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

Phase 3TerminatedNCT00092833

Organon and Co49 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypercholesterolemia, Familial Lipid Metabolism, Inborn Errors

Interventions

Comparator: ezetimibeDRUG

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

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of clinical and laboratory adverse experiences in in patients with homozygous FH or homozygous sitosterolemia taking ezetimibe 10 mg/day

Time frame: 3 years

Data from ClinicalTrials.gov

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