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A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Nagoya, Aichi, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrial Fibrillation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Age ≥ 20 years outpatient (regardless of sex)

- Patients diagnosed as non-valvular atrial fibrillation (NVAF)

- One or more following risks of stroke.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00787150
Pfizer
Completed
A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation

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Descriptive Information
Brief Title  ICMJE A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation
Official Title  ICMJE 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
Brief SummaryTo 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Drug: Apixaban
    Apixaban 5 mg tablet BID for 12 weeks
  • Drug: Apixaban
    Apixaban 2.5 mg tablet BID for 12 weeks
  • Drug: Warfarin sodium
    At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks
Study Arms  ICMJE
  • Experimental: Apixaban 5mg BID
    Intervention: Drug: Apixaban
  • Experimental: Apixaban 2.5mg BID
    Intervention: Drug: Apixaban
  • Active Comparator: Warfarin
    Intervention: Drug: Warfarin sodium
Publications *Ogawa S, Shinohara Y, Kanmuri K. Safety and efficacy of the oral direct factor xa inhibitor apixaban in Japanese patients with non-valvular atrial fibrillation. -The ARISTOTLE-J study-. Circ J. 2011;75(8):1852-9. Epub 2011 Jun 14.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2009)
222
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2008)
250
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion DateSeptember 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ? 20 years outpatient (regardless of sex)
  • Patients diagnosed as non-valvular atrial fibrillation (NVAF)
  • One or more following risks of stroke.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00787150
Other Study ID Numbers  ICMJE B0661003
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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