A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus Low Molecular Weight (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis

PHASE2CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

January 31, 2014

Study Completion Date

March 31, 2014

Conditions
Deep Vein ThrombosisVenous Thrombosis
Interventions
DRUG

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

DRUG

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.

DRUG

warfarin

tablet for oral use; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; 90 days treatment.

Trial Locations (34)

Unknown

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY