Status: Finalised First registered on: 26/01/2015
Last updated on: 10/04/2019
1. Study identification
EU PAS Register NumberEUPAS8444
Official titlePost-authorization Safety Program Using the Swedish National Registers—A Validation Study of Cardiovascular and Neoplasm Events in Users of Pharmacological 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 is a retrospective cohort study of new users of individual antimuscarinic drugs: oxybutynin, tolterodine, darifenacin, solifenacin, and fesoterodine. The objectives are: to describe drug-use patterns, to describe the availability of potential confounders in the Swedish data resources, and to calculate background rates of cardiovascular (CV) and cancer outcomes among antimuscarinic drug users in the Swedish Prescription and Inpatient National Databases, in collaboration with the Karolinska Institutet (KI) Center for Pharmacoepidemiology (CPE). Results will help to refine the study size and statistical power assessment for the post-marketing safety studies of Mirabegron, to be conducted, among other data sources, in the Swedish Databases. The study period is July 1, 2005 through December 2012. The study will calculate incidence rates of the following endpoints : - CV: including acute myocardial infarction, stroke, all-cause mortality, a MACE composite endpoint, and CV mortality. - Neoplasm endpoint: The study will focus on a composite of the 10 most commonly occurring malignancies. For cancer analyses only the first incident targeted cancer is considered.
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 belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagewww.rtihs.org
Details of (Primary) lead investigator
Title Dr
Last name Arana
First name Alejandro
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?2

Centre for Pharmacoepidemiology (CPE)
RTI-HS
Countries in which this study is being conducted
National study

Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/09/201410/10/2014
Start date of data collection05/01/201505/01/2015
Start date of data analysis
Date of interim report, if expected06/02/201526/03/2015
Date of final study report29/02/201616/02/2016
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 Arana
First name Alejandro
Address line 1Trav. Gracia, 56, Atico 1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain
Phone number (incl. country code)34933622805 
Alternative phone number 
Fax number (incl. country code)34934142610 
Email address aarana@rti.org
Public Enquiries
Title Dr 
Last name Arana 
First name Alejandro 
Address line 1Trav. Gracia, 56, Atico 1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain 
Phone number (incl. country code)34933622805 
Alternative phone number 
Fax number (incl. country code)34934142610 
Email address aarana@rti.org 
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