Uncontrolled HypertensionPhase 3BaxHTNNCT06034743
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
A Phase 3 study testing Baxdrostat in people with Uncontrolled Hypertension and Resistant Hypertension, run by AstraZeneca at 263 sites in 29 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Uncontrolled Hypertension, Resistant Hypertension
- What is being tested?
- Baxdrostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 796 participants
- Where
- 263 sitesin 29 countries
- Study dates
- 22 Nov 2023to 10 Oct 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
263 sites in 29 countries.
263 sites in 29 countries
United States43 sites
Research Site
Atlanta, Georgia, 30344
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Bethlehem, Pennsylvania, 18017
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Brownsville, Texas, 78526
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Chapel Hill, North Carolina, 27599
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Clearwater, Florida, 33765
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Corpus Christi, Texas, 78404
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Decatur, Georgia, 30033
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Detroit, Michigan, 48202
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East Providence, Rhode Island, 02914
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Fresno, California, 93720
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Grants Pass, Oregon, 97527
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Houston, Texas, 77054
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Jacksonville, Florida, 32204
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Kansas City, Missouri, 64111
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Kansas City, Missouri, 64128
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Kansas City, Missouri, 64151
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Langhorne, Pennsylvania, 19047
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Lexington, Kentucky, 40503
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Lincoln, California, 95648
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Little Rock, Arkansas, 72211
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Madison, Wisconsin, 53792
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Manassas, Virginia, 20110
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Memphis, Tennessee, 38105
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Milwaukee, Wisconsin, 53295
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Munster, Indiana, 46321
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New Bern, North Carolina, 28562
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New Haven, Connecticut, 06510
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Olive Branch, Mississippi, 38654
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Orange, California, 92868
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Port Orange, Florida, 32127
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Rancho Cucamonga, California, 91730
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Rochester, Minnesota, 55905
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Rosedale, New York, 11422
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Saraland, Alabama, 36571
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Scottsdale, Arizona, 85054
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Springfield, Illinois, 62702
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Stanford, California, 94304
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Suffolk, Virginia, 23435
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Sugar Land, Texas, 77479
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Sun City West, Arizona, 85375
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Surprise, Arizona, 85374
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The Bronx, New York, 10455
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Toledo, Ohio, 43614
Germany18 sites
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Bad Homburg, 61348
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Bad Oeynhausen, 32545
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Berlin, 12203
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Berlin, 13347
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Dortmund, 44137
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Düsseldorf, 40225
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Elsterwerda, 04910
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Erlangen, 91054
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Essen, 45355
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Frankfurt, 60590
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Frankfurt, 60596
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Hanover, 30449
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Hanover, 30625
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Homburg, 66424
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Kaiserslautern, 67655
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Leipzig, 04103
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Mannheim, 68167
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Wermsdorf, 04779
Japan12 sites
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Adachi-ku, 121-0815
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Chūōku, 103-0027
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Chūōku, 260-0804
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Kanazawa, 920-8530
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Koga-shi, 306-0232
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Kyoto, 607-8062
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Nagasaki, 850-8555
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Okayama, 700-0804
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Osaka, 559-0012
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Sapporo, 003-0026
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Tsuchiura-shi, 300-0062
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Yufu-shi, 879-5593
South Korea12 sites
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Bucheon-si, 420-717
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Busan, 49241
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Daejeon, 35015
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Incheon, 21565
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Seoul, 02841
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Seoul, 03080
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Seoul, 03722
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Seoul, 04763
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Seoul, 05505
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Seoul, 07441
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Seoul, 07804
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Seoul, 08308
United Kingdom12 sites
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Bollington, SK10 5JH
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Bristol, BS34 6BQ
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Chesterfield, S40 4AA
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Dundee, DD1 9SY
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Glasgow, G51 4TF
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Harrow, HA3 7LT
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Hounslow, TW3 3LN
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London, EC1M 6BQ
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London, W6 7HY
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Prescot, L35 5DR
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Weston-super-Mare, BS24 7PR
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Yate, BS37 4AX
Argentina11 sites
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CABA, C1119ACN
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CABA, C1425HFA
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Ciudad de Buenos Aires, AR-CP 1221
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Córdoba, 5000
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Córdoba, X5003DCP
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Mar del Plata, B7600
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Mendoza, M5500
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Rosario, S2000PBJ
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San Miguel de Tucumán, 4000
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San Nicolás, B2900DMH
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San Vicente, 5006
Canada11 sites
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Cambridge, Ontario, N1R 6V6
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Chicoutimi, Quebec, G7H 7K9
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Edmonton, Alberta, T6G 2C8
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Markham, Ontario, L3S 0A2
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Newmarket, Ontario, L3Y 2P6
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North Vancouver, British Columbia, V7M 2H4
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Ottawa, Ontario, K1H 7W9
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Saint-Jean-sur-Richelieu, Quebec, J3A 1J2
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Scarborough Village, Ontario, M1B 4Z8
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Toronto, Ontario, M6G 1M2
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Waterloo, Ontario, N2T 0C1
India11 sites
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Delhi, 110029
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Delhi, 110060
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Guntur, 522001
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Kanpur, 208002
