Status: Finalised First registered on: 22/01/2015
Last updated on: 11/07/2017
1. Study identification
EU PAS Register NumberEUPAS8408
Official titleAssessment of Utilisation of Pioglitazone in Denmark Post Label Change (July 2011)
Study title acronym
Study typeObservational study
Brief description of the studyOn the 11 of July 2011, EMA approved a label change for Pioglitazone that included new labelling on haematuria, bladder cancer and guidance on monitoring treatment effectiveness. A Dear Healthcare Provider Communication (DHPC) letter was sent to Danish prescribers on 11 August 2011 informing them of the label change. This drug utilisation study (DUS) aims to assess compliance with prescribing information in Denmark following the July 2011 labelling changes.
Was this study requested by a regulator?Yes: Denmark
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 belongsEvidera
Department/Research group
Organisation/affiliationEvidera
Website/Homepagewww.evidera.com
Details of (Primary) lead investigator
Title Dr
Last name Cid
First name Javier
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

Denmark
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed06/02/201506/02/2015
Start date of data collection01/07/201508/11/2015
Start date of data analysis01/03/201601/03/2016
Date of interim report, if expected
Date of final study report29/07/201627/06/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTakeda Europe100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Dolin
First name Paul
Address line 161 Aldwych
Address line 2Pharmacoepidemiology, Takeda Development Centre Europe 
Address line 3 
CityLondon 
PostcodeWC2B 4AE 
CountryUnited Kingdom
Phone number (incl. country code)442031168328 
Alternative phone number 
Fax number (incl. country code) 
Email address paul.dolin@takeda.com
Public Enquiries
Title Dr 
Last name Dolin 
First name Paul 
Address line 1One Takeda Parkway 
Address line 2 
Address line 3 
CityDeerfield 
Postcode60015 
CountryUnited States 
Phone number (incl. country code)12245546500 
Alternative phone number 
Fax number (incl. country code) 
Email address trialdisclosures@takeda.com 
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