Deep vein thrombosis future or investigational therapies

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Ongoing Research

Phase 3 Trials

Acute Medically Ill venous thromboembolism (VTE) Prevention With Extended Duration Betrixaban Study (The APEX Study): Sponsored by Portola Pharmaceuticals

  • Primary Outcome Measures: Composite of VTE (Deep Vein Thrombosis (DVT) and/or Pulmonary Embolism (PE)) and VTE death
  • Secondary Outcome Measures: Number of patients with symptomatic VTE
  • Estimated Enrollment: 6,850 patients
  • Study Start Date: March 2012
  • Estimated Study Completion Date: December 2014
Arms Assigned Content
Experimental: Betrixaban Drug: Betrixaban: Betrixaban 80 mg PO QD for 35 day +7 days/Enoxaparin Placebo: Once daily, 6-14 days
Active Comparator: Enoxaparin Drug: Enoxaparin: Enoxaparin 40 mg SC QD for 10 ±4 days/Betrixaban Placebo: once daily, 35 days

Efficacy and Safety Study of Apixaban for Extended Treatment of DVT or PE: Sponsored by Bristol-Myers Squibb and Pfizer [1]

  • Primary Outcome Measures: Venous Thromboembolic Recurrence or Death
  • Secondary Outcome Measures: Bleeding
  • Estimated Enrollment: 2,430 patients
  • Study Start Date: May 2008
  • Estimated Study Completion Date: August 2012
Arms Assigned Content
Experimental: 1 - 2.5 mg Drug: Apixaban - Tablets, Oral, twice daily, 12 months (Other Name: BMS-562247)
Experimental: 2 - 5 mg Drug: Apixaban - Tablets, Oral, twice daily, 12 months (Other Name: BMS-562247)
Active Comparator: 3 Drug: Drug: Placebo - Tablets, Oral, twice daily, 12 months

References


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