Status: Finalised First registered on: 21/07/2015
Last updated on: 11/03/2019
1. Study identification
EU PAS Register NumberEUPAS10001
Official titleA PHARMO Study on the Utilization of Pioglitazone in Clinical Practice in The Netherlands with Regard to Diabetic Treatment Regimen and Co-morbidities
Study title acronym
Study typeObservational study
Brief description of the studyThe goal of this study is to describe the prescription of pioglitazone in diabetic patients according to Summary of Product Characteristics (SmPC), and to evaluate the implementation of the risk minimization measures introduced in July 2011 regarding bladder cancer and heart failure and the need for regular review of the benefits of therapy. This drug utilization study will describe the pioglitazone users with regard to age, sex, concomitant drug use, and prevalent comorbidities at the time of their first pioglitazone prescription, specifically hypertension and ischemic heart disease.
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
Not applicable (single centre)

Countries in which this study is being conducted
National study

Netherlands
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed23/07/2012
Start date of data collection01/08/2012
Start date of data analysis01/09/2012
Date of interim report, if expected
Date of final study report17/10/2012
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTDC Europe100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Dolin
First name Paul
Address line 161 Aldwych
Address line 2 
Address line 3 
CityLondon 
PostcodeWC2B 4AE 
CountryUnited Kingdom
Phone number (incl. country code)442031168328 
Alternative phone number 
Fax number (incl. country code) 
Email address trialdisclosures@takeda.com
Public Enquiries
Title Mr 
Last name Dolin 
First name Paul 
Address line 161 Aldwych 
Address line 2 
Address line 3 
CityLondon 
PostcodeWC2B 4AE 
CountryUnited Kingdom 
Phone number (incl. country code)442031168328 
Alternative phone number 
Fax number (incl. country code) 
Email address trialdisclosures@takeda.com 
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