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NCT00092820 Clinical Trial

Sitosterolemia Extension Study (0653-004)(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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00092820
Other study ID # P02243
Secondary ID 2004_033
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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 58
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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0653, ezetimibe

• Comparator: placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (2)

Lütjohann D, von Bergmann K, Sirah W, Macdonell G, Johnson-Levonas AO, Shah A, Lin J, Sapre A, Musliner T. Long-term efficacy and safety of ezetimibe 10 mg in patients with homozygous sitosterolemia: a 2-year, open-label extension study. Int J Clin Pract. 2008 Oct;62(10):1499-510. doi: 10.1111/j.1742-1241.2008.01841.x. — View Citation

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 Plasma sitosterol levels after 52 weeks.
Secondary Plasma LDL-C and plasma campesterol. Safety and tolerability.
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