An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)
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.
Lipid Metabolism, Inborn Errors
Drug: MK0653, ezetimibe
Drug: Comparator: placebo
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Sitosterol concentrations after 26 weeks. [ Time Frame: After 26 weeks ]
- Campesterol concentrations; Achilles tendon thickness; safety and tolerability.
|Study Start Date:||October 2004|
|Study Completion Date:||March 2006|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
The duration of treatment is 26 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092898
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|