Deep vein thrombosis future or investigational therapies: Difference between revisions
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| Experimental: Betrixaban | | Experimental: Betrixaban | ||
| Drug: Betrixaban: Betrixaban 80 mg PO QD for 35 day + | | Drug: Betrixaban: Betrixaban 80 mg PO QD for 35 day + seven days/Enoxaparin Placebo: Once daily, 6-14 days | ||
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| Active Comparator: Enoxaparin | | Active Comparator: Enoxaparin | ||
| Drug: Enoxaparin: Enoxaparin 40 mg SC QD for 10 | | Drug: Enoxaparin: Enoxaparin 40 mg SC QD for 10 ± four days/Betrixaban Placebo: once daily, 35 days | ||
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Revision as of 02:26, 20 June 2012
Ongoing Research
Phase 3 Trials
Acute Medically Ill venous thromboembolism (VTE) Prevention With Extended Duration Betrixaban Study (The APEX Study): Sponsored by Portola Pharmaceuticals[1]
- 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 + seven days/Enoxaparin Placebo: Once daily, 6-14 days |
| Active Comparator: Enoxaparin | Drug: Enoxaparin: Enoxaparin 40 mg SC QD for 10 ± four 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 [2]
- 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 |