Japanese Pradaxa PMS, Long Term

February 3, 2022 updated by: Boehringer Ingelheim

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

5660

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Nippon Boehringer Ingelheim Co., Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

An observational study, no specific treatment is mandated or withheld from the patients. The choice of maintenance treatment for nonvalvular atrial fibrillation must be according to regular medical practice and at discretion of physician (i.e., no randomised assignment of patient to treatment [Prazaxa® Capsules or other treatment] is performed).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with nonvalvular atrial fibrillation (NVAF)
Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). 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.
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.
Other Names:
  • Dabigatran etexilate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
Time Frame: From baseline till the last administration + 6 days. Up to 364 days.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

  • Study Chair: Rie Ikeda, 81364172200, zzCDMJP_PV_PMS@boehringer-ingelheim.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2017

Primary Completion (Actual)

December 21, 2020

Study Completion (Actual)

January 12, 2021

Study Registration Dates

First Submitted

June 1, 2017

First Submitted That Met QC Criteria

June 1, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160-0284

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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