Sitosterolemia Extension Study (0653-004)(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

NCT00092820

P02243

2004_033

Details and patient eligibility

About

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.

Full description

The duration of treatment is 52 weeks.

Enrollment: 58 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind