Status: FinalisedLast updated on: 09/09/2016
1. Study identification
EU PAS Register NumberEUPAS1591
Official titleCardiac profile of patients using rosiglitazone-containing anti-diabetes medicines: a study using the THIN database
Study title acronym
Study typeObservational study
Brief description of the studyThe study is a retrospective analysis of a cohort of patients prescribed rosiglitazone based on the UK GP database, THIN. It suggests that about 8% of patients take rosiglitazone despite having cardiac contraindications as defined by the current SPC – congestive heart failure or acute coronary syndrome.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameEuropean Medicines Agency
Centre locationLondon
Details of (Primary) lead investigator
Title Mr
Last name Slattery
First name Jim
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

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed13/08/2010
Start date of data collection13/08/2010
Start date of data analysis
Date of interim report, if expected
Date of final study report23/08/2010
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 bodyEuropean Medicines Agency100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Slattery
First name Jim
Address line 17 Westferry Circus
Address line 2 
Address line 3 
CityLondon 
PostcodeE14 4HB 
CountryUnited Kingdom
Phone number (incl. country code)44-207-5237166 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Mr 
Last name Slattery 
First name Jim 
Address line 17 Westferry Circus 
Address line 2 
Address line 3 
CityLondon 
PostcodeE14 4HB 
CountryUnited Kingdom 
Phone number (incl. country code)44-207-5237166 
Alternative phone number 
Fax number (incl. country code) 
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