NCT00092898

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lipid Metabolism, Inborn Errors
• Heart Disease

Interventions

Type	Name	Description
DRUG	MK0653, ezetimibe
DRUG	Comparator: placebo

Timeline

• Start date: 2004-10-01
• Primary completion: 2005-09-01
• Completion: 2005-10-01
• First posted: 2004-09-28
• Last updated: 2024-08-15