1. Study identification
EU PAS Register NumberEUPAS8044
Official titleEvaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of Trimetazidine in Bulgaria, Czech Republic, Estonia, France, Hungary, Latvia, Lithuania, Poland, Portugal, Romania, Slovakia, and Spain
Study title acronym
Study typeOther: Survey among healthcare professionals
Brief description of the studyEvaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of Trimetazidine in Bulgaria, Czech Republic, Estonia, France, Hungary, Latvia, Lithuania, Poland, Portugal, Romania, Slovakia, and Spain
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 belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
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
Bulgaria
Czech Republic
Estonia
France
Hungary
Latvia
Lithuania
Poland
Portugal
Romania
Slovakia
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed05/11/201405/11/2014
Start date of data collection20/11/201424/11/2014
Start date of data analysis02/01/2015
Date of interim report, if expected
Date of final study report31/03/201528/04/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesConsortium led by Lupin100
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)
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)
6. Study drug(s) information
Single-Constituent (Substance INN)TRIMETAZIDINE
7. Medical conditions to be studied
Medical condition(s)No
8. Population under study
Age
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects5000
Additional information
This is a multi-national, cross-sectional, non-interventional and anonymous web-based survey carried out among physicians. The survey will be conducted among prescribers, or potential prescribers, of TMZ in the selected countries.
Thus the number of patients is not relevant to this study, but it is required from each participant to submit up to 10 cases of trimetazidine prescriptions.
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
case report forms
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
Primary objective:
• to evaluate the proportion of targeted physicians who received, understood and agreed to implement the updated information about TMZ provided in the DHPC
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cross-sectional study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
All analysis will be descriptive in nature and no statistical comparison will be done in this study. Results will be presented overall, by country and per specialty.
Quantitative data will be summarized descriptively using n, mean, median, standard deviation, minimum and maximum. Categorical data will be summarized using frequency and percentage. 95% confidence interval (Wald’s) may be constructed around the percentage values for some variables. Some of the variables may also be summarized by country. All variables will be analyzed in total and separately for ophthalmologists, ENT specialists, cardiologists and others based on the information provided.
In a first step, calculations will be performed on raw data.
In a second step, the results will be weighted according to the real proportion of physicians in each country