A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
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|ClinicalTrials.gov Identifier: NCT01203098|
Recruitment Status : Completed
First Posted : September 16, 2010
Results First Posted : February 9, 2015
Last Update Posted : February 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolism Thromboembolism Thrombosis Embolism and Thrombosis Deep Vein Thrombosis Arthroplasty, Replacement, Hip||Drug: DU-176b 15mg Drug: DU-176b 30mg Drug: Enoxaparin sodium 20 mg (=2000IU)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||264 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2b, Randomized, Multi-Dose Efficacy,Safety Study of the Oral Factor Xa Inhibitor DU-176b Versus Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-2)|
|Study Start Date :||July 2008|
|Primary Completion Date :||December 2008|
|Study Completion Date :||June 2009|
Experimental: DU-176b 30mg once daily
DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery
Drug: DU-176b 30mg
DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery.
Other Name: edoxaban
Active Comparator: Enoxaparin sodium twice daily
Enoxaparin sodium 20mg (=2000IU) / 0.2mL twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery
Drug: Enoxaparin sodium 20 mg (=2000IU)
Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.
Experimental: DU-176b 15mg once daily
DU-176b 15mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery
Drug: DU-176b 15mg
DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery.
Other Name: edoxaban
- Percentage 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 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 Bleedings. [ 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): NCT01203098
|Principal Investigator:||Takeshi Fuji||Osaka Koseinenkin Hospital|