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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
606
Local Institution
Decatur, Georgia, United States
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
Time frame: 2 weeks
Change From Baseline for Prothrombin Time (PT) Results
Intent to Treat (ITT) population
Time frame: end of treatment
Change From Baseline for International Normalized Ratio (INR) Results
Intent to Treat (ITT) population
Time frame: end of treatment
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results
Intent to Treat (ITT) population
Time frame: end of treatment
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