Status: Finalised First registered on: 30/11/2016
Last updated on: 28/04/2020
1. Study identification
EU PAS Register NumberEUPAS16282
Official titlePost-authorization Safety Study Evaluation of Cardiovascular Events in Users of Mirabegron and Other Treatments for Overactive Bladder
Study title acronym
Study typeObservational study
Brief description of the studyMirabegron is a first in class therapeutic agent, with a mechanism of action distinct from that of antimuscarinic agents indicated for the treatment of overactive bladder (OAB). This post authorization safety study (PASS, or post marketing requirement (PMR) in the US) is designed to generate additional evidence to help evaluate the results observed in the clinical trials. To implement the program, we selected data sources from 5 research centers. The investigators are from RTI Health Solutions, Optum, University of Southern Denmark, Centre for Pharmacoepidemiology at Karolinska Institute, and Comprehensive Health Insights. The study population will include patients observed in each of the 5 databases, providing a wide array of patient characteristics, drug utilization and medical practice patterns, which will enhance the generalizability of the study findings to the population of mirabegron users in real world practice, beyond clinical trials. This will be a cohort study comparing the incidence of commonly occurring cardiovascular events among new users of mirabegron and new users of any comparator antimuscarinic medication (as a group) used in the treatment of OAB. To provide a sufficiently large patient population within which to evaluate the safety of mirabegron, the study will be conducted within multiple databases. Each of these populations will be studied according to the same Core protocol, although operational details will vary across sites due to the specifics of the data environments. In addition to data source-specific analyses, estimates obtained from all data sources will be analyzed using a meta-analysis approach. Overall, the study period includes October 2012 (first observed use of mirabegron in US data) through June 2019 (submission of final study report).
Was this study requested by a regulator?Yes: EMA, United States
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 belongsOptum
Department/Research group
Organisation/affiliationOptum
Website/Homepagehttp://www.optum.com
Details of (Primary) lead investigator
Title Dr
Last name Seeger
First name John
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

Centre for Pharmacoepidemiology (CPE)
RTI-HS
University of Southern Denmark, Odense C. Denmark
Comprehensive Health Insights, Louisville, KY USA
Countries in which this study is being conducted
International study

Denmark
Sweden
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed10/08/201522/09/2015
Start date of data collection09/01/201706/09/2016
Start date of data analysis20/02/2017
Date of interim report, if expected29/06/2018
Date of final study report28/06/201915/11/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstellas Pharma Global Development, Inc.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Seeger
First name John
Address line 11325 Boylston St.
Address line 210th Floor 
Address line 3 
CityBoston 
Postcode02215 
CountryUnited States
Phone number (incl. country code)16175302275 
Alternative phone number 
Fax number (incl. country code)16175302803 
Email address john.seeger@optum.com
Public Enquiries
Title Dr 
Last name Seeger 
First name John 
Address line 11325 Boylston St. 
Address line 210th Floor 
Address line 3 
CityBoston 
Postcode02215 
CountryUnited States 
Phone number (incl. country code)16175302275 
Alternative phone number 
Fax number (incl. country code)16175302803 
Email address john.seeger@optum.com 
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