Status: Finalised First registered on: 06/09/2016
Last updated on: 02/05/2019
1. Study identification
EU PAS Register NumberEUPAS15063
Official titleDrug utilization study of mirabegron (Betmiga®) using real-world healthcare databases from the Netherlands, Spain, United Kingdom and Finland
Study title acronymMirabegron DUS
Study typeObservational study
Brief description of the studyThe mirabegron (Betmiga®) Summary of Product Characteristics (SmPC) states that the drug is contraindicated in patients with “Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg”. In accordance and compliance with the European Medicines Agencies (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) request, a Direct Healthcare Professional Communication (DHPC) letter was disseminated on 7 September 2015 as a risk minimization activity in 30 countries in EU. In line with the EMA CHMP guideline Module IX, an effectiveness check of this risk minimization activity was proposed by Astellas. A drug utilization study (DUS) on the use of mirabegron in the Netherlands, Spain, United Kingdom and Finland will be performed as a risk minimization effectiveness check measure. The objectives of the study are to assess the effectiveness of the Direct Healthcare Professional Communication (DHPC) letter as a risk minimization measure in the participating countries by quantifying the proportions of mirabegron initiators with documented severe uncontrolled hypertension (primary objective) and the frequency of blood pressure recordings at baseline and during mirabegron treatment, especially in hypertensive patients (secondary objective) before and after DHPC dissemination.
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 belongsPHARMO Institute
Department/Research group
Organisation/affiliationThe PHARMO Institute for Drug Outcomes Research
Website/Homepagewww.pharmo.nl
Details of (Primary) lead investigator
Title Dr
Last name Herings
First name Ron
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4

Countries in which this study is being conducted
International study

Finland
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed26/07/2016
Start date of data collection21/02/2017
Start date of data analysis17/03/2017
Date of interim report, if expected
Date of final study report11/07/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstellas100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Bezemer
First name Irene
Address line 1Van Deventerlaan 30-40
Address line 2 
Address line 3 
CityUtrecht 
Postcode 
CountryNetherlands
Phone number (incl. country code)0031307440800 
Alternative phone number 
Fax number (incl. country code) 
Email address pharmo@pharmo.nl
Public Enquiries
Title Dr 
Last name Herings 
First name Ron 
Address line 1Van Deventerlaan 30-40 
Address line 2 
Address line 3 
CityUtrecht 
Postcode3528 AE 
CountryNetherlands 
Phone number (incl. country code)31307440800 
Alternative phone number 
Fax number (incl. country code) 
Email address pharmo@pharmo.nl 
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