Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (Study P05522)



Status:Archived
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:May 2009
End Date:April 2012

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A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Efficacy and Safety Study of Ezetimibe Monotherapy in Children (Ages 6 to 10 Years) With Primary Hypercholesterolemia (Heterozygous Familial and Nonfamilial) (Phase 3, Protocol No. P05522)


The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to
placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12
weeks of treatment in children >=6 to <=10 years old with primary hypercholesterolemia. The
study will also evaluate the effect of ezetimibe on total cholesterol (TC), apolipoprotein B
(Apo B), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglycerides (TG).
The safety of ezetimibe in this subject population will also be evaluated.



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