Study identification

EU PAS number

EUPAS16088

Study ID

32375

Official title and acronym

Post-authorization Safety Study Evaluation of Neoplasm Events in Users of Mirabegron and Other Treatments for Overactive Bladder : Core Common Protocol

DARWIN EU® study

No

Study countries

Denmark
Sweden
United Kingdom
United States

Study description

Mirabegron 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 malignant neoplasms 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).

Study status

Finalised
Research institutions and networks

Institutions

Optum
Germany
First published:
07/02/2014
Institution Outdated Other ENCePP partner
RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner
Comprehensive Health Insights Louisville, KY USA

Contact details

John Seeger

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Global Development, Inc.
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)