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Kolkata, 700014
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Kolkata, 700020
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Mysuru, 570004
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Mysuru, 570015
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New Delhi, 110002
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New Delhi, 110017
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Surat, 395001
Poland11 sites
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Bialystok, 15-540
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Bydgoszcz, 85-095
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Chrzanów, 32-500
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Gdansk, 80-214
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Gdynia, 81-338
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Krakow, 30-688
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Lodz, 91-002
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Poznan, 61-848
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Warsaw, 02-172
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Warsaw, 02-758
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Warsaw, 04-628
Italy10 sites
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Acquaviva delle Fonti, 70021
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Bologna, 40138
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Brescia, 25123
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Milan, 20122
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Milan, 20138
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Milan, 20149
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Pisa, 56126
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Roma, 00189
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Torino, 10126
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Udine, 33100
Australia9 sites
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Clayton, 3168
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Darlinghurst, 2010
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Epping, 3076
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Geelong, 3220
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Liverpool, 2170
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New Lambton Heights, 2305
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Perth, 6000
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Wollongong, 2500
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Woolloongabba, 4102
Spain9 sites
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Barcelona, 08003
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Barcelona, 08036
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Ferrol, 15405
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Granada, 18014
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Madrid, 28040
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Madrid, 28041
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Majadahonda, 28222
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Seville, 41004
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Terrassa (Barcelona), 08221
Taiwan9 sites
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Kaohsiung City, 80756
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Kaohsiung City, 81362
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Taichung, 40201
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Taichung, 40447
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Taichung, 433004
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Taipei, 10002
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Taipei, 110
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Taipei, 11217
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Yung Kang City, 71044
France8 sites
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Bobigny, 93000
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Bordeaux, 33076
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Paris, 75013
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Paris, 75015
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Saint-Priest-en-Jarez, 42270
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Toulon, 83100
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Toulouse, 31059
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Tours, 37044
Turkey (Türkiye)8 sites
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Adana, 01060
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Ankara, 06530
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Bursa, 16059
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Dinar, 03400
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Istanbul, 34862
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Izmir
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Kütahya, 43100
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Odunpazari, 26080
Czechia7 sites
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Benešov, 256 01
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Brandýs nad Labem, 250 01
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Broumov, 55001
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Louny, 440 01
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Ostrava, 708 52
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Příbram, 261 01
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Uherské Hradiště, 68601
Malaysia7 sites
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Kajang, 43000
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Kota Bharu, 15586
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Kuching, 93586
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Malacca, 75400
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Muar town, 84000
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Sarawak Miri, 98000
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Seri Manjung, 32040
South Africa7 sites
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Cape Town, 7500
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Centurion, 0157
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Claremont, 7708
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Durban, 4091
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Kwadwesi, 6201
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Somerset West, 7130
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Worcester, 6850
Thailand7 sites
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Bangkok, 10330
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Bangkok, 10400
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Bangkok, 10700
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Chiang Mai, 50200
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Hat Yai, 90110
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Khon Kaen, 40002
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Pathum Thani, 12120
Hungary6 sites
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Balatonfüred, 8230
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Budapest, 1115
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Kalocsa, 6300
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Kaposvár, 7400
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Nyíregyháza, 4400
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Pécs, 7623
Slovakia6 sites
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Brezno, 977 01
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Košice, 04022
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Moldava nad Bodvou, 04501
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Prešov, 080 01
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Rimavská Sobota, 979 01
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Svidník, 08901
Bulgaria5 sites
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Pleven, 5800
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Sofia, 1527
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Sofia, 1618
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Sofia, 1680
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Sofia, 1709
Israel5 sites
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Ashdod, 7747629
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Haifa, 3109601
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Petah Tikva, 49100
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Ramat Gan, 52621
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Rehovot, 76100
Vietnam5 sites
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Da Nang, 550000
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Hanoi, 100000
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Ho Chi Minh City, 700000
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Ho Chi Minh City, 70000
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Hochiminh City, 700000
Austria3 sites
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Braunau am Inn, 5280
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Sankt Pölten, 3100
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Vienna, 1090
Belgium3 sites
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Ghent, 9000
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Liège, 4000
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Mons, 7000
Denmark3 sites
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Aarhus, 8200
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Herning, 7400
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Holbæk, 4300
Netherlands3 sites
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Hoogeveen, 7909 AA
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Nijmegen, 6525 GA
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Utrecht, 3508 AB
About this study
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
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).
