Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
NCT02007655
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- Patients who are beginning to receive the treatment with this product under the approved indications, dosage, and administration will be included in this study
- Patients who are receiving Eliquis outside of its approved indication will be excluded
from this study
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- Toyama-shi, Toyama
| 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:
| |||
| 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:
| |||
| 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 | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Bristol-Myers Squibb | |||
| Verification Date | January 2019 | |||