Efficacy and Safety of TAK-442 in Subjects Undergoing Total Knee Replacement

Phase 2 Completed 1045 enrolled Takeda

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to determine if TAK-442, once daily (QD) or twice daily (BID), is as safe and effective as enoxaparin in preventing the development of blood clots after knee replacement surgery.

Timeline

Start: 2007-10
Primary completion: 2008-10
Completion: 2008-10

Publications

Results Weitz JI, Cao C, Eriksson BI, Fisher W, Kupfer S, Raskob G, Spaeder J, Turpie AG. A dose-finding study with TAK-442, an oral factor Xa inhibitor, in patients undergoing elective total knee replacement surgery. Thromb Haemost. 2010 Dec;104(6):1150-7. doi: 10.1160/TH10-05-0273. Epub 2010 Sep 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Enoxaparin sodium	Other / unclassified	30 mg	Subcutaneous
Subject	LETAXABAN	Small molecule	10 mg	Oral
Subject	LETAXABAN	Small molecule	20 mg	Oral
Subject	LETAXABAN	Small molecule	40 mg	Oral
Subject	LETAXABAN	Small molecule	80 mg	Oral

Efficacy and Safety of TAK-442 in Subjects Undergoing Total Knee Replacement

Summary

Timeline

Publications

Drugs

Indications