Status: Planned First registered on: 28/05/2015
Last updated on: 13/10/2016
1. Study identification
EU PAS Register NumberEUPAS9827
Official titleDrug utilisation study (DUS) on the use of Cholib® (fenofibrate and simvastatin fixed combination): a European multinational study using secondary health records databases
Study title acronym
Study typeObservational study
Brief description of the studyStatins have been shown to reduce total cholesterol and LDL-C levels. They are commonly used and recommended in patients with dyslipidaemia (Catapano et al. 2011).3 Fibrates are also used to lower total cholesterol and triglycerides (TG) levels. They are prescribed to patients intolerant to statins alone, or as second line of treatment in combination with statins. Combination of simvastatin and fenofibrate leads to additional improvement of lipid parameters compared with simvastatin monotherapy in patients with mixed dyslipidaemia who required a treatment targeting a broader lipoprotein spectrum (Grundy et al. 2005).11 Cholib® is a fixed combination tablet, composed of fenofibrate (145 mg) and simvastatin (20mg or 40mg). It will be the first available registered drug combining both substances in one tablet. Cholib® is 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. Initiation of Cholib® treatment requires an adequate pre-treatement with simvastatin (at 20 or 40 mg) otherwise it is considered off-label use. This potential risk is part of the Risk Management Plan (RMP) and will be further investigated in this study conducted to estimate the proportion of patients who initiated Cholib® without prior simvastatin therapy.
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

France
Hungary
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed06/01/201506/01/2015
Start date of data collection01/06/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2017
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 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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