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Heart Failure and Impaired Kidney FunctionHeart and circulationDrugPhase 3

What this study is

This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.

What's being tested

  • balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg

    Intervention · DRUG

    1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use

  • balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg

    Intervention · DRUG

    1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use

  • dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

    Intervention · DRUG

    1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use

Study details

Official title
A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function
Sponsor
AstraZeneca
Conditions
Heart Failure and Impaired Kidney Function
Enrolling
3,850 people
Starts
2024-04-12
Est. completion
2027-04-16
Design
Quadruple-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