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

NCT00787150

Last updated date
Study Location
Pfizer Investigational Site
Nagoya, Aichi, , Japan
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Atrial FibrillationNon-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment NCT04435769
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Atrial FibrillationA Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation NCT00787150
  1. Nagoya, Aichi
  2. Seto, Aichi
  3. Touon, Ehime
  4. Kitakyushu, Fukuoka
  5. Ogaki, Gifu
  6. Isezaki, Gunma
  7. Shibukawa, Gunma
  8. Sapporo, Hokkaido
  9. Higashiibaraki-gunn Ibarakimachi, Ibaraki
  10. Zentsuji, Kagawa
  11. Kawasaki, Kanagawa
  12. Tsu, Mie
  13. Minato-ku, Tokyo
  14. Shinagawa-ku, Tokyo
  15. Shinjuku-ku, Tokyo
  16. Iwakuni, Yamaguchi
  17. Fukuoka,
  18. Kumamoto,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Atrial FibrillationApixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf) NCT03441633
  1. Barcelona, Cataluña
ALL GENDERS
0+
years
MULTIPLE SITES
Atrial FibrillationNon-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea NCT03572972
  1. Seoul,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
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 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.
Detailed Description Not 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 Date September 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 Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP