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Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
Sponsor: AstraZeneca
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
3850
Start Date
2024-04-12
Completion Date
2027-04-16
Last Updated
2026-10-13
Healthy Volunteers
No
Interventions
balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
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
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
1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use
Locations (852)
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Alexander City, Alabama, United States
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Birmingham, Alabama, United States
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Fairhope, Alabama, United States
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Huntsville, Alabama, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Covina, California, United States
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Encinitas, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Orange, California, United States
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Redding, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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San Francisco, California, United States
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Santa Ana, California, United States
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Thousand Oaks, California, United States
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Vista, California, United States
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West Hills, California, United States
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Aurora, Colorado, United States
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Wheat Ridge, Colorado, United States
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Altamonte Springs, Florida, United States
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Boca Raton, Florida, United States
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Bradenton, Florida, United States
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Clearwater, Florida, United States
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Delray Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Palm Beach Gardens, Florida, United States
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Pensacola, Florida, United States
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Port Charlotte, Florida, United States
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Safety Harbor, Florida, United States
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Saint Augustine, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Peachtree City, Georgia, United States
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Thomasville, Georgia, United States
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Tucker, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Glenview, Illinois, United States
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Hazel Crest, Illinois, United States
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North Chicago, Illinois, United States
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Peoria, Illinois, United States
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Winfield, Illinois, United States
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Elkhart, Indiana, United States
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Evansville, Indiana, United States
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Hammond, Indiana, United States
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Indianapolis, Indiana, United States
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Muncie, Indiana, United States
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Munster, Indiana, United States
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Richmond, Indiana, United States
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Waterloo, Iowa, United States
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Wichita, Kansas, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Alexandria, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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West Monroe, Louisiana, United States
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Augusta, Maine, United States
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Rockville, Maryland, United States
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Boston, Massachusetts, United States
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Fall River, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Bloomfield Hills, Michigan, United States
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Dearborn, Michigan, United States
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Farmington Hills, Michigan, United States
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Flint, Michigan, United States
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Troy, Michigan, United States
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Ypsilanti, Michigan, United States
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Minneapolis, Minnesota, United States
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Saint Paul, Minnesota, United States
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Jackson, Mississippi, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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Kansas City, Missouri, United States
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Lincoln, Nebraska, United States
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Lincoln, Nebraska, United States
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Henderson, Nevada, United States
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North Las Vegas, Nevada, United States
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Bridgewater, New Jersey, United States
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Jersey City, New Jersey, United States
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Somerset, New Jersey, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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Brooklyn, New York, United States
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Clifton Park, New York, United States
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Manhasset, New York, United States
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New Windsor, New York, United States