NCT00867165

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ezetimibe	oral tablets: ezetimibe 10 mg once daily for 12 weeks
DRUG	Placebo	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

Timeline

• Start date: 2009-05-21
• Primary completion: 2012-04-13
• Completion: 2012-04-13
• First posted: 2009-03-23
• Last updated: 2024-05-21
• Results posted: 2013-05-30