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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Arthroplasty, Replacement, Hip, Thrombosis

Intervention / Treatment
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* Drug: DU-176b


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 15mg BID<br>15mg edoxaban administered twice daily (BID) | Drug: DU-176b<br> <br> |
| Experimental: 30mg QD<br>30mg edoxaban administered once daily (QD) | Drug: DU-176b<br> <br> |
| Experimental: 30mg BID<br>30mg edoxaban administered twice daily (BID) | Drug: DU-176b<br> <br> |
| Experimental: 60mg QD<br>60mg edoxaban administered once daily (QD) | Drug: DU-176b<br> <br> |
| Experimental: 60mg BID<br>60mg edoxaban administered twice daily (BID) | Drug: DU-176b<br> <br> |
| Experimental: 120mg QD<br>120mg edoxaban administered once daily (QD) | Drug: DU-176b<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of Venous Thromboembolism (VTE) | 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 | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline for Prothrombin Time (PT) Results | Intent to Treat (ITT) population | end of treatment | 
| Change From Baseline for International Normalized Ratio (INR) Results | Intent to Treat (ITT) population | end of treatment | 
| Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results | Intent to Treat (ITT) population | end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Vein Thrombosis,, Anticoagulant,, Venous thromboembolic