Clinical Trials Directory

Trials / Completed

CompletedNCT00092820

Sitosterolemia Extension Study (0653-004)(COMPLETED)

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
58 (actual)
Sponsor
Organon and Co · Industry
Sex
All
Age
10 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGMK0653, ezetimibe
DRUGComparator: placebo

Timeline

Start date
2001-02-12
Primary completion
2001-09-18
Completion
2004-11-30
First posted
2004-09-28
Last updated
2024-08-15

Source: ClinicalTrials.gov record NCT00092820. Inclusion in this directory is not an endorsement.