Sitosterolemia Extension Study (0653-004)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092820
First received: September 23, 2004
Last updated: May 24, 2013
Last verified: May 2013
  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:


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: 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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
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 Sharp & Dohme Corp.:
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 April 17, 2014