Status: Ongoing First registered on: 06/05/2013
Last updated on: 13/04/2020
1. Study identification
EU PAS Register NumberEUPAS3911
Official titleXarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages
Study title acronym
Study typeObservational study
Brief description of the studyThis cross-sectional epidemiologic study will measure physician and patient awareness and understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert card.
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 Andrews
First name Elizabeth B.
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?50
Countries in which this study is being conducted
International study

France
Germany
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed16/12/2011
Start date of data collection15/09/201415/09/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report10/06/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Andrews
First name Elizabeth B.
Address line 1200 Park Offices Drive
Address line 2PO Box 12194 
Address line 3 
CityResearch Triangle Park 
PostcodeNC 27709 
CountryUnited States
Phone number (incl. country code)01-9195415819 
Alternative phone number 
Fax number (incl. country code) 
Email address eandrews@rti.org
Public Enquiries
Title Dr 
Last name Bayer AG 
First name Bayer Clinical Trials Contact 
Address line 1Müllerstraße 178 
Address line 2 
Address line 3 
CityBerlin 
Postcode13342 
CountryGermany 
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address clinical-trials-contact@bayer.com 
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