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Japanese Pradaxa PMS, Long Term

NCT03175198 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5660

Last updated 2022-04-06

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2020-12-21
Completion
2021-01-12
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03175198 on ClinicalTrials.gov