Status: Finalised First registered on: 04/03/2013
Last updated on: 25/07/2018
1. Study identification
EU PAS Register NumberEUPAS3596
Official titleCilostazol Drug Utilisation Study
Study title acronym
Study typeObservational study
Brief description of the studyDrug utilisation study (DUS) on the use of cilostazol in several European populations The DUS is a cohort study of new users of cilostazol. Five European population-based automated health databases are participating: Spain (IACS and SIDIAP), Germany (GePaRD--pending approvals), the United Kingdom (THIN), and Sweden (Swedish National Databases). The DUS is being conducted in two phases: DUS1 and DUS2. DUS1 has been completed and evaluated cilostazol as used in clinical practice in the target countries during the period from cilostazol launch through 2011. DUS2 will now be conducted after the implementation of changes to the summary of product characteristics (SmPC) and the follow-up communication activities with health care professionals (HCPs) and will evaluate the impact of these measures during the year 2014.
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 belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagewww.rtihs.org
Details of (Primary) lead investigator
Title Dr
Last name Castellsague
First name Jordi
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?4

IDIAPJGol
Centre for Pharmacoepidemiology (CPE)
BIPS GmbH
EpiChron
Countries in which this study is being conducted
International study

Germany
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/01/2013
Start date of data collection08/03/2013
Start date of data analysis09/04/2013
Date of interim report, if expected31/03/2015
Date of final study report18/05/201701/02/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesOtsuka Pharmaceutical Europe, Ltd.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Castellsague
First name Jordi
Address line 1Trav. Gracia, 56, Atico 1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain
Phone number (incl. country code)34932417766 
Alternative phone number34932417763 
Fax number (incl. country code)34934142610 
Email address castellsague@rti.org
Public Enquiries
Title Dr 
Last name Perez-Gutthann 
First name Susana 
Address line 1Trav. Gracia, 56, Atico 1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain 
Phone number (incl. country code)34932417766 
Alternative phone number34932417760 
Fax number (incl. country code)34934142610 
Email address sperez@rti.org 
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