A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation

Phase 2 Completed 222 enrolled Pfizer Bristol-Myers Squibb · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.

Timeline

Start: 2008-06
Primary completion: 2009-09
Completion: 2009-09

Publications

Ogawa S, Shinohara Y, Kanmuri K. Safety and efficacy of the oral direct factor xa inhibitor apixaban in Japanese patients with non-valvular atrial fibrillation. -The ARISTOTLE-J study-. Circ J. 2011;75(8):1852-9. doi: 10.1253/circj.cj-10-1183. Epub 2011 Jun 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apixaban	Small molecule	2.5 mg	Oral
Subject	Apixaban	Small molecule	5 mg	Oral
Comparator	Warfarin	Small molecule	—	Oral

A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation

Summary

Timeline

Publications

Drugs

Indications