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

Last updated on October 5, 2018

FOR MORE INFORMATION
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.
Show details

- 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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A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Atrial Fibrillation
  • 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
  • Experimental: Apixaban 5mg BID
    Intervention: Drug: Apixaban
  • Experimental: Apixaban 2.5mg BID
    Intervention: Drug: Apixaban
  • Active Comparator: Warfarin
    Intervention: Drug: Warfarin sodium
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.
 
Completed
222
September 2009
September 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00787150
B0661003
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Bristol-Myers Squibb
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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