Sitosterolemia Extension Study (0653-003)(COMPLETED)

Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092807
• Other study ID #: P02257
• Secondary ID: 2004_032
• Status: Completed
• Phase: Phase 3
• Start date: February 12, 2001
• Est. completion date: November 30, 2004

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The duration of treatment is 52 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 30, 2004
• Est. primary completion date: September 18, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases
• Lipid Metabolism, Inborn Errors
• Metabolism, Inborn Errors

Intervention

Drug:
• MK0653, ezetimibe

• Comparator: placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 10 mg/day.
Secondary	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