Conditions: Venous Thromboembolism Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Thromboembolism Venous Thrombosis
Keywords: Recurrent Thrombosis Recurrent Pulmonary Embolism Symptomatic Deep Vein Thrombosis Symptomatic Pulmonary Embolism Venous Thromboembolism (VTE)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 8292
Healthy volunteers: no

Brief summary:
Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: edoxaban tosylate(DU-176b) intervention 2: low molecular weight heparin/unfractionated heparin intervention 3: warfarin
Intervention descriptions: intervention 1: edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment intervention 2: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.

Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment intervention 3: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment

Protocol document: