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

This study has been completed.

First Received: August 9, 2005 Last Updated: October 26, 2007 History of Changes

Sponsors and Collaborators:	Schering-Plough Merck
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00129402

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: ezetimibe	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy, Safety, and Tolerability of Ezetimibe in Coadministration With Simvastatin in the Therapy of Adolescents With Heterozygous Familial Hypercholesterolemia

Resource links provided by NLM:

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia primary carnitine deficiency

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Estimated Enrollment:	180
Study Start Date:	August 2005
Study Completion Date:	June 2007

Eligibility

Ages Eligible for Study:	10 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	P02579, EUDRACT NUMBER:2004-002627-40;, SCH 58235;, DOC ID 2526810
Study First Received:	August 9, 2005
Last Updated:	October 26, 2007
ClinicalTrials.gov Identifier:	NCT00129402 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

cholesterol
drugs
hypercholesterolemia
adolescent
randomized controlled trials

Study placed in the following topic categories:

Antimetabolites
Lipid Metabolism, Inborn Errors
Hyperlipidemias
Metabolic Diseases
Simvastatin
Antilipemic Agents
Hyperlipoproteinemia Type II
Ezetimibe
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hypercholesterolemia, Autosomal Dominant
Hypercholesterolemia
Metabolic Disorder
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Lipid Metabolism, Inborn Errors
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Hyperlipoproteinemia Type II
Enzyme Inhibitors
Ezetimibe

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on July 02, 2009