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Last Updated: May 10, 2021

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CLINICAL TRIALS PROFILE FOR BETRIXABAN

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All Clinical Trials for Betrixaban

Trial ID Title Status Sponsor Phase Start Date Summary
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 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 (Study MK-4448-006) 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 (Study MK-4448-006) 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.
NCT01765868 A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers Completed Portola Pharmaceuticals Phase 1 2007-09-01 This is a open label, single center, single oral dose, study of PRT054021, in healthy subjects.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Betrixaban

Condition Name

Condition Name for Betrixaban
Intervention Trials
Atrial Fibrillation 2
Hepatic Impairment 1
Healthy Subjects 1
Healthy 1
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Condition MeSH

Condition MeSH for Betrixaban
Intervention Trials
Atrial Fibrillation 2
Renal Insufficiency 1
Liver Diseases 1
Venous Thromboembolism 1
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Clinical Trial Locations for Betrixaban

Trials by Country

Trials by Country for Betrixaban
Location Trials
United States 43
Canada 6
Spain 6
Australia 4
South Africa 3
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Trials by US State

Trials by US State for Betrixaban
Location Trials
California 3
Florida 3
Maryland 2
Illinois 2
Colorado 2
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Clinical Trial Progress for Betrixaban

Clinical Trial Phase

Clinical Trial Phase for Betrixaban
Clinical Trial Phase Trials
Phase 3 1
Phase 2 3
Phase 1 5
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Clinical Trial Status

Clinical Trial Status for Betrixaban
Clinical Trial Phase Trials
Completed 7
Not yet recruiting 1
Recruiting 1
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Clinical Trial Sponsors for Betrixaban

Sponsor Name

Sponsor Name for Betrixaban
Sponsor Trials
Portola Pharmaceuticals 9
Merck Sharp & Dohme Corp. 2
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Sponsor Type

Sponsor Type for Betrixaban
Sponsor Trials
Industry 11
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