Conditions: Primary Hypercholesterolemia
Keywords: heterozygous familial hypercholesterolemia nonfamilial hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 138
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Ezetimibe 10-mg tablet once daily for 12 weeks arm 2: Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks

Interventions: intervention 1: ezetimibe intervention 2: Placebo
Intervention descriptions: intervention 1: oral tablets: ezetimibe 10 mg once daily for 12 weeks intervention 2: oral tablets: placebo to match ezetimibe 10 mg; administered once daily during the 5-week, single-blind, placebo run-in and diet stabilization period and 12-week double-blind treatment period

Protocol document: