85
Participants
Start Date
August 31, 2012
Primary Completion Date
January 31, 2014
Study Completion Date
March 31, 2014
edoxaban tosylate
edoxaban tosylate (DU-176b), film-coated for oral use, 90 mg once daily (QD) for 10 days (±2 days) followed by 60 mg QD for a total of approximately 90 days of edoxaban treatment
enoxaparin/unfractionated heparin
enoxaparin - administered by subcutaneous injection;1 mg/kg/ twice daily or 1.5 mg/kg once daily unfractionated heparin - started with 5000 IU bolus intravenous administration, 1300 IU/h continuous infusion, minimum of 5 days of treatment and stopped when target INR (2.0 - 3.0) is achieved.
warfarin
tablet for oral use; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; 90 days treatment.
Dothan
Montgomery
Sacramento
Atlantis
Clearwater
Fort Myers
Jacksonville
Sarasota
Tampa
Jonesboro
Lafayette
Paducah
Covington
Annapolis
Baltimore
Randallstown
Butte
Grand Island
Rochester
Durham
Greensboro
Wilmington
Maumee
Camp Hill
Ephrata
Sellersville
Rapid City
Fredericksburg
Tacoma
Edmonton
London
Newmarket
Greenfield Park
Montreal
Lead Sponsor
Daiichi Sankyo
INDUSTRY