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

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.

Inclusion Criteria:

• Each subject may be of either sex and of any race/ethnicity, and must be >=6 and <=10 years of age, with a diagnosis of primary hypercholesterolemia (heterozygous familial or nonfamilial) despite being on a lipid-lowering diet for at least 3 months with a LDL-C of >159mg/dL
• Each subject's parent/guardian must be willing to give written informed consent on his/her behalf.

Exclusion Criteria:

Each subject must not:

• Have known hypersensitivity or any contraindication to ezetimibe.
• Have use of any investigational drugs within 30 days of study entry.
• Be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.
• Be a female of child-bearing potential who is pregnant, intends to become pregnant, or is nursing
• Have known congenital cardiac disorder.
• Have documented or laboratory values consistent with homozygous familial hypercholesterolemia (HoFH).
• Be known to be human immunodeficiency virus (HIV) positive.