An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)

Organon

Status and phase: Completed; Phase 3

Conditions: Lipid Metabolism, Inborn Errors; Heart Disease

Treatments: Drug: Comparator: placebo; Drug: MK0653, ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092898

2004_038

0653-062

MK0653-062

Details and patient eligibility

About

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.

Full description

The duration of treatment is 26 weeks.

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older, with a history of elevated sitosterol levels and have received treatment for at least 6 months prior to study entry.

Exclusion criteria

• Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind