Uno studio per indagare l'efficacia e la sicurezza di Baxdrostat nei partecipanti con ipertensione non controllata su due o più farmaci, compresi i partecipanti con ipertensione resistente (BaxHTN)
9 ottobre 2026 aggiornato da: AstraZeneca
Uno studio di gruppo parallelo randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza di Baxdrostat nei partecipanti con ipertensione incontrollata su due o più farmaci, compresi i partecipanti con ipertensione resistente
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).
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
796
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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CABA, Argentina, C1119ACN
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CABA, Argentina, C1425HFA
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Ciudad de Buenos Aires, Argentina, AR-CP 1221
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Córdoba, Argentina, 5000
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Córdoba, Argentina, X5003DCP
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Mar del Plata, Argentina, B7600
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Mendoza, Argentina, M5500
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Rosario, Argentina, S2000PBJ
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San Miguel de Tucumán, Argentina, 4000
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San Nicolás, Argentina, B2900DMH
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San Vicente, Argentina, 5006
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Clayton, Australia, 3168
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Darlinghurst, Australia, 2010
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Epping, Australia, 3076
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Geelong, Australia, 3220
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Liverpool, Australia, 2170
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New Lambton Heights, Australia, 2305
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Perth, Australia, 6000
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Wollongong, Australia, 2500
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Woolloongabba, Australia, 4102
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Braunau am Inn, Austria, 5280
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Sankt Pölten, Austria, 3100
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Vienna, Austria, 1090
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Ghent, Belgio, 9000
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Liège, Belgio, 4000
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Mons, Belgio, 7000
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Pleven, Bulgaria, 5800
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Sofia, Bulgaria, 1527
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Sofia, Bulgaria, 1618
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Sofia, Bulgaria, 1680
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Sofia, Bulgaria, 1709
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Alberta
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Edmonton, Alberta, Canada, T6G 2C8
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British Columbia
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North Vancouver, British Columbia, Canada, V7M 2H4
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Ontario
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Cambridge, Ontario, Canada, N1R 6V6
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Markham, Ontario, Canada, L3S 0A2
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Newmarket, Ontario, Canada, L3Y 2P6
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Ottawa, Ontario, Canada, K1H 7W9
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Scarborough Village, Ontario, Canada, M1B 4Z8
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Toronto, Ontario, Canada, M6G 1M2
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Waterloo, Ontario, Canada, N2T 0C1
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Quebec
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Chicoutimi, Quebec, Canada, G7H 7K9
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Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1J2
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Benešov, Cechia, 256 01
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Brandýs nad Labem, Cechia, 250 01
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Broumov, Cechia, 55001
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Louny, Cechia, 440 01
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Ostrava, Cechia, 708 52
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Příbram, Cechia, 261 01
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Uherské Hradiště, Cechia, 68601
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Bucheon-si, Corea del Sud, 420-717
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Busan, Corea del Sud, 49241
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Daejeon, Corea del Sud, 35015
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Incheon, Corea del Sud, 21565
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Seoul, Corea del Sud, 02841
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Seoul, Corea del Sud, 03080
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Seoul, Corea del Sud, 03722
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Seoul, Corea del Sud, 04763
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Seoul, Corea del Sud, 05505
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Seoul, Corea del Sud, 07441
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Seoul, Corea del Sud, 07804
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Seoul, Corea del Sud, 08308
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Aarhus, Danimarca, 8200
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Herning, Danimarca, 7400
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Holbæk, Danimarca, 4300
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Bobigny, Francia, 93000
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Bordeaux, Francia, 33076
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Paris, Francia, 75015
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Paris, Francia, 75013
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Saint-Priest-en-Jarez, Francia, 42270
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Toulon, Francia, 83100
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Toulouse, Francia, 31059
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Tours, Francia, 37044
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Bad Homburg, Germania, 61348
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Bad Oeynhausen, Germania, 32545
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Berlin, Germania, 12203
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Berlin, Germania, 13347
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Dortmund, Germania, 44137
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Düsseldorf, Germania, 40225
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Elsterwerda, Germania, 04910
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Erlangen, Germania, 91054
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Essen, Germania, 45355
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Frankfurt, Germania, 60596
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Frankfurt, Germania, 60590
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Hanover, Germania, 30449
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Hanover, Germania, 30625
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Homburg, Germania, 66424
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Kaiserslautern, Germania, 67655
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Leipzig, Germania, 04103
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Mannheim, Germania, 68167
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Wermsdorf, Germania, 04779
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Adachi-ku, Giappone, 121-0815
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Chūōku, Giappone, 103-0027
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Chūōku, Giappone, 260-0804
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Kanazawa, Giappone, 920-8530
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Koga-shi, Giappone, 306-0232
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Kyoto, Giappone, 607-8062
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Nagasaki, Giappone, 850-8555
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Okayama, Giappone, 700-0804
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Osaka, Giappone, 559-0012
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Sapporo, Giappone, 003-0026
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Tsuchiura-shi, Giappone, 300-0062
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Yufu-shi, Giappone, 879-5593
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Delhi, India, 110029
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Delhi, India, 110060
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Guntur, India, 522001
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Kanpur, India, 208002
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Kolkata, India, 700020
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Kolkata, India, 700014
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Mysuru, India, 570004
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Mysuru, India, 570015
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New Delhi, India, 110017
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New Delhi, India, 110002
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Surat, India, 395001
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Ashdod, Israele, 7747629
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Haifa, Israele, 3109601
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Petah Tikva, Israele, 49100
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Ramat Gan, Israele, 52621
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Rehovot, Israele, 76100
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Acquaviva delle Fonti, Italia, 70021
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Bologna, Italia, 40138
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Brescia, Italia, 25123
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Milan, Italia, 20138
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Milan, Italia, 20122
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Milan, Italia, 20149
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Pisa, Italia, 56126
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Roma, Italia, 00189
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Torino, Italia, 10126
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Udine, Italia, 33100
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Kajang, Malaysia, 43000
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Kota Bharu, Malaysia, 15586
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Kuching, Malaysia, 93586
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Malacca, Malaysia, 75400
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Muar town, Malaysia, 84000
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Sarawak Miri, Malaysia, 98000
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Seri Manjung, Malaysia, 32040
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Hoogeveen, Olanda, 7909 AA
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Nijmegen, Olanda, 6525 GA
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Utrecht, Olanda, 3508 AB
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Bialystok, Polonia, 15-540
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Bydgoszcz, Polonia, 85-095
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Chrzanów, Polonia, 32-500
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Gdansk, Polonia, 80-214
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Gdynia, Polonia, 81-338
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Krakow, Polonia, 30-688
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Lodz, Polonia, 91-002
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Poznan, Polonia, 61-848
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Warsaw, Polonia, 02-172
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Warsaw, Polonia, 02-758
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Warsaw, Polonia, 04-628
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Bollington, Regno Unito, SK10 5JH
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Bristol, Regno Unito, BS34 6BQ
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Chesterfield, Regno Unito, S40 4AA
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Dundee, Regno Unito, DD1 9SY
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Glasgow, Regno Unito, G51 4TF
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Harrow, Regno Unito, HA3 7LT
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Hounslow, Regno Unito, TW3 3LN
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London, Regno Unito, EC1M 6BQ
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London, Regno Unito, W6 7HY
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Prescot, Regno Unito, L35 5DR
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Weston-super-Mare, Regno Unito, BS24 7PR
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Yate, Regno Unito, BS37 4AX
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Brezno, Slovacchia, 977 01
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Košice, Slovacchia, 04022
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Moldava nad Bodvou, Slovacchia, 04501
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Prešov, Slovacchia, 080 01
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Rimavská Sobota, Slovacchia, 979 01
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Svidník, Slovacchia, 08901
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Barcelona, Spagna, 08036
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Barcelona, Spagna, 08003
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Ferrol, Spagna, 15405
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Granada, Spagna, 18014
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Madrid, Spagna, 28041
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Madrid, Spagna, 28040
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Majadahonda, Spagna, 28222
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Seville, Spagna, 41004
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Terrassa (Barcelona), Spagna, 08221
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Alabama
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Saraland, Alabama, Stati Uniti, 36571
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Arizona
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Scottsdale, Arizona, Stati Uniti, 85054
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Sun City West, Arizona, Stati Uniti, 85375
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Surprise, Arizona, Stati Uniti, 85374
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72211
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California
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Fresno, California, Stati Uniti, 93720
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Lincoln, California, Stati Uniti, 95648
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Orange, California, Stati Uniti, 92868
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Rancho Cucamonga, California, Stati Uniti, 91730
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Stanford, California, Stati Uniti, 94304
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06510
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Florida
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Clearwater, Florida, Stati Uniti, 33765
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Jacksonville, Florida, Stati Uniti, 32204
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Port Orange, Florida, Stati Uniti, 32127
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Georgia
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Decatur, Georgia, Stati Uniti, 30033
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East Point, Georgia, Stati Uniti, 30344
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Illinois
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Springfield, Illinois, Stati Uniti, 62702
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Indiana
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Munster, Indiana, Stati Uniti, 46321
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40503
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Michigan
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Detroit, Michigan, Stati Uniti, 48202
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
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Mississippi
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Olive Branch, Mississippi, Stati Uniti, 38654
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Missouri
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Kansas City, Missouri, Stati Uniti, 64111
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Kansas City, Missouri, Stati Uniti, 64128
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Kansas City, Missouri, Stati Uniti, 64151
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New York
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Rosedale, New York, Stati Uniti, 11422
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The Bronx, New York, Stati Uniti, 10455
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27599
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New Bern, North Carolina, Stati Uniti, 28562
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Ohio
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Toledo, Ohio, Stati Uniti, 43614
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Oregon
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Grants Pass, Oregon, Stati Uniti, 97527
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Pennsylvania
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Bethlehem, Pennsylvania, Stati Uniti, 18017
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Langhorne, Pennsylvania, Stati Uniti, 19047
- Research Site
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Rhode Island
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East Providence, Rhode Island, Stati Uniti, 02914
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Tennessee
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Memphis, Tennessee, Stati Uniti, 38105
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Texas
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Brownsville, Texas, Stati Uniti, 78526
- Research Site
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Corpus Christi, Texas, Stati Uniti, 78404
- Research Site
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Houston, Texas, Stati Uniti, 77054
- Research Site
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Sugar Land, Texas, Stati Uniti, 77479
- Research Site
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Virginia
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Manassas, Virginia, Stati Uniti, 20110
- Research Site
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Suffolk, Virginia, Stati Uniti, 23435
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Wisconsin
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Madison, Wisconsin, Stati Uniti, 53792
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Milwaukee, Wisconsin, Stati Uniti, 53295
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Cape Town, Sud Africa, 7500
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Centurion, Sud Africa, 0157
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Claremont, Sud Africa, 7708
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Durban, Sud Africa, 4091
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Kwadwesi, Sud Africa, 6201
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Somerset West, Sud Africa, 7130
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Worcester, Sud Africa, 6850
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Gothenburg, Svezia, 413 45
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Uppsala, Svezia, 75185
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Bangkok, Tailandia, 10330
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Bangkok, Tailandia, 10400
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Bangkok, Tailandia, 10700
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Chiang Mai, Tailandia, 50200
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Hat Yai, Tailandia, 90110
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Khon Kaen, Tailandia, 40002
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Pathum Thani, Tailandia, 12120
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Kaohsiung City, Taiwan, 80756
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Kaohsiung City, Taiwan, 81362
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Taichung, Taiwan, 40447
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Taichung, Taiwan, 40201
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Taichung, Taiwan, 433004
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Taipei, Taiwan, 10002
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Taipei, Taiwan, 11217
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Taipei, Taiwan, 110
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Yung Kang City, Taiwan, 71044
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Adana, Turchia (Türkiye), 01060
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Ankara, Turchia (Türkiye), 06530
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Bursa, Turchia (Türkiye), 16059
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Dinar, Turchia (Türkiye), 03400
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Istanbul, Turchia (Türkiye), 34862
- Research Site
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Izmir, Turchia (Türkiye)
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Kütahya, Turchia (Türkiye), 43100
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Odunpazari, Turchia (Türkiye), 26080
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Balatonfüred, Ungheria, 8230
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Budapest, Ungheria, 1115
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Kalocsa, Ungheria, 6300
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Kaposvár, Ungheria, 7400
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Nyíregyháza, Ungheria, 4400
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Pécs, Ungheria, 7623
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Da Nang, Vietnam, 550000
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Hanoi, Vietnam, 100000
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Ho Chi Minh City, Vietnam, 700000
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Ho Chi Minh City, Vietnam, 70000
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Hochiminh City, Vietnam, 700000
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 130 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
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Male or female participants must be ≥ 18 years old
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Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and < 170 mmHg at Screening
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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
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Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening
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Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening
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Randomisation Criterion:
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Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at the Baseline Visit
Exclusion Criteria:
- 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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 2 mg baxdrostat
2 mg baxdrostat administered orally, once daily (QD). |
Baxdrostat tablet administered orally, once daily (QD). Unit dose strengths:
Altri nomi:
|
|
Sperimentale: 1 mg baxdrostat
1 mg baxdrostat administered orally, once daily (QD). |
Baxdrostat tablet administered orally, once daily (QD). Unit dose strengths:
Altri nomi:
|
|
Comparatore placebo: Placebo
Placebo administered orally, once daily (QD). |
Placebo tablet matching baxdrostat, administered orally, once daily (QD). |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Seated Systolic Blood Pressure for 2 mg Baxdrostat
Lasso di tempo: At Week 12
|
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. |
At Week 12
|
|
Change From Baseline in Seated Systolic Blood Pressure for 1 mg Baxdrostat
Lasso di tempo: At Week 12
|
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. |
At Week 12
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Randomised Withdrawal Baseline (Week 24) in Seated Systolic Blood Pressure (SBP) for 2 mg Baxdrostat
Lasso di tempo: At Week 32
|
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. |
At Week 32
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|
Change From Baseline in Seated SBP for 2 mg Baxdrostat in the Resistant Hypertension Subpopulation
Lasso di tempo: At Week 12
|
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. |
At Week 12
|
|
Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 2 mg Baxdrostat
Lasso di tempo: At Week 12
|
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. |
At Week 12
|
|
Number of Participants Who Achieved Seated SBP < 130 mmHg for 2 mg Baxdrostat
Lasso di tempo: At Week 12
|
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. |
At Week 12
|
|
Change From Baseline in Seated SBP for 1 mg Baxdrostat in the Resistant Hypertension Subpopulation
Lasso di tempo: At Week 12
|
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. |
At Week 12
|
|
Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 1 mg Baxdrostat
Lasso di tempo: At Week 12
|
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. |
At Week 12
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Number of Participants Who Achieved Seated SBP < 130 mmHg for 1 mg Baxdrostat
Lasso di tempo: At Week 12
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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. |
At Week 12
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
- Flack 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.
- Schiffrin 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.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
22 novembre 2023
Completamento primario (Effettivo)
21 maggio 2025
Completamento dello studio (Effettivo)
10 ottobre 2025
Date di iscrizione allo studio
Primo inviato
6 settembre 2023
Primo inviato che soddisfa i criteri di controllo qualità
6 settembre 2023
Primo Inserito (Effettivo)
13 settembre 2023
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 novembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 ottobre 2026
Ultimo verificato
1 ottobre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- D6970C00002
- 2023-505499-32-00 (Identificatore di registro: EU CT number)
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
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.
Periodo di condivisione IPD
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.
Criteri di accesso alla condivisione IPD
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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .