Cancer Venous Thromboembolism (VTE)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,046

Participants

Timeline

Start Date

July 16, 2015

Primary Completion Date

September 15, 2017

Study Completion Date

September 15, 2017

Conditions
Venous Thromboembolism (VTE)Deep Vein Thrombosis (DVT)Pulmonary Embolism (PE)Cancer
Interventions
DRUG

Edoxaban

After the 5 day treatment with LMWH, patients receive edoxaban 60 mg once daily (QD) as 2 × 30 mg tablets (or 1 x 30 mg tablet QD for patients requiring dose adjustment) for the remainder of the treatment period.

DRUG

Dalteparin

Dalteparin was administered via subcutaneous injection at a dose of 200 IU/kg (maximum daily dose 18,000 IU) for 30 days, and at a dose of 150 IU/kg from Day 31 to the end of treatment.

DRUG

Low molecular weight heparin

Therapeutic doses of subcutaneous LMWH were administered for at least 5 days (to patients in the edoxaban group); this 5-day period may have included the pre-randomization LMWH (if applicable). The choice of parenteral LMWH was up to the treating physician.

Trial Locations (9)

Unknown

Brandon

Jonesboro

Detroit

Norfolk

Leuven

Saint-Etienne

Debrecen

Varese

Amsterdam

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY

NCT02073682 - Cancer Venous Thromboembolism (VTE) | Biotech Hunter | Biotech Hunter