At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 222 enrolled
Drug / intervention
Apixaban +2 moredrug
Likely dose
Apixaban 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b, Randomized, Partially Blind (Open Label Warfarin), Active-Controlled (Warfarin), Multicenter Study, To Evaluate The Safety And Efficacy In 2 Doses Of Apixaban In Comparison To Warfarin, Administered For 12 Weeks In Subjects With NVAF
In Brief
A Phase 2 clinical trial evaluating Apixaban and Warfarin sodium for Atrial Fibrillation. Completed, enrolled 222 participants across 18 sites.
Detailed Summary
To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesJapan
CollaboratorsBristol-Myers Squibb
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedNov 2008
Primary CompletionSep 2009
TodayJul 2026
First PostedNov 7, 2008
Enrollment StartJun 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.7 years ago
Interventions
Apixabandrug
Apixaban 5 mg tablet BID for 12 weeks
Apixabandrug
Apixaban 2.5 mg tablet BID for 12 weeks
Warfarin sodiumdrug
At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks