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A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
Sponsor: AstraZeneca
Summary
This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).
Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
796
Start Date
2023-11-22
Completion Date
2025-10-10
Last Updated
2026-11-03
Healthy Volunteers
No
Interventions
Baxdrostat
Baxdrostat tablet administered orally, once daily (QD). Unit dose strengths: * 1 mg per tablet for 1 mg baxdrostat Arm; * 2 mg per tablet for 2 mg baxdrostat Arm.
Placebo
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Locations (263)
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Saraland, Alabama, United States
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Scottsdale, Arizona, United States
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Sun City West, Arizona, United States
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Surprise, Arizona, United States
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Little Rock, Arkansas, United States
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Fresno, California, United States
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Lincoln, California, United States
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Orange, California, United States
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Rancho Cucamonga, California, United States
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Stanford, California, United States
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New Haven, Connecticut, United States
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Clearwater, Florida, United States
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Jacksonville, Florida, United States
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Port Orange, Florida, United States
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Decatur, Georgia, United States
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East Point, Georgia, United States
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Springfield, Illinois, United States
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Munster, Indiana, United States
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Lexington, Kentucky, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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Olive Branch, Mississippi, United States
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Kansas City, 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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Rosedale, New York, United States
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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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New Bern, North Carolina, United States
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Toledo, Ohio, United States
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Grants Pass, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Memphis, Tennessee, United States
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Brownsville, Texas, United States
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Corpus Christi, Texas, United States
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Houston, Texas, United States
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Sugar Land, Texas, United States
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Manassas, Virginia, United States
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Suffolk, Virginia, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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CABA, Argentina
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CABA, Argentina
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Ciudad de Buenos Aires, Argentina
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Córdoba, Argentina
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Córdoba, Argentina
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Mar del Plata, Argentina
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Mendoza, Argentina
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Rosario, Argentina
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San Miguel de Tucumán, Argentina
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San Nicolás, Argentina
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San Vicente, Argentina
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Clayton, Australia
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Darlinghurst, Australia
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Epping, Australia
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Geelong, Australia
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Liverpool, Australia
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New Lambton Heights, Australia
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Perth, Australia
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Wollongong, Australia
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Woolloongabba, Australia
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Braunau am Inn, Austria
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Sankt Pölten, Austria
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Vienna, Austria
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Ghent, Belgium
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Liège, Belgium
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Mons, Belgium
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Pleven, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Edmonton, Alberta, Canada
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North Vancouver, British Columbia, Canada
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Cambridge, Ontario, Canada
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Markham, Ontario, Canada
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Newmarket, Ontario, Canada
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Ottawa, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Saint-Jean-sur-Richelieu, Quebec, Canada
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Benešov, Czechia
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Brandýs nad Labem, Czechia
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Broumov, Czechia
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Louny, Czechia
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Ostrava, Czechia
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Příbram, Czechia
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Uherské Hradiště, Czechia
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Aarhus, Denmark
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Herning, Denmark
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Holbæk, Denmark
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Bobigny, France
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Bordeaux, France
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Paris, France
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Paris, France
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Saint-Priest-en-Jarez, France