- Conditions
- Uncontrolled Hypertension, Resistant Hypertension
- Being tested
- Baxdrostat, Placebo
- Keywords
- Hypertension, Uncontrolled hypertension, Resistant hypertension, Blood pressure, Baxdrostat, CIN-107, Aldosterone, Aldosterone synthase
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaxdrostatDrug
Also called CIN-107
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.
PlaceboDrug
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
| Study group | Role | What they receive |
|---|---|---|
| 2 mg baxdrostat | Experimental | 2 mg baxdrostat administered orally, once daily (QD). Receives: Drug: Baxdrostat |
| 1 mg baxdrostat | Experimental | 1 mg baxdrostat administered orally, once daily (QD). Receives: Drug: Baxdrostat |
| Placebo | Placebo comparator | Placebo administered orally, once daily (QD). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. All available measurements were included, and missing data were multiply imputed.
Measured: 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. All available measurements were included, and missing data were multiply imputed.
Measured: At Week 12
Secondary outcomes (7)
Change From Randomised Withdrawal Baseline (Week 24) in Seated Systolic Blood Pressure (SBP) for 2 mg Baxdrostat
To assess the effect of 2 mg baxdrostat vs placebo on seated systolic blood pressure (SBP) at 8 weeks after randomised withdrawal (RWD). All available measurements were included, and missing data were multiply imputed.
Measured: At Week 32
Change From Baseline in Seated SBP for 2 mg Baxdrostat in the Resistant Hypertension Subpopulation
To assess the effect of 2 mg baxdrostat vs placebo on seated SBP at Week 12 in the resistant hypertension (rHTN) subpopulation. All available measurements were included, and missing data were multiply imputed.
Measured: At Week 12
Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 2 mg Baxdrostat
To assess the effect of 2 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12. All available measurements were included, and missing data were multiply imputed.
Measured: At Week 12
Number of Participants Who Achieved Seated SBP < 130 mmHg for 2 mg Baxdrostat
To assess the effect of 2 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12. All available measurements were included, and missing data were multiply imputed.
Measured: At Week 12
Change From Baseline in Seated SBP for 1 mg Baxdrostat in the Resistant Hypertension Subpopulation
To assess the effect of 1 mg baxdrostat vs placebo on seated SBP at Week 12 in the resistant hypertension (rHTN) subpopulation. All available measurements were included, and missing data were multiply imputed.
Measured: At Week 12
Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 1 mg Baxdrostat
To assess the effect of 1 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12. All available measurements were included, and missing data were multiply imputed.
Measured: At Week 12
Number of Participants Who Achieved Seated SBP < 130 mmHg for 1 mg Baxdrostat
To assess the effect of 1 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12. All available measurements were included, and missing data were multiply imputed.
Measured: At Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start22 Nov 2023
- Primary completion21 May 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 796 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034743
- Sponsor's protocol ID
- D6970C00002
- Other IDs
- 2023-505499-32-00, 2023
- Acronym
- BaxHTN
- Status last verified
- Jul 2026
- First submitted
- 6 Sep 2023
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40888730Flack JM, Azizi M, Brown JM, Dwyer JP, Jones ESW, Lihn AS, Liu L, Olsson DS, Perl S, Shibata H, Wang JG, Wilderang U, Wittes JT, Williams B. Baxdrostat for uncontrolled and resistant hypertension: rationale and design of the Phase 3 clinical trials BaxHTN, BaxAsia, and Bax24. Hypertens Res. 2025 Nov;48(11):2911-2923. doi: 10.1038/s41440-025-02297-7. Epub 2025 Aug 25.
PubMed 40850955Schiffrin EL. New Kids on the Hypertension Block: Novel Agents With New Mechanisms of Action. Am J Hypertens. 2024 Aug 14;37(9):651-653. doi: 10.1093/ajh/hpae051. No abstract available.
PubMed 39138914