Status: Finalised First registered on: 23/02/2017
Last updated on: 11/05/2017
1. Study identification
EU PAS Register NumberEUPAS17963
Official titleMonitoring of Compliance with Exenatide Prescribing Guidelines in Canada: Drug Utilisation Study of BYETTA in Canada for 2011-2014
Study title acronym
Study typeOther: Drug Utilisation Study
Brief description of the studyThis was a retrospective cohort study conducted to evaluate adherence to the labelling recommendations for BYETTA use in Canada. Data from the Canadian IMS Brogan’s Longitudinal Patient Data assets (LRx) for 2011-2014 was used.
Was this study requested by a regulator?Yes: Canada
Is the study required by a Risk Management Plan (RMP)? Non-EU RMP only
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableD5550N00008
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Website/Homepagehttp://www.imshealth.com/portal/site/ims?CURRENT_LOCALE=en_go
Details of (Primary) lead investigator
Title Dr
Last name Frise
First name Sarah
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

Canada
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/01/201120/01/2011
Start date of data collection01/06/201101/06/2011
Start date of data analysis01/07/201401/07/2014
Date of interim report, if expected
Date of final study report25/03/201525/03/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca Canada100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Frise
First name Sarah
Address line 11800 Concord Pike
Address line 2PO Box 15437 
Address line 3 
CityWilmington, De 
Postcode19850 
CountryUnited States
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code) 
Email address information.center@astrazeneca.com
Public Enquiries
Title Dr 
Last name AstraZeneca 
First name Clinical Study Information Center 
Address line 11800 Concord Pike 
Address line 2PO Box 15437 
Address line 3 
CityWilmington, De 
Postcode19850 
CountryUnited States 
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code) 
Email address information.center@astrazeneca.com 
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