A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Apixaban
NCT ID: NCT02207725
Last Updated: 2023-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
68 participants
INTERVENTIONAL
2014-03-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Andexanet
Andexanet (antidote)
Andexanet
Placebo
Placebo
Placebo
Interventions
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Andexanet
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of thrombosis or risk factors for thrombosis
* History of adult asthma or use of inhaled medications
50 Years
75 Years
ALL
Yes
Sponsors
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Portola Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Vandana Mathur, M.D.
Role: STUDY_DIRECTOR
Portola Pharmaceuticals
Locations
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Celerion
Tempe, Arizona, United States
Countries
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References
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Siegal DM, Curnutte JT, Connolly SJ, Lu G, Conley PB, Wiens BL, Mathur VS, Castillo J, Bronson MD, Leeds JM, Mar FA, Gold A, Crowther MA. Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity. N Engl J Med. 2015 Dec 17;373(25):2413-24. doi: 10.1056/NEJMoa1510991. Epub 2015 Nov 11.
Other Identifiers
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14-503
Identifier Type: -
Identifier Source: org_study_id
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