Study identification

PURI

https://redirect.ema.europa.eu/resource/25630

EU PAS number

EUPAS7591

Study ID

25630

Official title and acronym

Evaluation of potential off-label use of dabigatran etexilate in Europe

DARWIN EU® study

No

Study countries

Denmark
France
United Kingdom

Study description

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).

Study status

Finalised
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
InstitutionNot-for-profitENCePP partner

Contact details

Manel Pladevall-Vila

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim GmbH
Study protocol
Initial protocol

1160-144--protocol-revision-04_redacted

English (1.66 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)