Clinical Trial: An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Sitosterolem
Brief 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 Summary: The duration of treatment is 26 weeks.
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome: Sitosterol concentrations after 26 weeks. [ Time Frame: After 26 weeks ]
Original Primary Outcome:
Current Secondary Outcome: Campesterol concentrations; Achilles tendon thickness; safety and tolerability.
Original Secondary Outcome:
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: September 23, 2004
Date Started: October 2004
Date Completion:
Last Updated: March 7, 2017
Last Verified: March 2017