Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With Heterozygous Familial Hypercholesterolemia (Study P02579AM)(COMPLETED) - Tabular View

Tracking Information
First Received Date ^ICMJE	August 9, 2005
Last Updated Date	October 26, 2007
Start Date ^ICMJE	August 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00129402 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With Heterozygous Familial Hypercholesterolemia (Study P02579AM)(COMPLETED)
Official Title ^ICMJE	Efficacy, Safety, and Tolerability of Ezetimibe in Coadministration With Simvastatin in the Therapy of Adolescents With Heterozygous Familial Hypercholesterolemia
Brief Summary	This is a randomized, double-blind, controlled, parallel-group, multicenter, Phase-3 study to evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages 10 -17 years with Heterozygous Familial Hypercholesterolemia.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Hypercholesterolemia
Intervention ^ICMJE	Drug: ezetimibe
Study Arms / Comparison Groups
Publications *	van der Graaf A, Cuffie-Jackson C, Vissers MN, Trip MD, Gagné C, Shi G, Veltri E, Avis HJ, Kastelein JJ. Efficacy and safety of coadministration of ezetimibe and simvastatin in adolescents with heterozygous familial hypercholesterolemia. J Am Coll Cardiol. 2008 Oct 21;52(17):1421-9.
* 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	Completed
Enrollment ^ICMJE	180
Completion Date	June 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Adolescent (ages 10 - 17 years) boys or girls weighing at least 88 lbs (40 kg). Subjects must have high cholesterol (low density lipoprotein cholesterol [LDL-C] more than 159 mg/dL or 4.1 mmol/L) and a family history of high cholesterol. Exclusion Criteria: Subjects diagnosed with delayed puberty. Subjects who are sensitive to simvastatin and/or ezetimibe. Subjects who drink alcohol excessively or who have a history of alcohol or drug abuse within the past 2 years. Subjects who are known to be HIV positive, are undergoing LDL apheresis or plasma apheresis, or have had a partial ileal bypass.
Gender	Both
Ages	10 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00129402
Responsible Party
Study ID Numbers ^ICMJE	P02579, EUDRACT NUMBER:2004-002627-40;, SCH 58235;, DOC ID 2526810
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Merck
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	October 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP