Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Phase 3 Completed 355 enrolled Kowa Research Europe

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease.

Timeline

Start: 2005-09
Primary completion: 2006-10
Completion: 2006-10

Outcome

Met primary endpoint

paper The adjusted mean treatment difference (simvastatin--pitavastatin) was 0.31% (95% confidence interval -2.47, 3.09; P = 0.829), which was within the predefined noninferiority range. PMID 21874538 ↗

Publications

Eriksson M, Budinski D, Hounslow N. Comparative efficacy of pitavastatin and simvastatin in high-risk patients: a randomized controlled trial. Adv Ther. 2011 Sep;28(9):811-23. doi: 10.1007/s12325-011-0056-7. Epub 2011 Aug 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pitavastatin	Small molecule	4 mg	—
Comparator	Simvastatin	Small molecule	40 mg	—