At a glance
ClinicalIndex Comparison RecordN/ACompleted· 5,660 enrolled
Drug / intervention
Prazaxa® Capsulesdrug
Likely dose
Prazaxa® Capsules 300 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post-Marketing Surveillance on the Use of Prazaxa® Capsules in Japanese Patients With Nonvalvular Atrial Fibrillation After the Availability of Idarucizumab
In Brief
An observational study evaluating Prazaxa® Capsules for Atrial Fibrillation. Completed, enrolled 5,660 participants across 1 site.
Detailed Summary
The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 2017
Enrollment StartJul 2017
Primary CompletionDec 2020
Study CompletionJan 2021
TodayJul 2026
First PostedJun 5, 2017
Enrollment StartJul 5, 2017
Primary CompletionDec 21, 2020
Study CompletionJan 12, 2021
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 9.1 years ago
Interventions
Prazaxa® Capsulesdrug
Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg \[as 2 capsules of 75 mg\] twice a day (b.i.d)) or 220 mg (110 mg \[as 1 capsule of 110 mg\] b.i.d) for a treatment duration of 52 weeks.