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An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092898
First received: September 23, 2004
Last updated: January 21, 2010
Last verified: January 2010
History of Changes
  Purpose

This is a 6-month study with patients who have the rare disease, sitosterolemia which may result in heart-related diseases. These patients have unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study investigates whether absorption of these non-cholesterols can be reduced in these patients.


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 Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to An Ongoing Regimen of Ezetimibe 10 mg in Patients Homozygous Sitosterolemia

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:
  • Sitosterol concentrations after 26 weeks. [ Time Frame: After 26 weeks ]

Secondary Outcome Measures:
  • Campesterol concentrations; Achilles tendon thickness; safety and tolerability.

Enrollment: 30
Study Start Date: October 2004
Study Completion Date: March 2006
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed Description:

The duration of treatment is 26 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older, with a history of elevated sitosterol levels and have received treatment for at least 6 months prior to study entry.

Exclusion Criteria:

  • Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092898

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092898     History of Changes
Other Study ID Numbers: 2004_038, MK0653-062
Study First Received: September 23, 2004
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
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