A regulatory requirement non-interventional study to monitor the safety and effectiveness of Jardiance® (empagliflozin, 10mg) in Korean patients with chronic heart failure (NYHA class II-IV)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47613
• EU PAS number:
  EUPAS44641
• Study ID:
  47613
• Official title and acronym:
  A regulatory requirement non-interventional study to monitor the safety and effectiveness of Jardiance® (empagliflozin, 10mg) in Korean patients with chronic heart failure (NYHA class II-IV)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  To monitor the safety profile and effectiveness of JARDIANCE® in Korean patients with chronic heart failure (NYHA class II-IV)
• Study status:
  Ongoing

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned: 30/06/2022

Actual: 20/06/2022

Study start date

Planned: 30/06/2022

Actual: 28/07/2022

Data analysis start date

Planned: 01/10/2025

Date of interim report, if expected

Planned: 22/01/2024

Actual: 19/01/2024

Date of final study report

Planned: 22/02/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Study protocol

Initial protocol

1245-0276-hfref-nis-protocol_v3.0_Redacted.pdf

Updated protocol

1245-0276-hfref-nis-protocol_v8.0_Redacted

Regulatory

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

Other study registration identification numbers and links

1245-0276