Status: Finalised First registered on: 26/01/2011
Last updated on: 03/05/2021
1. Study identification
EU PAS Register NumberEUPAS1777
Official titleImpact of risk minimisation in patients treated with rosiglitazone-containing products
Study title acronym
Study typeObservational study
Brief description of the studyThis study will examine the effects of regulatory risk-minimisation measures on utilization of rosiglitazone containing products in the population; on incidence of acute drug reactions and on potential changes in objective diseases parameters in individual patients.
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?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

Aarhus University Dept. of Clinical Epidemiology
Boston Collaborative Drug Surveillance Program (GPRD access), Boston, USA
Countries in which this study is being conducted
International study

Denmark
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed14/12/2010
Start date of data collection01/02/201101/02/2011
Start date of data analysis01/02/201101/02/2011
Date of interim report, if expected01/04/201101/05/2011
Date of final study report01/10/201117/10/2011
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 1Olof Palmes Alle 43-45
Address line 2 
Address line 3 
CityAarhus N 
Postcode8200 
CountryDenmark
Phone number (incl. country code)45-89424800 
Alternative phone number49-17663169720 
Fax number (incl. country code) 
Email address ve@clin.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)45-89424800 
Alternative phone number 
Fax number (incl. country code)45-89424801 
Email address hts@clin.au.dk 
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