Status: Finalised First registered on: 31/05/2017
Last updated on: 21/06/2018
1. Study identification
EU PAS Register NumberEUPAS17681
Official titleAn Observational Drug Utilization Study of SYCREST® (asenapine) in the United Kingdom (P08308)
Study title acronym
Study typeObservational study
Brief description of the studyThis is a retrospective observational cohort study designed to describe asenapine prescribing patterns in the United Kingdom (UK) during the post-approval period in the general practice (GP) setting. The use of asenapine in Bipolar Disorder (BD) and other indications including Schizophrenia will be described. To provide epidemiological and clinical perspective, use of aripiprazole, olanzapine, quetiapine, and risperidone will also be described.
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 applicableNCT01498770 SCH 900274 P08308 MK-8274-108
2. Research centres and Investigator details
Coordinating study entity
Centre nameMerck Sharp & Dohme Corp.
Centre locationKenilworth, New Jersey, U.S.A.
Details of (Primary) lead investigator
Title Dr
Last name Merck Sharp & Dohme Corp.
First name Clinical Trials Disclosure
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 signed02/12/2010
Start date of data collection01/04/2013
Start date of data analysis18/12/201721/12/2017
Date of interim report, if expected13/09/2013
Date of final study report31/01/201825/01/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMerck Sharp & Dohme Corp100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Merck Sharp & Dohme Corp.
First name Clinical Trials Disclosure
Address line 12000 Galloping Hill Road
Address line 2 
Address line 3 
CityKenilworth, N.J. 
Postcode07033 
CountryUnited States
Phone number (incl. country code)1-7325941816 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Merck Sharp & Dohme Corp. 
First name Clinical Trials Disclosure 
Address line 12000 Galloping Hill Road 
Address line 2 
Address line 3 
CityKenilworth, N.J. 
Postcode07033 
CountryUnited States 
Phone number (incl. country code)1-7325941816 
Alternative phone number 
Fax number (incl. country code) 
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