Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation
- Conditions
- Atrial Fibrillation
- Interventions
- Drug: Prazaxa
- Registration Number
- NCT01491178
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6772
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with NVAF Prazaxa -
- Primary Outcome Measures
Name Time Method Frequency (Percentage) of Participants With Adverse Drug Reactions 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".
- Secondary Outcome Measures
Name Time Method Incidences of Stroke and Systemic Embolism (SEE) 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.
Related Research Topics
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Trial Locations
- Locations (1164)
Boehringer Ingelheim Investigational Site 1
🇯🇵Abashiri, Hokkaido, Japan
Boehringer Ingelheim Investigational Site 287
🇯🇵Adachi,Tokyo, Japan
Boehringer Ingelheim Investigational Site 288
🇯🇵Adachi,Tokyo, Japan
Boehringer Ingelheim Investigational Site 289
🇯🇵Adachi,Tokyo, Japan
Boehringer Ingelheim Investigational Site 290
🇯🇵Adachi,Tokyo, Japan
Boehringer Ingelheim Investigational Site 291
🇯🇵Adachi,Tokyo, Japan
Boehringer Ingelheim Investigational Site 292
🇯🇵Adachi,Tokyo, Japan
Boehringer Ingelheim Investigational Site 1141
🇯🇵Aira,Kagoshima, Japan
Boehringer Ingelheim Investigational Site 622
🇯🇵Aisai,Aichi, Japan
Boehringer Ingelheim Investigational Site 111
🇯🇵Aizuwakamatsu,Fukushima, Japan
Scroll for more (1154 remaining)Boehringer Ingelheim Investigational Site 1🇯🇵Abashiri, Hokkaido, Japan