Sitosterolemia Extension Study (0653-004)(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:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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|
- Plasma sitosterol levels after 52 weeks.
- Plasma LDL-C and plasma campesterol. Safety and tolerability.
|Study Start Date:||November 2001|
|Primary Completion Date:||November 2004 (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: NCT00092820
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|