An Observational Post-Authorization Safety Surveillance (PASS) Study of SYCREST® (asenapine) among Patients aged 18 and older Diagnosed with Bipolar Disorder (P08307)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/24619
• EU PAS number:
  EUPAS17631
• Study ID:
  24619
• Official title and acronym:
  An Observational Post-Authorization Safety Surveillance (PASS) Study of SYCREST® (asenapine) among Patients aged 18 and older Diagnosed with Bipolar Disorder (P08307)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This is a retrospective cohort study of new-users of asenapine in adult general practice patients in the United Kingdom (UK) from both the Clinical Practice Research Datalink (CPRD) and The Health Improvement Network (THIN) databases to assess incidence rates of identified and potential risks. Comparative analyses will be performed when adequate power is achieved.
• Study status:
  Finalised

Research institution and networks

Institutions

Merck & Co.

Study timelines

Date when funding contract was signed

Actual: 02/12/2010

Study start date

Actual: 01/07/2013

Data analysis start date

Planned: 18/12/2017

Actual: 18/12/2017

Date of interim report, if expected

Actual: 16/09/2014

Date of final study report

Planned: 31/01/2018

Actual: 24/01/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp.

Study protocol

Initial protocol

8274-110+Protocol_final-redaction

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

Merck protocol numbers: P08307, MK-8274-110ClinicalTrials.gov: NCT01495741