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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:

Drug Information available for: Ezetimibe
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   (Child, Adult, Senior)
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:

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
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

ClinicalTrials.gov processed this record on September 23, 2016