Sitosterolemia Extension Study (0653-004)(COMPLETED)

Phase 3

Completed

• Conditions: Heart Disease; Lipid Metabolism, Inborn Errors

• Registration Number: NCT00092820
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

The duration of treatment is 52 weeks.

Study Timeline

• Study Start: 2001-02-12
• Primary Completion: 2001-09-18
• Study First Submitted: 2004-09-23
• Study First Submitted QC: 2004-09-27
• Study First Posted: 2004-09-28
• Study Completion: 2004-11-30
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Plasma sitosterol levels after 52 weeks.

Secondary Outcome Measures

Name	Time	Method
Plasma LDL-C and plasma campesterol. Safety and tolerability.