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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01491178
First received: December 12, 2011
Last updated: February 16, 2017
Last verified: February 2017
December 12, 2011
February 16, 2017
December 2011
August 2016   (Final data collection date for primary outcome measure)
Incidences of adverse drug reactions [ Time Frame: up to 104 weeks ]
  • Incidences of adverse drug reactions [ Time Frame: up to 104 weeks ]
  • Serious adverse events [ Time Frame: up to 104 weeks ]
  • Incidence of the following adverse events of special interest - Haemorrhage and bleeding - Myocardial infarction - Gastrointestinal disorder [ Time Frame: up to 104 weeks ]
Complete list of historical versions of study NCT01491178 on ClinicalTrials.gov Archive Site
  • Incidence of systemic embolism [ Time Frame: up to 104 weeks ]
  • Incidence of stroke [ Time Frame: up to 104 weeks ]
Not Provided
Not Provided
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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
Inoue H, Uchiyama S, Atarashi H, Okumura K, Koretsune Y, Yasaka M, Yamashita T, Ohnishi M, Yagi N, Fukaya T; J-Dabigatran Surveillance Investigators. Post-marketing surveillance on the long-term use of dabigatran in Japanese patients with nonvalvular atrial fibrillation: Preliminary report of the J-dabigatran surveillance. J Arrhythm. 2016 Apr;32(2):145-50. doi: 10.1016/j.joa.2015.11.008. Epub 2016 Jan 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6772
August 2016
August 2016   (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

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01491178
1160.130
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
February 2017

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