Clinical Trial: Sitosterolemia Extension Study (0653-003)(COMPLETED)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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-L
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 Summary: The duration of treatment is 52 weeks.
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome: To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 10 mg/day.
Original Primary Outcome:
Current Secondary Outcome: 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
Original Secondary Outcome:
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: September 23, 2004
Date Started: February 12, 2001
Date Completion:
Last Updated: May 10, 2017
Last Verified: May 2017