Title
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
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)
Phase
Phase 2Lead Sponsor
Daiichi SankyoStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Venous Thromboembolism Deep Vein Thrombosis Total Knee ArthroplastyIntervention/Treatment
edoxaban ...Study Participants
523The 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.
DU-176b 5mg tablets oral, once daily for 2 weeks
DU-176b 15mg tablets, oral once daily for 2 weeks
DU-176b 30 mg tablets, oral, once daily for 2 weeks
DU-176b 60 mg tablets, oral, once daily for 2 weeks
Matching placebo oral tablets, once daily for 2 weeks
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
| Event Type | Organ System | Event Term | DU-176b 5 mg | DU-176b 15 mg | DU-176b 30 mg | DU-176b 60 mg | Placebo |
|---|
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
Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. Related to the study drug
