Conditions: Arthroplasty, Replacement, Hip Thrombosis
Keywords: Deep Vein Thrombosis, Anticoagulant, Venous thromboembolic
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 606
Healthy volunteers: no

Brief summary:
Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.

Detailed description:
The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.

Arms:
arm 1: 15mg edoxaban administered twice daily (BID) arm 2: 30mg edoxaban administered once daily (QD) arm 3: 30mg edoxaban administered twice daily (BID) arm 4: 60mg edoxaban administered once daily (QD) arm 5: 60mg edoxaban administered twice daily (BID) arm 6: 120mg edoxaban administered once daily (QD)

Interventions: intervention 1: DU-176b
Intervention descriptions: intervention 1: None

Protocol document: