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Apixaban 2.5 milligram

Phase 2

Atrial Fibrillation | Small molecule | Cardiovascular |Baxter International Inc.|Last Updated: Sep 21, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04952792Study of Apixaban in Patients Receiving HemodiafiltrationPHASE2 COMPLETED 11May 20, 2021Dec 15, 2022Sep 21, 20231 Spain
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Study Endpoints
Primary Endpoints
Blood plasma concentrations of Apixaban before, during and after renal replacement therapy
28 days

Determine the plasma concentrations of apixaban before, during and after renal replacement therapy (hemodialysis and hemodiafiltration)

Secondary Endpoints
Urine plasma concentrations of Apixaban before, during and after renal replacement therapy
28 days
Anti-Factor Xa activity of apixaban (heparin activity (IU/mL))
28 days
Number of patients with medical complications with medical complications not directly related to the underlying disease.
28 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ApixabanEXPERIMENTALApixaban treatment, oral, 2.5 mg/12h, 28 days
Interventions
NameTypeDescription
Apixaban 2.5 milligram Oral TabletDRUGApixaban 2.5mg/12h, oral, 28 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Adults (18 years or older). * Body weight ≥ 60 kg. * Diagnosis of chronic kidney disease on hemodialysis, clinically stable (with a minimum of 3 months of treatment) and nonvalvular atrial fibrillation in treatment with coumarins. * Patient candidate for change of anticoagulant...

Countries:Spain
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