An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)

Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092898
• Other study ID #: 0653-062
• Secondary ID: MK0653-0622004_0
• Status: Completed
• Phase: Phase 3
• Start date: October 2004
• Est. completion date: October 2005

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 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.

Description:

The duration of treatment is 26 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

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)

Musliner T, Cselovszky D, Sirah W, McCrary Sisk C, Sapre A, Salen G, Lütjohann D, von Bergmann K. Efficacy and safety of ezetimibe 40 mg vs. ezetimibe 10 mg in the treatment of patients with homozygous sitosterolaemia. Int J Clin Pract. 2008 Jul;62(7):995-1000. doi: 10.1111/j.1742-1241.2008.01786.x. Epub 2008 May 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sitosterol concentrations after 26 weeks.		After 26 weeks
Secondary	Campesterol concentrations; Achilles tendon thickness; safety and tolerability.