An Observational Drug Utilization Study of SYCREST® (asenapine) in the United Kingdom (P08308)

Study identification

• EU PAS number:
  EUPAS17681
• Study ID:
  24560
• Official title and acronym:
  An Observational Drug Utilization Study of SYCREST® (asenapine) in the United Kingdom (P08308)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Study timelines

Date when funding contract was signed

Actual: 02/12/2010

Study start date

Actual: 01/04/2013

Data analysis start date

Planned: 18/12/2017

Actual: 21/12/2017

Date of interim report, if expected

Actual: 13/09/2013

Date of final study report

Planned: 31/01/2018

Actual: 25/01/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

NCT01498770SCH 900274 P08308MK-8274-108