Sitosterolemia Extension Study (0653-003)(COMPLETED)

Organon and Co37 enrolled

Overview

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.

The duration of treatment is 52 weeks.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Lipid Metabolism, Inborn Errors Heart Disease

Interventions

MK0653, ezetimibeDRUG

Comparator: placeboDRUG

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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