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Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe

NCT ID: NCT02240654

Last Updated: 2017-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36573 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-28

Study Completion Date

2016-05-20

Brief Summary

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This is a descriptive, observational, multi-country European cross-sectional study of new users of dabigatran etexilate that aims to characterise on- and off-label status and other medical characteristics at the time of the first captured prescription of dabigatran etexilate in each database. The study will be conducted using Cegedim Strategic Database (CSD, France), Danish National Databases (Denmark) and Clinical Practice Research Datalink (CPRD, UK).

Detailed Description

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Study Design:

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Dabigatran etexilate

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Have at least 1 year of enrolment in the electronic database.
2. Have not been prescribed dabigatran etexilate during the 1-year period prior to the index date.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1160.144.1 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

Countries

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Spain

References

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Cainzos-Achirica M, Varas-Lorenzo C, Pottegard A, Asmar J, Plana E, Rasmussen L, Bizouard G, Forns J, Hellfritzsch M, Zint K, Perez-Gutthann S, Pladevall-Vila M. Methodological challenges when evaluating potential off-label prescribing of drugs using electronic health care databases: A case study of dabigatran etexilate in Europe. Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):713-723. doi: 10.1002/pds.4416. Epub 2018 Mar 23.

Reference Type DERIVED
PMID: 29570897 (View on PubMed)

Other Identifiers

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1160.144

Identifier Type: -

Identifier Source: org_study_id