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Post-Marketing Surveillance of Prazaxa on the Long-term Use

This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01491178
First received: December 12, 2011
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

In Japan, post-approval execution of post-marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for re-examination. Reexamination period is defined by the J-PAL. Eight years after approval of a new substance, results of PMS need to be submitted as a part of re-examination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare.


Condition Intervention
Atrial Fibrillation
 Drug: Prazaxa

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance on the Long-Term Use of Prazaxa Capsules in Patients With Nonvalvular Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Incidences of adverse drug reactions [ Time Frame: up to 104 weeks ] [ Designated as safety issue: Yes ]
  • Serious adverse events [ Time Frame: up to 104 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of the following adverse events of special interest - Haemorrhage and bleeding - Myocardial infarction - Gastrointestinal disorder [ Time Frame: up to 104 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 6100
Study Start Date: December 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with NVAF Drug: Prazaxa
Dabigatran etexilate

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

5000

Criteria

Inclusion criteria:

- Patients with nonvalvular atrial fibrillation who have never received Prazaxa Capsules for preventing the occurrence of ischemic stroke and systemic embolism will be included.

Exclusion criteria:

- None

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491178

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Show 911 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01491178     History of Changes
Other Study ID Numbers: 1160.130
Study First Received: December 12, 2011
Last Updated: May 2, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013