Japanese Pradaxa PMS, Long Term

NCT03175198 | Completed Results FDA Drug

• 1 other identifier: 1160-0284
• Study Type: observational
• Target: 5,660
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

Prazaxa® Capsules DRUG

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.

Also known as: Dabigatran etexilate

Patients with nonvalvular atrial fibrillation (NVAF)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Nippon Boehringer Ingelheim Co., Ltd

Tokyo, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Rie Ikeda, 81364172200

  zzCDMJP_PV_PMS@boehringer-ingelheim.com

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 5, 2017
• Study Start: July 5, 2017
• Primary Completion: December 21, 2020
• Study Completion: January 12, 2021
• Last Updated: April 6, 2022
• Results First Posted: April 6, 2022

Record last verified: 2022-02

Locations

JP (1)