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
Overview
- Phase
- Phase 2
- Intervention
- DU-176b
- Conditions
- Arthroplasty, Replacement, Hip
- Sponsor
- Daiichi Sankyo
- Enrollment
- 606
- Locations
- 1
- Primary Endpoint
- Prevention of Venous Thromboembolism (VTE)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
15mg BID
15mg edoxaban administered twice daily (BID)
Intervention: DU-176b
30mg QD
30mg edoxaban administered once daily (QD)
Intervention: DU-176b
30mg BID
30mg edoxaban administered twice daily (BID)
Intervention: DU-176b
60mg QD
60mg edoxaban administered once daily (QD)
Intervention: DU-176b
60mg BID
60mg edoxaban administered twice daily (BID)
Intervention: DU-176b
120mg QD
120mg edoxaban administered once daily (QD)
Intervention: DU-176b
Outcomes
Primary Outcomes
Prevention of Venous Thromboembolism (VTE)
Time Frame: 2 weeks
The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment (approximately 2 weeks post surgery). Confirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography
Secondary Outcomes
- Change From Baseline for Prothrombin Time (PT) Results(end of treatment)
- Change From Baseline for International Normalized Ratio (INR) Results(end of treatment)
- Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results(end of treatment)