Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

NCT02007655

Last updated date
Study Location
Local Institution
Toyama-shi, Toyama, 930-0194, 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.
NonValvular Atrial Fibrillation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients who are beginning to receive the treatment with this product under the approved indications, dosage, and administration will be included in this study

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


- Patients who are receiving Eliquis outside of its approved indication will be excluded
from this study

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

NonValvular Atrial FibrillationEliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
NCT02007655
  1. Toyama-shi, Toyama
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
Official Title Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
Brief Summary

The primary objectives of this study are:

  • To estimate the incidence rate of unexpected adverse events
  • To characterize the bleeding events and assess risk factors of bleeding
  • To identify ancillary baseline variables that may also be associated with adverse outcomes
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population University hospitals, general hospitals, and clinics that have relevant departments, such as cardiology, cerebrovascular medicine, neurology, internal medicine, neurosurgery, etc, where the surveillance drug is mainly prescribed
Condition NonValvular Atrial Fibrillation
Intervention Drug: Eliquis
Other Names:
  • Apixaban
  • BMS-562247
Study Groups/Cohorts Eliquis on Nonvalvular Atrial Fibrilliation patients
Patients who are beginning to receive the treatment with Eliquis under the approved indications, dosage, and administration will be included in this study
Intervention: Drug: Eliquis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: December 10, 2013)
5500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date August 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Patients who are beginning to receive the treatment with this product under the approved indications, dosage, and administration will be included in this study

Exclusion Criteria:

  • Patients who are receiving Eliquis outside of its approved indication will be excluded from this study
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02007655
Other Study ID Numbers CV185-286
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators Pfizer
Investigators
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date January 2019