Status: Finalised First registered on: 02/06/2015
Last updated on: 11/03/2019
1. Study identification
EU PAS Register NumberEUPAS9871
Official titleEvaluation of the Effectiveness of Risk Minimization Measures: Trimetazidine Drug Utilization Study in European Countries using databases – analysis for France, Hungary, Romania and Spain
Study title acronym
Study typeObservational study
Brief description of the studyTMZ-containing medicinal products were indicated in EU for various cardiology, ophthalmology and otolaryngology indications. Otolaryngology and ophthalmology indications included: i. Ancillary symptomatic treatment of vertigo and tinnitus and ii. Ancillary treatment of visual acuity decrease and visual field disturbances due to vascular reasons On 22 April 2011, France had requested the Committee for Medicinal Products for Human Use (CHMP) to give its opinion under Article 31 of Directive 2001/83/EC on whether the marketing authorization for TMZ-containing medicinal products will be maintained, varied, suspended or withdrawn. The review conducted by the CHMP concluded that the evidence of the efficacy and safety in the ophthalmology and otolaryngology indications, initially suggested by the studies on the basis of multiple assessments was considered weak due to the methodology applied to the investigation and was no longer recommended since September 2012 (3). Potential prescribers were informed of this change in the indication of TMZ through “Direct Healthcare Professional Communications” (DHPCs) and other appropriate notifications. The drug utilization study presented here is designed to evaluate the effectiveness of these risk minimization measures (RMM) on the use of TMZ in targeted countries based on information from prescription databases. In a parallel protocol, a survey will be conducted to provide information on the knowledge, attitude and behaviour of the physicians in the targeted countries about the content of the DHPC and the updated SMPC are evaluated.
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
Hungary
Romania
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed08/01/201508/01/2015
Start date of data collection01/06/201501/06/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report30/09/201516/09/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesConsoritum headed by Lupin Pharma100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Massoud
First name Toussi
Address line 15-7 place des Pyramides
Address line 2 
Address line 3 
CityParis La Défense 
Postcode92088 
CountryFrance
Phone number (incl. country code)33-1413-51335 
Alternative phone number 
Fax number (incl. country code) 
Email address mtoussi@fr.imshealth.com
Public Enquiries
Title Dr 
Last name Massoud 
First name Toussi 
Address line 15-7 place des Pyramides 
Address line 2 
Address line 3 
CityParis La Défense 
Postcode92088 
CountryFrance 
Phone number (incl. country code)33-1413-51335 
Alternative phone number 
Fax number (incl. country code) 
Email address mtoussi@fr.imshealth.com 
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