Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01491178
First received: December 12, 2011
Last updated: April 2, 2014
Last verified: April 2014

December 12, 2011
April 2, 2014
December 2011
November 2015   (final data collection date for primary outcome measure)
Incidences of adverse drug reactions [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT01491178 on ClinicalTrials.gov Archive Site
  • Incidence of systemic embolism [ Time Frame: up to 104 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of stroke [ Time Frame: up to 104 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation
Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Patients With Nonvalvular Atrial Fibrillation

To investigate the safety and efficacy of long-term use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or systemic embolism (SEE).

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

5000

Atrial Fibrillation
Drug: Prazaxa
Dabigatran etexilate
Patients with NVAF
Intervention: Drug: Prazaxa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
6100
November 2015
November 2015   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01491178
1160.130
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

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