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 |
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.
We found this trial at
10
sites
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