November 2001
Primary Completion Date:	November 2004 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092820

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

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.

Lütjohann D, von Bergmann K, Sirah W, Macdonell G, Johnson-Levonas AO, Shah A, Lin J, Sapre A, Musliner T. Long-term efficacy and safety of ezetimibe 10 mg in patients with homozygous sitosterolemia: a 2-year, open-label extension study. Int J Clin Pract. 2008 Oct;62(10):1499-510.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00092820 History of Changes
Other Study ID Numbers:	2004_033, MK0653-004
Study First Received:	September 23, 2004
Last Updated:	May 24, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Homozygous Sitosterolemia

Additional relevant MeSH terms:

Heart Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Hypercholesterolemia
Intestinal Diseases
Cardiovascular Diseases
Genetic Diseases, Inborn
Lipid Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias

Gastrointestinal Diseases
Digestive System Diseases
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013

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