Deep vein thrombosis future or investigational therapies: Difference between revisions
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* Primary Outcome Measures: Composite of VTE (DVT and/or PE) and VTE death | * Primary Outcome Measures: Composite of VTE (DVT and/or PE) and VTE death | ||
* Secondary Outcome Measures: Number of patients with symptomatic VTE | * Secondary Outcome Measures: Number of patients with symptomatic VTE | ||
* Estimated Enrollment: | * Estimated Enrollment: 6,850 patients | ||
* Study Start Date: March 2012 | * Study Start Date: March 2012 | ||
* Estimated Study Completion Date: | * 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 [[Deep Vein Thrombosis]] or [[Pulmonary Embolism]]: 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 [[Deep Vein Thrombosis]] or [[Pulmonary Embolism]]: Sponsored by Bristol-Myers Squibb and Pfizer <ref>http://clinicaltrials.gov/ct2/show/NCT00633893</ref> | ||
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* Study Start Date: May 2008 | * Study Start Date: May 2008 | ||
* Estimated Study Completion Date: August 2012 | * 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: Apixaban - Tablets, Oral, twice daily, 12 months (Other Name: BMS-562247) | |||
|} | |||
==References== | ==References== | ||
Revision as of 02:07, 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
- Primary Outcome Measures: Composite of VTE (DVT and/or 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 Deep Vein Thrombosis or Pulmonary Embolism: 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: Apixaban - Tablets, Oral, twice daily, 12 months (Other Name: BMS-562247) |