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

Organon

Status and phase: Terminated; Phase 3

Conditions: Hypercholesterolemia, Familial; Lipid Metabolism, Inborn Errors

Treatments: Drug: Comparator: ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092833

2004_034

0653-026

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

1

Experimental group

Description:

Ezetimibe

Treatment:

Drug: Comparator: ezetimibe