Loperamide and the risk of Brugada syndrome

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/32005
• EU PAS number:
  EUPAS32004
• Study ID:
  32005
• Official title and acronym:
  Loperamide and the risk of Brugada syndrome
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Calculate incidence of Brugada syndrome in patients treated with loperamide products.
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 15/01/2018

Actual: 15/01/2018

Study start date

Planned: 01/02/2018

Actual: 01/02/2018

Date of final study report

Planned: 05/03/2018

Actual: 05/03/2018

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable