Efficacy and Safety of TAK-442 in Subjects Undergoing Total Knee Replacement
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Phase 2, Randomized, Active Comparator-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-442 in Subjects Undergoing Total Knee Replacement|
- Composite evaluation of All-Cause Mortality, Symptomatic and Asymptomatic Deep Vein Thrombosis and Symptomatic Pulmonary Embolism. [ Time Frame: Day 10. ]
- Incidence of Major Bleeding. [ Time Frame: Day 10. ]
- Evaluation of Major Venous Thromboembolism (composite of Symptomatic or Asymptomatic Proximal Deep Vein Thrombosis, Symptomatic Objectively Confirmed Pulmonary Embolism, and Venous Thromboembolism-Related Death). [ Time Frame: Day 10. ]
- Evaluation of Symptomatic Venous Thromboembolism. [ Time Frame: Day 10. ]
- Evaluation of Proximal Deep Vein Thrombosis. [ Time Frame: Day 10. ]
- Evaluation of Distal Deep Vein Thrombosis. [ Time Frame: Day 10. ]
- Evaluation of clinically significant Non-Major Bleeding events. [ Time Frame: Day 10. ]
- Evaluation of Minor Bleeding events. [ Time Frame: Day 10. ]
|Study Start Date:||October 2007|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
|Experimental: TAK-442 40 mg QD||
TAK-442 40 mg, tablets, orally, once daily for up to 10 days.
|Experimental: TAK-442 80 mg QD||
TAK-442 80 mg, tablets, orally, once daily for up to 10 days.
|Experimental: TAK-442 10 mg BID||
TAK-442 10 mg, tablets, orally, twice daily for up to 10 days.
|Experimental: TAK-442 20 mg BID||
TAK-442 20 mg, tablets, orally, twice daily for up to 10 days.
|Experimental: TAK-442 40 mg BID||
TAK-442 40mg, tablets, orally, twice daily for up to 10 days.
|Experimental: TAK-442 80 mg BID||
TAK-442 80 mg, tablets, orally, twice daily for up to 10 days.
|Active Comparator: Enoxaparin 30 mg BID||
Enoxaparin 30 mg, syringe, subcutaneous injection, twice daily for up to 10 days.
Takeda Global Research & Development Center, Inc. is developing the compound TAK-442 as a candidate for the secondary prevention of atherothrombotic events in patients with acute coronary syndromes. TAK-442 is an oral inhibitor of activated factor X within the blood coagulation cascade.
Due to its critical role in propagating the coagulation cascade, activated factor X is now considered to be a therapeutic aim in the development of anticoagulant drugs. Therefore activated factor X inhibitors, are among the agents under investigation as treatments for the spectrum of thromboembolic diseases involving either the arterial or the venous system.
Short term anticoagulation is often used for the prevention of venous thromboembolism. Patients undergoing major orthopedic surgery are at particularly high risk of venous thromboembolism after surgery. Consequently, such patients are routinely given anticoagulant medication after surgery. Although parenteral (injectable) drugs, such as enoxaparin or fondaparinux, can be used for this indication, the need for subcutaneous injection is problematic once patients are discharged from hospital. With the push for shorter hospital stays, this issue is of increasing concern. Therefore, there is a need for new oral anticoagulants. Although warfarin can be used for out of hospital prophylaxis, the need for coagulation monitoring and dose adjustments complicates its use. The new oral anticoagulants have the potential to overcome this problem because they can be given in fixed doses without the need for coagulation monitoring.
The purpose of the current study is to evaluate the antithrombotic effect of TAK-442 in patients undergoing elective total knee replacement surgery. This study will be the first TAK-442 trial in patients.
Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be approximately 2.25 months. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations, electrocardiograms and bilateral venogram. Outside of the study center, participants randomized to enoxaparin will be required to administer study medication subcutaneously with a syringe.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641732
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|Study Director:||Executive Medical Director Clinical Science||Takeda|