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
BaxHTN
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
2 other identifiers
interventional
796
28 countries
260
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2023
260 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedStudy Start
First participant enrolled
November 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2025
CompletedNovember 10, 2025
November 1, 2025
1.5 years
September 6, 2023
November 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline in seated systolic blood pressure for 2 mg baxdrostat
To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12
At Week 12
Change from baseline in seated systolic blood pressure for 1 mg baxdrostat
To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12
At Week 12
Secondary Outcomes (7)
Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat
At Week 32
Change from baseline in seated SBP for 2 mg baxdrostat
At Week 12
Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat
At Week 12
Achieving seated SBP < 130 mmHg for 2 mg baxdrostat
At Week 12
Change from baseline in seated SBP for 1 mg baxdrostat
At Week 12
- +2 more secondary outcomes
Other Outcomes (1)
Number of participants with adverse events (AEs)
Up to Week 54
Study Arms (3)
2 mg baxdrostat
EXPERIMENTAL2 mg baxdrostat administered orally, once daily (QD).
1 mg baxdrostat
EXPERIMENTAL1 mg baxdrostat administered orally, once daily (QD).
Placebo
PLACEBO COMPARATORPlacebo administered orally, once daily (QD).
Interventions
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.
Eligibility Criteria
You may qualify if:
- Male or female participants must be ≥ 18 years old
- Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and \< 170 mmHg at Screening
- Fulfil at least 1 of the following 2 criteria:
- uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator
- rHTN subpopulation: have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator
- Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening
- Serum potassium (K+) level ≥ 3.5 and \< 5.0 mmol/L at Screening
- Randomisation Criterion:
- Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at the Baseline Visit
You may not qualify if:
- Mean sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmHg
- Mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmHg
- Serum sodium level \< 135 mmol/L at Screening
- Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation
- New York Heart Association functional heart failure class IV at Screening
- Persistent atrial fibrillation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (263)
Research Site
Saraland, Alabama, 36571, United States
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Scottsdale, Arizona, 85054, United States
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Sun City West, Arizona, 85375, United States
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Surprise, Arizona, 85374, United States
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Little Rock, Arkansas, 72211, United States
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Fresno, California, 93720, United States
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Lincoln, California, 95648, United States
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Orange, California, 92868, United States
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Rancho Cucamonga, California, 91730, United States
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Stanford, California, 94304, United States
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New Haven, Connecticut, 06510, United States
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Clearwater, Florida, 33765, United States
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Jacksonville, Florida, 32204, United States
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Port Orange, Florida, 32127, United States
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Atlanta, Georgia, 30344, United States
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Decatur, Georgia, 30033, United States
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Springfield, Illinois, 62702, United States
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Munster, Indiana, 46321, United States
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Lexington, Kentucky, 40503, United States
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Detroit, Michigan, 48202, United States
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Rochester, Minnesota, 55905, United States
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Olive Branch, Mississippi, 38654, United States
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Kansas City, Missouri, 64111, United States
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Kansas City, Missouri, 64128, United States
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Kansas City, Missouri, 64151, United States
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Rosedale, New York, 11422, United States
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The Bronx, New York, 10455, United States
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Chapel Hill, North Carolina, 27599, United States
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New Bern, North Carolina, 28562, United States
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Toledo, Ohio, 43614, United States
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Grants Pass, Oregon, 97527, United States
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Bethlehem, Pennsylvania, 18017, United States
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Langhorne, Pennsylvania, 19047, United States
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East Providence, Rhode Island, 02914, United States
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Memphis, Tennessee, 38105, United States
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Brownsville, Texas, 78526, United States
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Corpus Christi, Texas, 78404, United States
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Houston, Texas, 77054, United States
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Sugar Land, Texas, 77479, United States
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Manassas, Virginia, 20110, United States
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Suffolk, Virginia, 23435, United States
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Madison, Wisconsin, 53792, United States
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Milwaukee, Wisconsin, 53295, United States
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CABA, C1119ACN, Argentina
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CABA, C1425AGC, Argentina
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Ciudad de Buenos Aires, AR-CP 1221, Argentina
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Córdoba, 5000, Argentina
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Córdoba, X5003DCP, Argentina
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Mar del Plata, B7600, Argentina
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Mendoza, M5500, Argentina
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Rosario, S2000PBJ, Argentina
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San Miguel de Tucumán, 4000, Argentina
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San Nicolás, B2900DMH, Argentina
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San Vicente, 5006, Argentina
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Clayton, 3168, Australia
