Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)

Phase 3 Completed 50 enrolled Organon and Co

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to evaluate the efficacy and the safety of ezetimibe (SCH 58235) co-administered with either atorvastatin or simvastatin in participants with homozygous familial hypercholesterolemia (FH).

Timeline

Start: 2000-05-03
Primary completion: 2001-05-24
Completion: 2001-05-24

Outcome

Met primary endpoint

paper Ezetimibe plus statin-40/80 significantly reduced LDL-C levels compared with statin-80 (-20.7% versus -6.7%, P=0.007). PMID 12034651 ↗

Publications

Results Gagne C, Gaudet D, Bruckert E; Ezetimibe Study Group. Efficacy and safety of ezetimibe coadministered with atorvastatin or simvastatin in patients with homozygous familial hypercholesterolemia. Circulation. 2002 May 28;105(21):2469-75. doi: 10.1161/01.cir.0000018744.58460.62.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atorvastatin	Small molecule	40 mg	Oral
Subject	Atorvastatin	Small molecule	80 mg	Oral
Subject	Ezetimibe	Unknown	10 mg	Oral
Subject	Simvastatin	Small molecule	40 mg	Oral
Subject	Simvastatin	Small molecule	80 mg	Oral