Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement

A Phase IIa, Multi-center, Multi-national, Open Label, Dose Ranging Study of the Efficacy, Safety, and Tolerability of Oral DU-176b Administered Once or Twice Daily in the Treatment of Adult Patients Undergoing Total Hip Arthroplasty

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.

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.

Inclusion Criteria:

• Unilateral hip replacement

Exclusion Criteria:

• Patients scheduled for bilateral hip replacement in same procedure
• Patients with increased risk of bleeding
• Uncontrolled hypertension (BP greater than 180/100 mmHg)
• Patients less than 111 lbs or more than 243 lbs
• Patients on long-term anticoagulants
• Patients with contraindications to venography
• Patients with medical history of venous thromboembolism
• Patients with impaired hepatic function
• Known to be pregnant
• Lactating women