drugset / Trial / NCT03885921

Safety and Tolerability Study of Ezetimibe (SCH 058235/MK-0653) Plus Atorvastatin or Simvastatin in Homozygous Familial Hypercholesterolemia (P01417/MK-0653-019)

NCT03885921

Phase 3 Completed 44 enrolled Organon and Co
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary purpose of this study is to evaluate the long-term safety and tolerability of ezetimibe (SCH 058235/MK-0653) 10 mg dosed daily and co-administered with either atorvastatin or simvastatin for up to 24 months in participants with homozygous familial hypercholesterolemia (FH). Following completion of the 12-week, double-blind, efficacy and safety parent study (P01030/MK-0653-018; NCT03884452) participants will be offered entry into this open-label, 24-month extension study.

Timeline

Start
2000-10-25
Primary completion
2003-07-08
Completion
2003-07-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 40 mg Oral
Subject Ezetimibe Unknown 10 mg Oral
Subject Simvastatin Small molecule 40 mg Oral