Sitosterolemia Extension Study (0653-004)(COMPLETED)

Organon and Co58 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

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

Plasma sitosterol levels after 52 weeks.

Secondary Outcomes

Plasma LDL-C and plasma campesterol. Safety and tolerability.

Data from ClinicalTrials.gov

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