Sitosterolemia Extension Study (0653-003)(COMPLETED)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
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
Actual Study Start Date
February 12, 2001
Actual Primary Completion Date
September 18, 2001
Actual Study Completion Date
November 30, 2004
Resource links provided by the National Library of Medicine
To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 10 mg/day.
Secondary Outcome Measures
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
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Ages Eligible for Study:
10 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with elevated sitosterol levels while taking current medication
Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.