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NCT00092833 Clinical Trial

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

Hypercholesterolemia, Familial Clinical Trial

Official title:
An Open-Label, Worldwide, Treatment Use Study to Provide Ezetimibe 10 Mg/Day to Patients With Homozygous Familial Hypercholesterolemia or Homozygous Sitosterolemia

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00092833
Other study ID # 0653-026
Secondary ID 2004_034
Status Terminated
Phase Phase 3
First received
Last updated
Start date July 2002
Est. completion date May 2005

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 49
Est. completion date May 2005
Est. primary completion date May 2005
Accepts healthy volunteers No
Gender All
Age group 8 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Comparator: ezetimibe
Ezetimibe (MK0653) 10 mg once daily for 3 years.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of clinical and laboratory adverse experiences in in patients with homozygous FH or homozygous sitosterolemia taking ezetimibe 10 mg/day 3 years
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