A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT01181102|
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : February 19, 2015
Last Update Posted : February 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolism||Drug: edoxaban Drug: enoxaparin sodium||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||716 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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)|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||February 2010|
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|
- Incidence of Subjects With Venous Thromboembolism Events. [ Time Frame: 2 weeks ]
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181102
|Principal Investigator:||Takeshi Fuji||Osaka Koseinenkin Hospital|