Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)

Phase 3 Completed 400 enrolled Organon and Co

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to examine the long-term safety and tolerability of ezetimibe (SCH 58235) 10 mg once daily or placebo in combination with atorvastatin (10 to 80 mg/day) for up to 12 consecutive months in participants with primary hypercholesterolemia.

Timeline

Start: 2001-02-02
Primary completion: 2002-08-08
Completion: 2002-08-08

Publications

Results Ballantyne CM, Lipka LJ, Sager PT, Strony J, Alizadeh J, Suresh R, Veltri EP. Long-term safety and tolerability profile of ezetimibe and atorvastatin coadministration therapy in patients with primary hypercholesterolaemia. Int J Clin Pract. 2004 Jul;58(7):653-8. doi: 10.1111/j.1368-5031.2004.00278.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ezetimibe	Unknown	10 mg	—
Background	Atorvastatin	Small molecule	10 mg	—
Background	Atorvastatin	Small molecule	20 mg	—
Background	Atorvastatin	Small molecule	40 mg	—
Background	Atorvastatin	Small molecule	80 mg	—

Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)

Summary

Timeline

Publications

Drugs

Indications