A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

Study Overview
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Brief Summary
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The objective of this study is to assess the efficacy, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.

Official Title
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A Phase 2b, Randomized, Double-Blind, Multi-Dose Efficacy, Safety and Dose-finding Study of the Oral Factor Xa Inhibitor DU-176b Compared With Placebo for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS J-1)

Conditions
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Venous Thromboembolism, Deep Vein Thrombosis, Total Knee Arthroplasty

Intervention / Treatment
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* Drug: DU-176b
* Drug: DU-176b
* Drug: DU-176b
* Drug: DU-176b
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing unilateral total knee arthroplasty Exclusion Criteria: risks of hemorrhage thromboembolic risks weight less than 40 kg pregnant, suspect pregnancy, or subjects who want to become pregnant

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 84 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DU-176b 5 mg<br> | Drug: DU-176b<br>* DU-176b 5mg tablets oral, once daily for 2 weeks<br>* Other names: edoxaban;|
| Experimental: DU-176b 15 mg<br> | Drug: DU-176b<br>* DU-176b 15mg tablets, oral once daily for 2 weeks<br>* Other names: edoxaban;|
| Experimental: DU-176b 30 mg<br> | Drug: DU-176b<br>* DU-176b 30 mg tablets, oral, once daily for 2 weeks<br>* Other names: edoxaban;|
| Experimental: DU-176b 60 mg<br> | Drug: DU-176b<br>* DU-176b 60 mg tablets, oral, once daily for 2 weeks<br>* Other names: edoxaban;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching placebo oral tablets, once daily for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Venous Thromboembolism Events. | 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. Lower extremity DVT confirmed by bilateral venography at the end of study treatment Definite diagnosis of symptomatic PE Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding | Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. Related to the study drug | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, venous thromboembolism, edoxaban, factor Xa