Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00092807
NCT00092807CompletedPhase 3

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

Organon and Co0 sites37 target enrollmentStarted: February 12, 2001Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
37
Primary Endpoint
To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 10 mg/day.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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 Description

The duration of treatment is 52 weeks.

Study Design

Study Type
Interventional
Primary Purpose
Treatment

Eligibility Criteria

Ages
10 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with elevated sitosterol levels while taking current medication

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 10 mg/day.

Secondary Outcomes

  • 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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Similar Trials

Completed
Phase 3
Sitosterolemia Extension Study (0653-004)(COMPLETED)Heart DiseaseLipid Metabolism, Inborn Errors
NCT00092820Organon and Co58
Completed
Phase 3
An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)Lipid Metabolism, Inborn ErrorsHeart Disease
NCT00092898Organon and Co30
Completed
Phase 3
Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or DyslipidemiaHyperlipidemia
NCT02458287Pfizer299
Completed
Phase 4
Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver DiseaseHypercholesterolemia
NCT00529178Bristol-Myers Squibb232
Completed
Phase 3
SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical ResearchPrimary Hypercholesterolemia
NCT04844125Jiangsu HengRui Medicine Co., Ltd.144