Deep vein thrombosis future or investigational therapies: Difference between revisions
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====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>==== | ||
* Status: Currently recruiting | |||
* Primary Outcome Measures: Venous Thromboembolic Recurrence or Death | * Primary Outcome Measures: Venous Thromboembolic Recurrence or Death | ||
* Secondary Outcome Measures: Bleeding | * Secondary Outcome Measures: Bleeding | ||
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| Active Comparator: 3 | | Active Comparator: 3 | ||
| Drug: Drug: Placebo - Tablets, Oral, twice daily, 12 months | | Drug: Drug: Placebo - Tablets, Oral, twice daily, 12 months | ||
|} | |||
====Prolonged Anticoagulation After a First Episod of Idiopathic Proximal Deep Vein Thrombosis (PADIS TVP): Sponsored by University Hospital, Brest<ref>http://clinicaltrials.gov/ct2/show/NCT00740493?term=deep+vein+thrombosis&rank=16</ref>==== | |||
* Status: Currently recruiting | |||
* Primary Outcome Measures: Symptomatic recurrent VTE and serious bleeding | |||
* Secondary Outcome Measures: Mortality due to another cause than recurrent VTE or serious bleeding | |||
* Estimated Enrollment: 374 patients | |||
* Study Start Date: July 2007 | |||
* Estimated Study Completion Date: November 2013 | |||
{| | |||
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|'''Arms''' | |||
|'''Assigned Content''' | |||
|- | |||
| Active Comparator: 1 - 18 months of active warfarin therapy | |||
| Drug: Warfarin - 18 months of warfarin therapy | |||
|- | |||
| Placebo Comparator: 2 - 18 months of placebo of warfarin | |||
| Drug: Placebo of warfarin - 18 months of placebo of warfarin therapy | |||
|} | |} | ||
Revision as of 02:45, 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]
- Status: Currently recruiting
- 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 |
Prolonged Anticoagulation After a First Episod of Idiopathic Proximal Deep Vein Thrombosis (PADIS TVP): Sponsored by University Hospital, Brest[3]
- Status: Currently recruiting
- Primary Outcome Measures: Symptomatic recurrent VTE and serious bleeding
- Secondary Outcome Measures: Mortality due to another cause than recurrent VTE or serious bleeding
- Estimated Enrollment: 374 patients
- Study Start Date: July 2007
- Estimated Study Completion Date: November 2013
| Arms | Assigned Content |
| Active Comparator: 1 - 18 months of active warfarin therapy | Drug: Warfarin - 18 months of warfarin therapy |
| Placebo Comparator: 2 - 18 months of placebo of warfarin | Drug: Placebo of warfarin - 18 months of placebo of warfarin therapy |