Status: Planned First registered on: 07/10/2016
Last updated on: 18/03/2020
1. Study identification
EU PAS Register NumberEUPAS15741
Official titleAssessment of Health Care Professionals’ Knowledge and Behaviour Regarding Prescribing Conditions of Cholib® (fenofibrate and simvastatin fixed combination): A European PASS conducted in Austria, Portugal, Slovenia, Croatia, Greece and Bulgaria
Study title acronym
Study typeObservational study
Brief description of the studyCholib® is a fixed combination tablet, composed of fenofibrate (145 mg) and simvastatin (20 mg or 40 mg) and indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL-C levels when LDL-C levels are adequately controlled with the corresponding dose of simvastatin monotherapy. As a part of the Risk Management Plan (RMP), a drug utilization study (DUS) using available data was planned to estimate the proportion of Cholib® initiators without prior simvastatin monotherapy was not feasible due to inadequate number of patients treated. An alternative approach in the form of a prescriber survey questionnaire in countries where found feasible (Austria, Portugal, Slovenia, Croatia, and Bulgaria) was proposed as per discussion with EMA. The primary objective is to estimate the proportion of first Cholib® prescriptions without prior prescription of simvastatin of the corresponding daily dose (off-label use). The Secondary objectives are to estimate the proportion of first prescriptions of fenofibrate/simvastatin free combination (FSFC) without prior prescription of simvastatin monotherapy of the corresponding daily dose in patients with mixed dyslipidaemia; to describe and categorize the indications for the fenofibrate/simvastatin initiation, differentiating between Cholib® and FSFC to describe demographic and clinical characteristics of patients receiving these drugs. This multi-national, cross-sectional and anonymous web-based survey will be conducted in both public and private settings about physician´s practice and a maximum of 4 recent consecutive anonymous prescriptions of Cholib® and/or FSFC made during the preceding year. Results will be presented, overall and at country level per specialty.
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
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

Austria
Bulgaria
Croatia
Portugal
Slovenia
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed31/10/2016
Start date of data collection01/01/2017
Start date of data analysis01/03/2017
Date of interim report, if expected
Date of final study report30/06/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMylan100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Khan
First name Farhad Ali
Address line 1IMS Health AB
Address line 2Pyramidvägen 7 
Address line 3 
CitySolna 
Postcode169 56 
CountrySweden
Phone number (incl. country code)46850884246 
Alternative phone number 
Fax number (incl. country code) 
Email address fkhan@se.imshealth.com
Public Enquiries
Title Dr 
Last name Khan 
First name Farhad Ali 
Address line 1IMS Health AB 
Address line 2Pyramidvägen 7 
Address line 3 
CitySolna 
Postcode16956 
CountrySweden 
Phone number (incl. country code)46850884246 
Alternative phone number 
Fax number (incl. country code) 
Email address fkhan@se.imshealth.com 
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