Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With Heterozygous Familial Hypercholesterolemia (Study P02579AM)(COMPLETED)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: ezetimibe (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Schering-Plough
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.
Clinical Details
Official title: Efficacy, Safety, and Tolerability of Ezetimibe in Coadministration With Simvastatin in the Therapy of Adolescents With Heterozygous Familial Hypercholesterolemia
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 10 Years.
Maximum age: 17 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: August 2005
Ending date: June 2007
Last updated: October 26, 2007
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