An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
Phase of Trial: Phase III
Latest Information Update: 19 Nov 2019
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At a glance
- Drugs Dapagliflozin (Primary)
- Indications Heart failure
- Focus Registrational; Therapeutic Use
- Acronyms DELIVER
- Sponsors AstraZeneca
- 16 Sep 2019 According to an AstraZeneca media release, based on DAPA-HF and DELIVER trials, the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of FARXIGA (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).
- 04 Sep 2018 Planned End Date changed from 25 Jun 2021 to 22 Jun 2021.
- 04 Sep 2018 Planned primary completion date changed from 25 Jun 2021 to 22 Jun 2021.