Status: Finalised First registered on: 08/10/2014
Last updated on: 20/09/2018
1. Study identification
EU PAS Register NumberEUPAS7591
Official titleEvaluation of potential off-label use of dabigatran etexilate in Europe
Study title acronym
Study typeObservational study
Brief description of the studyThis 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).
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagewww.rtihs.org
Details of (Primary) lead investigator
Title Dr
Last name Pladevall-Vila
First name Manel
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4

CPRD
University of Southern Denmark Pharmacoepi center
RTI-HS
CSD MR France
Countries in which this study is being conducted
International study

Denmark
France
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed27/11/2013
Start date of data collection03/11/201428/11/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report30/11/201615/12/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBoehringer Ingelheim GmbH100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Pladevall-Vila
First name Manel
Address line 1Trav. Gracia, 56, Atico 1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain
Phone number (incl. country code)34932417768 
Alternative phone number34932417766 
Fax number (incl. country code)34934142610 
Email address mpladevall@rti.org
Public Enquiries
Title Dr 
Last name Pladevall-Vila 
First name Manel 
Address line 1Trav. Gracia, 56, Atico 1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain 
Phone number (incl. country code)34932417768 
Alternative phone number34932417766 
Fax number (incl. country code)34934142610 
Email address mpladevall@rti.org 
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