A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery

Study Overview
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Brief Summary
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This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits.

Official Title
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A Phase IIb, Randomized, Parallel Group, Double-Blind, Double-Dummy, Multi-Center, Multi-National, Multi-Dose, Study of DU-176b Compared to Dalteparin in Patients Undergoing Elective Unilateral Total Hip Replacement

Conditions
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Thrombosis, Hip Replacement

Intervention / Treatment
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* Drug: DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor


Participation Criteria
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Eligibility Criteria
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18 years of age or older; male or female. Able to provide written informed consent. Must be scheduled for elective unilateral total hip replacement surgery. Only primary surgeries accepted. If female, must be either one year post-menopausal, surgically sterile, or using medically accepted contraceptive measures as judged by the Investigator and in accordance with local regulatory requirements.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjudicated Incidence of VTE | Assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE) from 6 to 8 hours after hip replacement surgery to 7 to 10 days after the surgery. A subject was judged to have a VTE if one or more of the following criteria were met: Observed lower extremity deep vein thrombosis (DVT) (either proximal, distal, or both ) as assessed by bilateral or unilateral ascending contrast venography prior to or at the end-of-treatment (EOT) visit Symptomatic and objectively proven pulmonary embolism prior to or at the EOT visit Symptomatic and objectively proven DVT prior to or at EOT visit end of treatment defined as 6 to 8 hours after after hip replacement surgery to 7 to 10 days after the surgery. | end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Prothrombin Time (PT) From Baseline | change in prothrombin time (PT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery | end of treatment | 
| Change in Activated Partial Thromboplastin Time (aPTT) From Baseline | change in Activated Partial Thromboplastin Time (aPTT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery | end of treatment | 
| Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events | adjudicated incidence of major or clinically relevant non-major bleeding events through 10 days after first dose | 10 days after first dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-coagulant, hip replacement, hip replacement surgery, unilateral hip replacement surgery, DeepVein Thrombosis, Venous Thromboembolism, pulmonary embolism, Prevention of Blood Clots