Status:
COMPLETED
A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Age ≥ 20 years outpatient (regardless of sex)
- Patients diagnosed as non-valvular atrial fibrillation (NVAF)
- One or more following risks of stroke.
Exclusion
- Recent cerebral infarction (includes TIA) within 4 weeks of week 0.
- Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included).
- Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT00787150
Start Date
June 1 2008
End Date
September 1 2009
Last Update
May 1 2013
Active Locations (18)
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1
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
2
Pfizer Investigational Site
Seto, Aichi-ken, Japan
3
Pfizer Investigational Site
Touon, Ehime, Japan
4
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan