Non-interventional Cohort Study to Investigate Sertindole Prescription Management in Real-Life Practice

Study identification

• EU PAS number:
  EUPAS14033
• Study ID:
  22800
• Official title and acronym:
  Non-interventional Cohort Study to Investigate Sertindole Prescription Management in Real-Life Practice
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Greece

  Poland

  Slovakia
• Study description:
  The objective of the study is to check compliance of sertindole prescribers to perform ECG monitoring in real-life practice in line with sertindole SmPC requirement.
• Study status:
  Finalised

Research institutions and networks

Institutions

H. Lundbeck

TFS Lünd (Sweden)

Study timelines

Date when funding contract was signed

Planned: 18/07/2016

Actual: 18/07/2017

Study start date

Planned: 30/12/2016

Actual: 12/12/2016

Data analysis start date

Planned: 28/02/2017

Actual: 27/10/2017

Date of final study report

Planned: 29/12/2017

Actual: 19/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

H.Lundbeck A/S

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)