Efficacy, Safety, and Tolerability of Ezetimibe and Simvastatin Taken Together, for the treatment of Adolescents With Heterozygous Familial Hypercholesterolemia

Efficacy, Safety, and Tolerability of Ezetimibe in Coadministration With Simvastatin in the Therapy of Adolescents With Heterozygous Familial Hypercholesterolemia

Registry ID

EUCTR2004-002627-40

Source registry

EUCTR

Phase

PHASE3

Sponsor

Schering-Plough Research Institute, a division of Schering Corporation

Last update

2026-08-16

Conditions

• Heterozygous Familial Hypercholesterolemia
• Adolescent (age >=10 and <=17 years) subjects with Heterozygous Familial Hypercholesterolemia (HeFH).
• Therapy of adolescents with etherozygous familial hypercholesterolemia

Summary

Study objective was to test the following hypothesis: Primary Hypothesis In adolescent subjects with heterozygous familial hypercholesterolemia (HeFH), coadministration of ezetimibe (EZ) 10 mg/day plus simvastatin (simva) 10 mg/day, 20 mg/day, or 40 mg/day will result in a greater lowdensity-lipoprotein cholesterol (LDL-C) reduction compared with simva 10 mg/day, 20 mg/day, or 40 mg/day as monotherapy measured as percent change from Baseline to Week 6 (end of Step 1) in the pooled groups.

Locations

• , , Austria
• , , Italy
• , , Germany
• , , Finland
• , , Spain

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