Status: Finalised First registered on: 02/03/2017
Last updated on: 02/03/2017
1. Study identification
EU PAS Register NumberEUPAS18049
Official titleDrug utilisation study, in five European countries, using cross sectional analysis, to assess the extent of prescriptions of trimetazidine for its withdrawn ophthalmological and ENT indications among general practitioners, ophthalmologists and ENT specialists
Study title acronym
Study typeObservational study
Brief description of the studyThe aim of the study was to verify the compliance of prescribers regarding the restricted indication of trimetazidine after marketing authorisation changes in 2012. The primary objective was to assess, per country, the proportion of prescriptions of trimetazidine for ophthalmological or ENT diagnoses (within the scope of its past indications) among the total prescriptions of trimetazidine after the restriction of its indications.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
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 belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Website/Homepagehttp://www.imshealth.com/portal/site/ims?CURRENT_LOCALE=en_go
Details of (Primary) lead investigator
Title Dr
Last name Massoud
First name Toussi
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

France
Greece
Poland
Romania
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed27/09/2012
Start date of data collection01/12/201201/12/2012
Start date of data analysis01/07/201401/07/2014
Date of interim report, if expected
Date of final study report30/09/201410/12/2015
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 Mrs
Last name PERRET
First name Sophie
Address line 150 rue Carnot
Address line 2 
Address line 3 
CitySuresnes 
Postcode92284 
CountryFrance
Phone number (incl. country code)33155724816 
Alternative phone number 
Fax number (incl. country code) 
Email address sophie.perret@servier.com
Public Enquiries
Title Mrs 
Last name PERRET 
First name Sophie 
Address line 150 rue Carnot 
Address line 2 
Address line 3 
CitySuresnes 
Postcode92284 
CountryFrance 
Phone number (incl. country code)33155724816 
Alternative phone number 
Fax number (incl. country code) 
Email address sophie.perret@servier.com 
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