Sitosterolemia Extension Study (0653-003)(COMPLETED)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 23, 2004
Last updated: February 16, 2015
Last verified: February 2015

September 23, 2004
February 16, 2015
February 2001
September 2001   (final data collection date for primary outcome measure)
To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK-0653 10 mg/day.
Not Provided
Complete list of historical versions of study NCT00092807 on Archive Site
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
Not Provided
Not Provided
Not Provided
Sitosterolemia Extension Study (0653-003)(COMPLETED)
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

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.

The duration of treatment is 52 weeks.

Phase 3
Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • Lipid Metabolism, Inborn Errors
  • Heart Disease
  • Drug: MK0653, ezetimibe
  • Drug: Comparator: placebo
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2004
September 2001   (final data collection date for primary outcome measure)

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.
10 Years and older
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
P02257, 2004_032
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP