Status: Finalised First registered on: 12/07/2012
Last updated on: 15/12/2016
1. Study identification
EU PAS Register NumberEUPAS2765
Official titleMonitoring the effectiveness of risk minimisation in patients treated with pioglitazone-containing products
Study title acronym
Study typeObservational study
Brief description of the studyThe study has the following objectives 1: To provide observational data on drug utilisation patterns of pioglitazone-containing products in the European Union (EU) and to study associations between changes in drug utilisation patterns and the regulatory decisions in the form of DHPC. 2a: To analyse events in patients discontinuing pioglitazone after the DHPC, including adverse drug events, alterations in glycaemic control, and modification of other objective parameters of disease. 2b: To analyse contraindications and events in patients continuing or starting pioglitazone, including adverse drug events, alterations in glycaemic control, and modification of other objective parameters of disease. 3. To evaluate effectiveness of risk minimisation measures recommended by CHMP based on results obtained for Objective 1 and Objective 2. 4. To provide practical recommendations for improving effectiveness of risk minimisation measures. The objectives of the study will be achieved using data from automated pharmacoepidemiologic databases in three EU Member states: Denmark, The Netherlands, and United Kingdom.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 belongsAarhus University Dept. of Clinical Epidemiology
Department/Research groupDepartment of Clinical Epidemiology
Organisation/affiliationAarhus University / Aarhus University Hospital
Website/Homepagewww.kea.au.dk
Details of (Primary) lead investigator
Title Professor
Last name Sørensen
First name Henrik Toft
Is this study being carried out with the collaboration of a research network?
Yes
EU-ADR
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3

Aarhus University Dept. of Clinical Epidemiology
Erasmus MC Pharmacoepi
Boston Collaborative Drug Surveillance Program, Boston, USA
Countries in which this study is being conducted
International study

Denmark
Netherlands
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/01/201220/01/2012
Start date of data collection06/08/201214/08/2012
Start date of data analysis03/09/201203/09/2012
Date of interim report, if expected20/11/201229/11/2012
Date of final study report20/02/201329/11/2012
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherEMA100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Ehrenstein
First name Vera
Address line 1Dept of Clinical Epidemiology
Address line 2Olof Palmes Alle 43-45 
Address line 3 
CityAarhus 
Postcode8200 
CountryDenmark
Phone number (incl. country code)45-87168063 
Alternative phone number 
Fax number (incl. country code) 
Email address ve@dce.au.dk
Public Enquiries
Title Professor 
Last name Sørensen 
First name Henrik Toft 
Address line 1Olof Palmes Allé 43-45 
Address line 2 
Address line 3 
CityAarhus N 
Postcode8200 
CountryDenmark 
Phone number (incl. country code)45-87168063 
Alternative phone number 
Fax number (incl. country code)45-87167215 
Email address hts@dce.au.dk 
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