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Darlinghurst, 2010, Australia
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Epping, 3076, Australia
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Geelong, 3220, Australia
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Liverpool, 2170, Australia
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New Lambton Heights, 2305, Australia
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Perth, 6000, Australia
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Wollongong, 2500, Australia
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Woolloongabba, 4102, Australia
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Braunau am Inn, 5280, Austria
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Sankt Pölten, 3100, Austria
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Vienna, 1090, Austria
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Ghent, 9000, Belgium
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Liège, 4000, Belgium
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Mons, 7000, Belgium
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Pleven, 5800, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1618, Bulgaria
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Sofia, 1680, Bulgaria
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Sofia, 1709, Bulgaria
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Edmonton, Alberta, T6G 2C8, Canada
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North Vancouver, British Columbia, V7M 2H4, Canada
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Cambridge, Ontario, N1R 6V6, Canada
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Markham, Ontario, L3S 0A2, Canada
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Newmarket, Ontario, L3Y 2P6, Canada
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Ottawa, Ontario, K1H 7W9, Canada
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Scarborough Village, Ontario, M1B 4Z8, Canada
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Toronto, Ontario, M6G 1M2, Canada
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Waterloo, Ontario, N2T 0C1, Canada
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Chicoutimi, Quebec, G7H 7K9, Canada
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Saint-Jean-sur-Richelieu, Quebec, J3A 1J2, Canada
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Benešov, 256 01, Czechia
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Brandýs nad Labem, 250 01, Czechia
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Broumov, 55001, Czechia
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Louny, 440 01, Czechia
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Ostrava, 708 52, Czechia
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Příbram, 261 01, Czechia
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Uherské Hradiště, 68601, Czechia
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Aarhus, 8200, Denmark
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Herning, 7400, Denmark
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Holbæk, 4300, Denmark
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Bobigny, 93000, France
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Bordeaux, 33076, France
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Paris, 75013, France
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Paris, 75015, France
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Saint-Priest-en-Jarez, 42270, France
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Toulon, 83100, France
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Toulouse, 31059, France
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Tours, 37044, France
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Bad Homburg, 61348, Germany
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Bad Oeynhausen, 32545, Germany
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Berlin, 12203, Germany
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Berlin, 13347, Germany
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Dortmund, 44137, Germany
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Düsseldorf, 40225, Germany
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Elsterwerda, 04910, Germany
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Erlangen, 91054, Germany
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Essen, 45355, Germany
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Frankfurt, 60590, Germany
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Frankfurt, 60596, Germany
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Hanover, 30449, Germany
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Hanover, 30625, Germany
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Homburg, 66424, Germany
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Kaiserslautern, 67655, Germany
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Leipzig, 04103, Germany
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Mannheim, 68167, Germany
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Wermsdorf, 04779, Germany
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Balatonfüred, 8230, Hungary
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Budapest, 1115, Hungary
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Kalocsa, 6300, Hungary
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Kaposvár, 7400, Hungary
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Nyíregyháza, 4400, Hungary
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Pécs, 7623, Hungary
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Delhi, 110029, India
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Delhi, 110060, India
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Guntur, 522001, India
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Kanpur, 208002, India
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Kolkata, 700014, India
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Kolkata, 700020, India
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Mysuru, 570004, India
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Mysuru, 570015, India
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New Delhi, 110002, India
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New Delhi, 110017, India
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Surat, 395001, India
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Ashdod, 7747629, Israel
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Haifa, 3109601, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Rehovot, 76100, Israel
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Acquaviva delle Fonti, 70021, Italy
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Bologna, 40138, Italy
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Brescia, 25123, Italy
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Milan, 20122, Italy
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Milan, 20138, Italy
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Milan, 20149, Italy
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Pisa, 56126, Italy
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Roma, 00189, Italy
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Torino, 10126, Italy
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Udine, 33100, Italy
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Adachi-ku, 121-0815, Japan
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Chūōku, 103-0027, Japan
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Chūōku, 260-0804, Japan
