A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Phase 3, Randomized, Double-Blind, Double-Dummy Efficacy and Safety Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS E-3 Trial)|
- Incidence of Subjects With Venous Thromboembolism Events. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
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 Deep Vein Thrombosis (DVT) confirmed by unilateral venography at the end of study treatment
- Definite diagnosis of symptomatic Pulmonary Embolism (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 venous Thromboembolism (VTE)
- Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery.
Active Comparator: enoxaparin sodium
enoxaparin sodium 20mg (=2000IU) 0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery.
|Drug: enoxaparin sodium|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181102
|Principal Investigator:||Takeshi Fuji||Osaka Koseinenkin Hospital|