Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia - Tabular View

Tracking Information
First Received Date ^ICMJE	September 23, 2004
Last Updated Date	June 2, 2006
Start Date ^ICMJE	July 2002
Current Primary Outcome Measures ^ICMJE (submitted: January 13, 2006)	Plasma lipid levels.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00092833 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia
Official Title ^ICMJE	An Open-Label, Worldwide, Treatment Use Study to Provide Ezetimibe 10 Mg/Day to Patients With Homozygous Familial Hypercholesterolemia or Homozygous Sitosterolemia
Brief 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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	Hypercholesterolemia, Familial Lipid Metabolism, Inborn Errors
Intervention ^ICMJE	Drug: MK0653, ezetimibe / Duration of Treatment: 3 years
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	1600
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	8 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States
Expanded Access Status

Administrative Information
NCT ID ^ICMJE	NCT00092833
Responsible Party
Study ID Numbers ^ICMJE	2004_034
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Merck
Verification Date	September 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP