Status: Finalised First registered on: 26/08/2015
Last updated on: 19/08/2016
1. Study identification
EU PAS Register NumberEUPAS10786
Official titleStrattera patient exposures and adherence in the United Kingdom, Germany, the Netherlands, and Sweden: 2016 Bi-annual assessment report.
Study title acronymB4Z-MC-B025
Study typeOther: Drug utilisation study
Brief description of the studyThe objective of this study is to describe atomoxetine utilisation patterns for patients treated in the United Kingdom, Germany, the Netherlands, and Sweden from the time period of 2008 through 2014. This will be done by: -Estimating number of patients exposed, stratified by age -Estimating duration of exposure, medication possession ratio, and dose over the most recent 24 months -Estimating number of patients restarting, gap between, and duration of additional exposures over most recent 24 months, for those who stopped taking Strattera -Describing common comorbidity and concomitant medications
Was this study requested by a regulator?Yes: United Kingdom
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 Kristin
First name Meyers
Is this study being carried out with the collaboration of a research network?
Yes
IMS Health
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 signed26/08/201326/08/2013
Start date of data collection01/10/201501/10/2015
Start date of data analysis01/02/2016
Date of interim report, if expected
Date of final study report31/03/201621/03/2016
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 Kristin
First name Meyers
Address line 1Lilly Corporate Center
Address line 2Drop code 2638 
Address line 3MC/32/03 
CityIndianapolis 
Postcode46285 
CountryUnited States
Phone number (incl. country code)13172777831 
Alternative phone number 
Fax number (incl. country code) 
Email address meyers_kristin_joy@lilly.com
Public Enquiries
Title Dr 
Last name Kristin 
First name Meyers 
Address line 1Lilly Corporate Center 
Address line 2Drop code 2638 
Address line 3MC/32/03 
CityIndianapolis 
Postcode46285 
CountryUnited States 
Phone number (incl. country code)13172777831 
Alternative phone number 
Fax number (incl. country code) 
Email address meyers_kristin_joy@lilly.com 
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