Sitosterolemia Extension Study (0653-003)(COMPLETED)
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.
Lipid Metabolism, Inborn Errors
Drug: MK0653, ezetimibe
Drug: Comparator: placebo
|Study Design:||Endpoint Classification: Safety Study
Primary Purpose: Treatment
|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 - 1 Year Open-Label Extension|
- To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 10 mg/day.
- Assess the percent change relative to baseline in LDL-C/plasma campesterol concentrations, and safety and tolerability after long-term treatment with MK0653 10 mg/day in patients with homozygous sitosterolemia
|Study Start Date:||February 2001|
|Study Completion Date:||November 2004|
|Primary Completion Date:||September 2001 (Final data collection date for primary outcome measure)|
The duration of treatment is 52 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092807
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|