A prospective observational registry study to characterise normal conditions of use, dosing and safety following administration of vernakalant IV sterile concentrate

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26663
• EU PAS number:
  EUPAS2078
• Study ID:
  26663
• Official title and acronym:
  A prospective observational registry study to characterise normal conditions of use, dosing and safety following administration of vernakalant IV sterile concentrate
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Denmark

  Finland

  Germany

  Spain

  Sweden
• Study description:
  This non-interventional prospective study is a post-authorization safety study of vernakalant conducted to collect information about normal conditions of use and appropriate dosing, and to quantify possible medically significant risk associated with the use of vernakalant in real-world clinical practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gyermek háziorvosi rendelő

Multiple centres: 45 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 05/01/2010

Actual: 05/01/2010

Study start date

Planned: 30/09/2011

Actual: 02/09/2011

Data analysis start date

Planned: 09/05/2018

Actual: 14/07/2018

Date of final study report

Planned: 30/07/2018

Actual: 29/10/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Correvio International

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)