Status: Ongoing First registered on: 20/05/2015
Last updated on: 20/05/2015
1. Study identification
EU PAS Register NumberEUPAS9771
Official titleThe Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation (NVAF) Patient Population-A Retrospective Database Analysis
Study title acronym
Study typeObservational study
Brief description of the studyThis study is of a retrospective cohort design with propensity score matching. The primary study objective is to assess the safety and effectiveness of dabigatran compared to warfarin in patients diagnosed with non-valvular atrial fibrillation in the DoD population.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
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 belongsEvidera
Department/Research group
Organisation/affiliationEvidera
Website/Homepagewww.evidera.com
Details of (Primary) lead investigator
Title Mr
Last name Evidera
First name Evidera
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 States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed27/09/201327/09/2013
Start date of data collection22/01/201422/01/2014
Start date of data analysis04/07/201423/05/2014
Date of interim report, if expected
Date of final study report15/06/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBoehringer Ingelheim Pharmaceuticals, Inc.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Evidera
First name Evidera
Address line 1430 Bedford St., Suite 300
Address line 2 
Address line 3 
CityLexington 
Postcode02420 
CountryUnited States
Phone number (incl. country code)14108274780 
Alternative phone number 
Fax number (incl. country code) 
Email address matthew.reynolds@evidera.com
Public Enquiries
Title Mr 
Last name Evidera 
First name Evidera 
Address line 1430 Bedford St., Suite 300 
Address line 2 
Address line 3 
CityLexington 
Postcode02420 
CountryUnited States 
Phone number (incl. country code)14108274780 
Alternative phone number 
Fax number (incl. country code) 
Email address matthew.reynolds@evidera.com 
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