CLINICAL TRIALS PROFILE FOR BETRIXABAN
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All Clinical Trials for BETRIXABAN
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00375609 ↗ | Factor Xa Inhibitor, PRT054021, Against Enoxaparin for the Prevention of Venous Thromboembolic Events (EXPERT) | Completed | Portola Pharmaceuticals | Phase 2 | 2006-05-01 | Randomized study of PRT054021 40 mg and 15 mg bid vs. enoxaparin 30 mg q12h for the prophylaxis of venous thromboembolic events after unilateral knee replacement surgery. |
| NCT00742859 ↗ | Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin | Completed | Portola Pharmaceuticals | Phase 2 | 2008-10-01 | Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the advantage of not requiring dose adjustments due to international normalized ratios (INRs) outside the target range of 2.0 to 3.0 and a more consistent level of anticoagulation over time. |
| NCT00999336 ↗ | A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment | Completed | Merck Sharp & Dohme Corp. | Phase 1 | 2009-07-01 | The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers. |
| NCT00999336 ↗ | A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment | Completed | Portola Pharmaceuticals | Phase 1 | 2009-07-01 | The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers. |
| NCT01229254 ↗ | Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter | Completed | Portola Pharmaceuticals | Phase 2 | 2010-09-01 | The primary purpose of this study is to optimize drug exposure in the target population. |
| NCT01229254 ↗ | Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter | Completed | Merck Sharp & Dohme Corp. | Phase 2 | 2010-09-01 | The primary purpose of this study is to optimize drug exposure in the target population. |
| NCT01583218 ↗ | Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study) | Completed | Portola Pharmaceuticals | Phase 3 | 2012-03-01 | The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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