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

Organon and Co30 enrolled

Overview

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.

The duration of treatment is 26 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Lipid Metabolism, Inborn Errors Heart Disease

Interventions

MK0653, ezetimibeDRUG

Comparator: placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Sitosterol concentrations after 26 weeks.

Time frame: After 26 weeks

Secondary Outcomes

Campesterol concentrations; Achilles tendon thickness; safety and tolerability.

Data from ClinicalTrials.gov

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