Japanese Pradaxa PMS, Long Term

Atrial Fibrillation Clinical Trial

Official title:

Post-Marketing Surveillance on the Use of Prazaxa® Capsules in Japanese Patients With Nonvalvular Atrial Fibrillation After the Availability of Idarucizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175198
• Other study ID #: 1160-0284
• Status: Completed
• Start date: July 5, 2017
• Est. completion date: January 12, 2021

Study information

• Verified date: February 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab

Description:

The study is Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Japanese patients with nonvalvular atrial fibrillation after the availability of idarucizumab. Even after the availability of idarucizumab in real clinical practice, appropriate use of Prazaxa® Capsules will continue. The patient population who receive Prazaxa® Capsules and the safety profile of Prazaxa® Capsules is not expected to change. This study investigates appropriate use with prospective investigation in the routine medical practice

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5660
• Est. completion date: January 12, 2021
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients with nonvalvular atrial fibrillation who have never received Prazaxa® Capsules / dabigatran etexilate for preventing the occurrence of ischemic stroke and systemic embolism before enrolment in Japan

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Prazaxa® Capsules
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.

Locations

Country	Name	City	State
Japan	Nippon Boehringer Ingelheim Co., Ltd	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)	Percentage of patients with suspected adverse drug reactions (ADRs). An adverse drug reaction is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility.; Percentages were pre-specified to be rounded to two decimal places.	From baseline till the last administration + 6 days. Up to 364 days.

External Links

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