Status: Finalised First registered on: 29/07/2015
Last updated on: 07/05/2019
1. Study identification
EU PAS Register NumberEUPAS10446
Official titlePost-Authorisation Safety Study of Agomelatine and the Risk of Hospitalisation for Acute Liver Injury
Study title acronym
Study typeOther: Post-Authorization Safety Study (PASS)
Brief description of the studyThis is a large, multinational, longitudinal retrospective cohort and nested case-control study using 5 European databases aiming at comparing the risk of hospitalisation for acute liver injury (ALI) in patients initiating treatment with agomelatine and other antidepressants with the risk in patients initiating treatment with citalopram used as a common reference group.
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
Details of (Primary) lead investigator
Title Dr
Last name Pladevall
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?5

Southern Denmark University, Denmark
Countries in which this study is being conducted
International study

Denmark
Germany
Spain
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/04/2015
Start date of data collection29/01/201618/01/2016
Start date of data analysis
Date of interim report, if expected30/09/201629/09/2016
Date of final study report12/12/201712/12/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesLes Laboratoires Servier100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name PERCHERON
First name Christèle
Address line 150, rue Carnot
Address line 2 
Address line 3 
CitySuresnes cedex 
Postcode92284 
CountryFrance
Phone number (incl. country code)33155727191 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Ms 
Last name PERCHERON 
First name Christèle 
Address line 150, rue Carnot 
Address line 2 
Address line 3 
CitySuresnes cedex 
Postcode92284 
CountryFrance 
Phone number (incl. country code)33155727191 
Alternative phone number 
Fax number (incl. country code) 
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