Post Marketing Surveillance on Long Term Drug Use of JARDIANCE® Tablets in Patients with chronic heart failure in Japan (PMS of JARDIANCE in CHF)

Study identification

• EU PAS number:
  EUPAS44340
• Study ID:
  46998
• Official title and acronym:
  Post Marketing Surveillance on Long Term Drug Use of JARDIANCE® Tablets in Patients with chronic heart failure in Japan (PMS of JARDIANCE in CHF)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic heart failure under real-world use.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned:17/03/2022

Actual:13/12/2021

Study start date

Planned:01/04/2022

Actual:01/04/2022

Data analysis start date

Planned:01/08/2024

Date of final study report

Planned:30/06/2025

Actual:18/03/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippon Boehringer Ingelheim Co., Ltd., Eli Lilly Japan K.K.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only