Post-Marketing Surveillance on the Use of Prazaxa® (Japanese Prazaxa PMS, second)

Study identification

• EU PAS number:
  EUPAS19283
• Study ID:
  43885
• Official title and acronym:
  Post-Marketing Surveillance on the Use of Prazaxa® (Japanese Prazaxa PMS, second)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Multiple centres: 800 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:01/03/2017

Actual:09/03/2017

Study start date

Planned:01/07/2017

Actual:26/07/2017

Data analysis start date

Planned:14/04/2021

Actual:14/04/2021

Date of final study report

Planned:31/10/2021

Actual:28/10/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippon Boehringer Ingelheim Co., Ltd.,

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only