Status: Planned First registered on: 07/04/2017
Last updated on: 07/04/2017
1. Study identification
EU PAS Register NumberEUPAS18536
Official titleCharacterising the safety profile of lurasidone in clinical practice: A drug utilisatio and safety study using a United Kingdom primary care database
Study title acronymNone
Study typeObservational study
Brief description of the studyThe study will describe drug utilization patters and characterize the safety profile of lurasidone compared to other second generation antipsychotics in a real world UK primary healthcare setting
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 belongsOXON
Department/Research group
Organisation/affiliationOxon Epidemiology Ltd.
Website/Homepagewww.oxonepi.com
Details of (Primary) lead investigator
Title Dr
Last name Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.)
First name Nawab
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 Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed14/01/2014
Start date of data collection01/06/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report01/12/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesSunovion Pharmaceuticals Europe Ltd100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Clarke
First name Quentin
Address line 1Sunovion Pharmaceuticals Europe Ltd
Address line 2Southside 
Address line 397-105 Victoria Street 
CityLondon 
PostcodeSW1E6QT 
CountryUnited Kingdom
Phone number (incl. country code)44-0207-8212840 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Mr 
Last name Clarke 
First name Quentin 
Address line 1Sunovion Pharmaceuticals Europe Ltd 
Address line 2Southside 
Address line 397-105 Victoria Street 
CityLondon 
PostcodeSW1E6QT 
CountryUnited Kingdom 
Phone number (incl. country code)44-0207-8212840 
Alternative phone number 
Fax number (incl. country code) 
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