Study identifier:D1699C00001
ClinicalTrials.gov identifier:NCT03036124
EudraCT identifier:2016-003897-41
CTIS identifier:N/A
Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients with Chronic Heart Failure with Reduced Ejection Fraction
Chronic Heart Failure with Reduced Ejection Fraction (HFrEF)
Phase 3
No
Dapagliflozin, Placebo
All
4744
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Aug 2020 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Dapagliflozin Patients will be randomized 1:1 to either dapagliflozin or placebo. | Drug: Dapagliflozin 10 mg or 5 mg tablets given once daily, per oral use. Other Name: Forxiga TM Other Name: Farxiga TM |
Placebo Comparator: Placebo Placebo matching dapagliflozin. | Drug: Placebo Placebo matching dapagliflozin 10 mg or 5 mg. |