Status: Finalised First registered on: 05/03/2013
Last updated on: 06/04/2018
1. Study identification
EU PAS Register NumberEUPAS3603
Official titleAn Observational Post-Authorization Modified Prescription-Event Monitoring Safety Study To Monitor The Safety And Utilization Of Asenapine (Sycrest) In The Primary Care Setting In England
Study title acronym
Study typeObservational study
Brief description of the studyAsenapine is a novel atypical antipsychotic agent, developed for the treatment of moderate to severe manic episodes associated with bipolar I disorder and schizophrenia in adults. This post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of asenapine (SYCREST®) aims to systematically collect and report drug utilisation and safety data on patients newly initiated on treatment with asenapine in the primary care setting in England. The study aims to collect exposure and outcome data for a cohort of approximately 5000 evaluable patients.
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 belongsDSRU
Department/Research group
Organisation/affiliationDrug Safety Research Unit
Website/Homepagewww.dsru.org
Details of (Primary) lead investigator
Title Professor
Last name Shakir
First name Saad
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 signed16/08/201116/08/2011
Start date of data collection01/01/201201/01/2012
Start date of data analysis01/01/201301/04/2013
Date of interim report, if expected
Date of final study report28/02/201812/01/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMerck Inc100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Lynn
First name Elizabeth
Address line 1DSRU
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom
Phone number (incl. country code)44-2380-408600 
Alternative phone number 
Fax number (incl. country code)44-2380-408609 
Email address elizabeth.lynn@dsru.org
Public Enquiries
Title Dr 
Last name Lynn 
First name Elizabeth 
Address line 1DSRU 
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom 
Phone number (incl. country code)44-2380-408600 
Alternative phone number 
Fax number (incl. country code)44-2380-408609 
Email address elizabeth.lynn@dsru.org 
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