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

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ClinicalTrials.gov Identifier: NCT01491178
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

December 12, 2011
December 13, 2011
July 26, 2017
January 30, 2018
January 30, 2018
December 12, 2011
August 2, 2016   (Final data collection date for primary outcome measure)
Frequency (Percentage) of Participants With Adverse Drug Reactions [ Time Frame: Up to 104 weeks from first administration of study drug ]
Percentage of participants with adverse drug reactions (ADRs) is presented. An ADR is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Prazaxa® Capsules either as "Related", "Probably related", or "Cannot be denied".
  • 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
Incidences of Stroke and Systemic Embolism (SEE) [ Time Frame: Up to 104 weeks from first administration of study drug ]
Incidence rate of Stroke and SEE (number of patients per 100 patient year) with 95% confidence interval (CI) is reported. Stroke and SEE were recorded as adverse events (AEs) of special interest. Exact Poisson confidence intervals are presented for incidence rate.
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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).
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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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 2, 2016
August 2, 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
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Boehringer Ingelheim
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2017