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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
523
Unnamed facility
Osaka, Japan
Unnamed facility
Tokyo, Japan
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
Time frame: 2 weeks
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
Time frame: 2 weeks
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DU-176b 60 mg tablets, oral, once daily for 2 weeks
Matching placebo oral tablets, once daily for 2 weeks