Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Darexaban; Enoxaparin; Factor Xa Inhibitors

Criteria

Inclusion Criteria:

• Scheduled for elective primary total knee replacement surgery

• Legal minimum age requirement ( country-specific)

• Written informed consent has been obtained

Exclusion Criteria:

• Documented history or considered to be at increased risk of venous thromboembolism

• Subjects considered to be at increased risk of bleeding:

• Known hemorrhagic disorder and/or coagulation disorder

• Thrombocytopenia

• Clinically important bleeding occurred within 3 months prior to the screening visit

• Acute bacterial endocarditis

• Severe hypertension

• Retinopathy

• Concomitant use of anticoagulants / antiplatelet agents (including homeopathic drugs) and/or anticipated postoperative need for other reasons than prevention of DVT during the study period.