Sitosterolemia Extension Study (0653-004)(COMPLETED)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00092820

First Posted: September 28, 2004

Last Update Posted: May 11, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

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 Intervention Model: Parallel Assignment Masking: Double (Participant, 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 sitosterolemia

Drug Information available for: Ezetimibe

Genetic and Rare Diseases Information Center resources: Sitosterolemia

U.S. FDA Resources

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

Primary Outcome Measures:

Plasma sitosterol levels after 52 weeks.

Secondary Outcome Measures:

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


Enrollment:	58
Actual Study Start Date:	February 12, 2001
Study Completion Date:	November 30, 2004
Primary Completion Date:	September 18, 2001 (Final data collection date for primary outcome measure)

Detailed Description:

The duration of treatment is 52 weeks.

Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	10 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092820

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.

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. doi: 10.1111/j.1742-1241.2008.01841.x.

Study Data/Documents: CSR Synopsis This link exits the ClinicalTrials.gov site


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00092820 History of Changes
Other Study ID Numbers:	P02243 2004_033
First Submitted:	September 23, 2004
First Posted:	September 28, 2004
Last Update Posted:	May 11, 2017
Last Verified:	May 2017

Keywords provided by Merck Sharp & Dohme Corp.:


Homozygous Sitosterolemia

Additional relevant MeSH terms:


Heart Diseases Metabolism, Inborn Errors Lipid Metabolism, Inborn Errors Cardiovascular Diseases Genetic Diseases, Inborn Metabolic Diseases Lipid Metabolism Disorders	Ezetimibe Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents

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