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Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Sponsor: AstraZeneca
Summary
Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF. The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1. Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation. Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD. In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.
Official title: A Phase III, Randomised, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
11300
Start Date
2025-03-14
Completion Date
2029-12-17
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Baxdrostat and dapagliflozin
baxdrostat tablet and dapagliflozin tablet
Placebo and dapagliflozin
placebo tablet and dapagliflozin tablet
Locations (977)
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Birmingham, Alabama, United States
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Centreville, Alabama, United States
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Fairhope, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Sheffield, Alabama, United States
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Vestavia Hills, Alabama, United States
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Anchorage, Alaska, United States
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Gilbert, Arizona, United States
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Glendale, Arizona, United States
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Tempe, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Concord, California, United States
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Daly City, California, United States
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Dublin, California, United States
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Huntington Beach, California, United States
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Inglewood, California, United States
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La Jolla, California, United States
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Lakewood, California, United States
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Lincoln, California, United States
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Loma Linda, 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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Sacramento, California, United States
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San Diego, California, United States
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San Dimas, 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 Maria, California, United States
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Sherman Oaks, California, United States
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Thousand Oaks, California, United States
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Aurora, Colorado, United States
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Englewood, Colorado, United States
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Bridgeport, Connecticut, United States
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Stamford, Connecticut, United States
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Waterbury, Connecticut, United States
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Boca Raton, Florida, United States
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Crystal River, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Lakeland, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, 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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Ocoee, Florida, United States
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Orlando, Florida, United States
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Palmetto Bay, Florida, United States
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Riverview, Florida, United States
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Saint Augustine, Florida, United States
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Albany, Georgia, United States
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Atlanta, Georgia, United States
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Canton, Georgia, United States
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Columbus, Georgia, United States
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Cordele, Georgia, United States
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Suwanee, Georgia, United States
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Tucker, Georgia, United States
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Woodstock, Georgia, United States
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Idaho Falls, Idaho, United States
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Champaign, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Gurnee, Illinois, United States
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Island Lake, Illinois, United States
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Park Ridge, Illinois, United States
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Indianapolis, Indiana, United States
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Munster, Indiana, United States
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Richmond, Indiana, United States
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South Bend, Indiana, United States
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El Dorado, Kansas, United States
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Lenexa, Kansas, United States
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Newton, Kansas, United States
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Wichita, Kansas, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Owensboro, Kentucky, United States
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Paducah, Kentucky, United States
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Alexandria, Louisiana, United States
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Bossier City, Louisiana, United States
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Franklinton, Louisiana, United States
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Olla, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Beltsville, Maryland, United States
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Lutherville-Timonium, Maryland, United States
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Potomac, Maryland, United States
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Boston, Massachusetts, United States
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New Bedford, Massachusetts, United States
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Roslindale, Massachusetts, 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