Status: Finalised First registered on: 03/02/2017
Last updated on: 24/07/2019
1. Study identification
EU PAS Register NumberEUPAS17678
Official titleAgomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation Measures
Study title acronym
Study typeObservational study
Brief description of the studyNon-interventional, multinational Post-Autorisation Safety Study in patients initiating agomelatine treatment in routine clinical practice in Denmark, France, Germany, and Spain. The study includes a retrospective medical data abstraction to collect patient data before and after the last minimization measures in order to evaluate adherence to the liver test monitoring regimen and compliance with relevant contraindications and a cross-sectional patient survey to assess patients’ reasons for non-compliance with the liver test monitoring regimen. Medical data abstraction will collect characteristics of agomelatine users including relevant comorbidities, date, dose, and duration of agomelatine prescriptions and of fluvoxamine and/or ciprofloxacin; date of liver function tests (ALT and AST) and results. The patient survey will collect patients’ characteristics, knowledge of the key liver safety information, and reasons for non-compliance with liver test monitoring when applicable.
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/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management
Details of (Primary) lead investigator
Title Dr
Last name Hamm
First name Lynne
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?51
Countries in which this study is being conducted
International study

Denmark
France
Germany
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/05/2016
Start date of data collection31/01/201714/05/2017
Start date of data analysis
Date of interim report, if expected31/07/2017
Date of final study report31/03/201823/03/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesInstitut de Recherches Internationales 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 
Postcode92284 
CountryFrance
Phone number (incl. country code)33155727191 
Alternative phone number 
Fax number (incl. country code) 
Email address christele.percheron@servier.com
Public Enquiries
Title Ms 
Last name PERCHERON 
First name Christèle 
Address line 150 rue Carnot 
Address line 2 
Address line 3 
CitySuresnes 
Postcode92284 
CountryFrance 
Phone number (incl. country code)33155727191 
Alternative phone number 
Fax number (incl. country code) 
Email address christele.percheron@servier.com 
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