Sitosterolemia Extension Study (0653-004)(COMPLETED)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-12

Study Completion Date

2004-11-30

Brief Summary

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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.

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Detailed Description

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The duration of treatment is 52 weeks.

Conditions

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Lipid Metabolism, Inborn Errors Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0653, ezetimibe

Intervention Type DRUG

Comparator: placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No