drugset / Trial / NCT00129402

Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)

NCT00129402

Phase 3 Completed 248 enrolled Organon and Co Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double-blind, controlled, parallel-group, multicenter, Phase-3 study to evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages 10-17 years with Heterozygous Familial Hypercholesterolemia.

Timeline

Start
2005-08
Primary completion
2007-06
Completion
2007-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg
Comparator Simvastatin Small molecule 10 mg
Comparator Simvastatin Small molecule 20 mg
Comparator Simvastatin Small molecule 40 mg