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Kanazawa, 920-8530, Japan
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Koga-shi, 306-0232, Japan
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Kyoto, 607-8062, Japan
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Nagasaki, 850-8555, Japan
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Okayama, 700-0804, Japan
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Osaka, 559-0012, Japan
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Sapporo, 003-0026, Japan
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Tsuchiura-shi, 300-0062, Japan
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Yufu-shi, 879-5593, Japan
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Kajang, 43000, Malaysia
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Kota Bharu, 15586, Malaysia
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Kuching, 93586, Malaysia
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Malacca, 75400, Malaysia
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Muar town, 84000, Malaysia
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Sarawak Miri, 98000, Malaysia
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Seri Manjung, 32040, Malaysia
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Hoogeveen, 7909 AA, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Utrecht, 3508 AB, Netherlands
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Bialystok, 15-540, Poland
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Bydgoszcz, 85-095, Poland
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Chrzanów, 32-500, Poland
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Gdansk, 80-214, Poland
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Gdynia, 81-338, Poland
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Krakow, 30-688, Poland
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Lodz, 91-002, Poland
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Poznan, 61-848, Poland
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Warsaw, 02-172, Poland
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Warsaw, 02-758, Poland
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Warsaw, 04-628, Poland
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Brezno, 977 01, Slovakia
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Košice, 04022, Slovakia
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Moldava nad Bodvou, 04501, Slovakia
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Prešov, 080 01, Slovakia
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Rimavská Sobota, 979 01, Slovakia
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Svidník, 08901, Slovakia
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Cape Town, 7500, South Africa
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Centurion, 0157, South Africa
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Claremont, 7708, South Africa
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Durban, 4001, South Africa
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Kwadwesi, 6201, South Africa
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Somerset West, 7130, South Africa
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Worcester, 6850, South Africa
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Bucheon-si, 420-717, South Korea
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Busan, 49241, South Korea
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Daejeon, 35015, South Korea
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Incheon, 21565, South Korea
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Seoul, 02841, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 04763, South Korea
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Seoul, 05505, South Korea
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Seoul, 07441, South Korea
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Seoul, 07804, South Korea
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Seoul, 08308, South Korea
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Barcelona, 08003, Spain
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Barcelona, 08036, Spain
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Ferrol, 15405, Spain
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Granada, 18014, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Majadahonda, 28222, Spain
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Seville, 41004, Spain
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Terrassa (Barcelona), 08221, Spain
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Gothenburg, 413 45, Sweden
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Uppsala, 75185, Sweden
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 81362, Taiwan
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Taichung, 40201, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 433004, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 110, Taiwan
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Taipei, 11217, Taiwan
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Yung Kang City, 71044, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Pathum Thani, 12120, Thailand
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Adana, 01060, Turkey (Türkiye)
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Ankara, 06530, Turkey (Türkiye)
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Bursa, 16059, Turkey (Türkiye)
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Dinar, 03400, Turkey (Türkiye)
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Istanbul, 34862, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Kütahya, 43100, Turkey (Türkiye)
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Odunpazari, 26080, Turkey (Türkiye)
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Bollington, SK10 5JH, United Kingdom
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Bristol, BS34 6BQ, United Kingdom
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Chesterfield, S40 4AA, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Glasgow, G51 4TF, United Kingdom
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Harrow, HA3 7LT, United Kingdom
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Hownslow, TW3 3LN, United Kingdom
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London, EC1M 6BQ, United Kingdom
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London, W6 7HY, United Kingdom
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Prescot, L35 5DR, United Kingdom
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Weston-super-Mare, BS24 7PR, United Kingdom
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Yate, BS37 4AX, United Kingdom
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Da Nang, 550000, Vietnam
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
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Hochiminh City, 700000, Vietnam
Related Publications (1)
Flack JM, Azizi M, Brown JM, Dwyer JP, Fronczek J, Jones ESW, Olsson DS, Perl S, Shibata H, Wang JG, Wilderang U, Wittes J, Williams B; BaxHTN Investigators. Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension. N Engl J Med. 2025 Oct 9;393(14):1363-1374. doi: 10.1056/NEJMoa2507109. Epub 2025 Aug 30.
PMID: 40888730DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2023
First Posted
September 13, 2023
Study Start
November 22, 2023
Primary Completion
May 21, 2025
Study Completion
October 10, 2025
Last Updated
November 10, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.