Deep vein thrombosis future or investigational therapies: Difference between revisions
Jump to navigation
Jump to search
| Line 9: | Line 9: | ||
* Study Start Date: March 2012 | * Study Start Date: March 2012 | ||
* Estimated Study Completion Date: December 2014 | * Estimated Study Completion Date: December 2014 | ||
<table> | |||
<tr> | |||
<td>'''Arms'''</td> | |||
<td>'''Assigned Content'''</td> | |||
</tr> | |||
<tr> | |||
<td>Experimental: Betrixaban</td> | |||
<td>Drug: Betrixaban: Betrixaban 80 mg PO QD for 35 day + seven days/Enoxaparin Placebo: Once daily, 6-14 days</td> | |||
</tr> | |||
<tr> | |||
<td>Active Comparator: Enoxaparin</td> | |||
<td>Drug: Enoxaparin: Enoxaparin 40 mg SC QD for 10 ± four days/Betrixaban Placebo: once daily, 35 days</td> | |||
</tr> | |||
</table> | |||
====Efficacy and Safety Study of Apixaban for Extended Treatment of DVT or PE: Sponsored by Bristol-Myers Squibb and Pfizer <ref>http://clinicaltrials.gov/ct2/show/NCT00633893</ref>==== | ====Efficacy and Safety Study of Apixaban for Extended Treatment of DVT or PE: Sponsored by Bristol-Myers Squibb and Pfizer <ref>http://clinicaltrials.gov/ct2/show/NCT00633893</ref>==== | ||
Revision as of 02:31, 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 |