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

Completed
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients with NVAFPrazaxa-
Primary Outcome Measures
NameTimeMethod
Frequency (Percentage) of Participants With Adverse Drug ReactionsUp 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
NameTimeMethod
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.

Trial Locations

Locations (1164)

Boehringer Ingelheim Investigational Site 1

🇯🇵

Abashiri, Hokkaido, Japan

Boehringer Ingelheim Investigational Site 287

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Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 288

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Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 289

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Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 290

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Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 291

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Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 292

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Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 1141

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Aira,Kagoshima, Japan

Boehringer Ingelheim Investigational Site 622

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Aisai,Aichi, Japan

Boehringer Ingelheim Investigational Site 111

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Aizuwakamatsu,Fukushima, Japan

Scroll for more (1154 remaining)
Boehringer Ingelheim Investigational Site 1
🇯🇵Abashiri, Hokkaido, Japan

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