Status: Finalised First registered on: 03/04/2014
Last updated on: 10/08/2017
1. Study identification
EU PAS Register NumberEUPAS6305
Official titleStrattera patient exposures and adherence in the United Kingdom, Germany, the Netherlands, and Sweden: 2014 Bi-annual assessment report
Study title acronym
Study typeObservational study
Brief description of the studyThe objective of this study is to describe atomoxetine (Strattera) utilization patterns for patients treated in Germany, United Kingdom (UK), Sweden, and the Netherlands
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 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 Nicole
First name Kellier
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
International study

Germany
Netherlands
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed16/08/201316/08/2013
Start date of data collection01/01/201401/01/2014
Start date of data analysis01/01/201401/01/2014
Date of interim report, if expected
Date of final study report28/03/201409/04/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEli Lilly and Company100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Nicole
First name Kellier
Address line 1Lilly Corporate Center
Address line 2 
Address line 3 
CityIndianapolis 
Postcode46285 
CountryUnited States
Phone number (incl. country code)13172763631 
Alternative phone number 
Fax number (incl. country code) 
Email address nkellier@lilly.com
Public Enquiries
Title Dr 
Last name Nicole 
First name Kellier 
Address line 1Lilly Corporate Center 
Address line 2 
Address line 3 
CityIndianapolis 
Postcode46285 
CountryUnited States 
Phone number (incl. country code)13172763631 
Alternative phone number 
Fax number (incl. country code) 
Email address nkellier@lilly.com 
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