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Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia (0653-026)(COMPLETED)

Last Updated: 2024-08-15

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2005-05-31

Brief Summary

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The purpose of this study is to provide an investigational drug to patients with a specific type of hypercholesterolemia (high cholesterol) or sitosterolemia (unusually high absorption of non-cholesterol sterols) in a treatment use setting.

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Detailed Description

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Conditions

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Hypercholesterolemia, Familial Lipid Metabolism, Inborn Errors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Ezetimibe

Group Type EXPERIMENTAL

Comparator: ezetimibe

Intervention Type DRUG

Ezetimibe (MK0653) 10 mg once daily for 3 years.

Interventions

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Comparator: ezetimibe

Ezetimibe (MK0653) 10 mg once daily for 3 years.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Homozygous familial hypercholesterolemia or sitosterolemia

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

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers