Study identification

PURI

https://redirect.ema.europa.eu/resource/29595

EU PAS number

EUPAS15063

Study ID

29595

Official title and acronym

Drug utilization study of mirabegron (Betmiga®) using real-world healthcare databases from the Netherlands, Spain, United Kingdom and Finland (Mirabegron DUS)

DARWIN EU® study

No

Study countries

Finland
Netherlands
Spain
United Kingdom

Study description

The 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.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Ron Herings

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Astellas
Study protocol
Initial protocol

178-pv-002-clp-en-final-v1-02

English (1.34 MB - PDF)View document
Updated protocol

PHARMO-Study Protocol-Mirabegron DUS_v1.2

English (1.39 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)