Status: Ongoing First registered on: 25/04/2017
Last updated on: 05/05/2020
1. Study identification
EU PAS Register NumberEUPAS18735
Official titleDrug Utilisation Study of Intuniv® (guanfacine extended release) in European Countries, Study protocol I: Database study
Study title acronymIntuniv data base study Europe
Study typeObservational study
Brief description of the studyThis is a multi-country drug utilization study using retrospective database analysis. A single database for all target countries is not available. Therefore an approach was chosen which includes multiple data sources to gather drug utilization data for Intuniv in European target countries. In case longitudinal patient level data do not exist in a target country, a prescriber survey will be conducted, which is described in a separate protocol.
Was this study requested by a regulator?No
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 groupIQVIA Real World Insights
Organisation/affiliationIMS Health
Website/Homepagehttp://quintilesims.com
Details of (Primary) lead investigator
Title Dr
Last name von Bredow
First name Dorothea
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

Denmark
Germany
Norway
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/08/201630/08/2016
Start date of data collection01/02/201915/11/2018
Start date of data analysis
Date of interim report, if expected30/06/201911/06/2019
Date of final study report30/06/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTakeda Pharmaceutical Company Limited100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Page
First name Matthew
Address line 1Takeda Pharmaceutical Company Limited
Address line 2650 E. Kendall Street 
Address line 3 
CityCambridge 
PostcodeMA 02142 
CountryUnited States
Phone number (incl. country code)1-617-5843570 
Alternative phone number 
Fax number (incl. country code) 
Email address matt.page@takeda.com
Public Enquiries
Title Dr 
Last name Page 
First name Matthew 
Address line 1Takeda Pharmaceutical Company Limited 
Address line 2650 E. Kendall Street 
Address line 3 
CityCambridge 
PostcodeMA 02142 
CountryUnited States 
Phone number (incl. country code)1-617-5843570 
Alternative phone number 
Fax number (incl. country code) 
Email address matt.page@takeda.com 
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