Text Size

Sitosterolemia Extension Study

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092807
First received: September 23, 2004
Last updated: May 17, 2006
Last verified: October 2005
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 MK-0653 When Added to Current Regimen in Patients With Homozygous Sitosterolemia - 1 Year Open-Label Extension

Resource links provided by NLM:

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:

ClinicalTrials.gov Identifier: NCT00092807     History of Changes
Other Study ID Numbers: 2004_032
Study First Received: September 23, 2004
Last Updated: May 17, 2006
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 May 16, 2013