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

Phase 3

Completed

• Conditions: Lipid Metabolism, Inborn Errors; Heart Disease

• Registration Number: NCT00092898
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

The duration of treatment is 26 weeks.

Study Timeline

• Study First Submitted: 2004-09-23
• Study First Submitted QC: 2004-09-27
• Study First Posted: 2004-09-28
• Study Start: 2004-10
• Primary Completion: 2005-09
• Study Completion: 2005-10
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sitosterol concentrations after 26 weeks.	After 26 weeks

Secondary Outcome Measures

Name	Time	Method
Campesterol concentrations; Achilles tendon thickness; safety and tolerability.