Resistant HypertensionPhase 3Bax24NCT06168409
A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
A Phase 3 study testing Baxdrostat in people with Resistant Hypertension, run by AstraZeneca at 102 sites in 22 countries.
Trial summary
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- 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
- 218 participants
- Where
- 102 sitesin 22 countries
- Study dates
- 1 Mar 2024to 17 Aug 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
- Participant must be ≥ 18 years old, at the time of signing the informed consent.
- Mean seated SBP on AOBPM of ≥ 140 mmHg and < 170 mmHg at Screening.
- 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, for at least 4 weeks prior to screening. Beta blockers used to treat other conditions (ie, migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.
- Have eGFR ≥ 45 mL/min/1.73 m2 at Screening.
- Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening, determined as per central laboratory
- Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation.
Who cannot join
- Mean seated SBP on AOBPM ≥ 170 mmHg.
- Mean seated DBP on AOBPM ≥ 110 mmHg.
- Serum sodium level < 135 mmol/L at Screening, as per central laboratory.
- Participant 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 HF class IV.
- Persistent atrial fibrillation.
Trial locations and contacts
102 sites in 22 countries.
102 sites in 22 countries
United States16 sites
Research Site
Brownsville, Texas, 78526
Research Site
Corpus Christi, Texas, 78404
Research Site
Fort Wayne, Indiana, 46804
Research Site
Greenville, North Carolina, 27834
Research Site
Hollywood, Florida, 33024
Research Site
Jacksonville, North Carolina, 28546
Research Site
Kinston, North Carolina, 28504
Research Site
Lake Worth, Florida, 33467
Research Site
Lampasas, Texas, 76550
Research Site
Langhorne, Pennsylvania, 19047
Research Site
Lexington, Kentucky, 40503
Research Site
New Bern, North Carolina, 28562
Research Site
Port Charlotte, Florida, 33952
Research Site
Surprise, Arizona, 85374
Research Site
The Bronx, New York, 10455
Research Site
Wilmington, North Carolina, 28401
Argentina8 sites
Research Site
CABA, C1061
Research Site
CABA, C1425HFA
Research Site
Capital Federal, C1060ABN
Research Site
Córdoba, X5003DCP
Research Site
Lanús Este, B1824KAJ
Research Site
Rosario, S2000PBJ
Research Site
San Miguel de Tucumán, 4000
Research Site
San Vicente, 5006
United Kingdom8 sites
Research Site
Corby, NN17 2UR
Research Site
London, E1 1BB
Research Site
London, W6 7HY
Research Site
Prescot, L35 5DR
Research Site
Swindon, SN3 6BB
Research Site
Thetford, IP24 1JD
Research Site
Weston-super-Mare, BS24 7PR
Research Site
Yate, BS37 4AX
Canada7 sites
Research Site
Cambridge, Ontario, N1R 6V6
Research Site
Chicoutimi, Quebec, G7H 7K9
Research Site
Edmonton, Alberta, T6G 2C8
Research Site
North Vancouver, British Columbia, V7M 2H4
Research Site
Terrebonne, Quebec, J6X 4P7
Research Site
Toronto, Ontario, M6G 1M2
Research Site
Waterloo, Ontario, N2T 0C1
Spain7 sites
Research Site
Barcelona, 08003
Research Site
Barcelona, 08036
Research Site
Madrid, 28040
Research Site
Madrid, 28041
Research Site
Santa Coloma de Gramenet, 08923
Research Site
Terrassa (Barcelona), 08221
Research Site
Valencia, 46010
Poland6 sites
Research Site
Bialystok, 15-540
Research Site
Gdansk, 80-214
Research Site
Krakow, 30-688
Research Site
Lodz, 91-002
Research Site
Poznan, 61-848
Research Site
Warsaw, 04-628
Hungary5 sites
Research Site
Budapest, 1115
Research Site
Budapest, 1148
Research Site
Kalocsa, 6300
Research Site
Nyíregyháza, 4400
Research Site
Pécs, 7635
Thailand5 sites
Research Site
Bangkok, 10330
Research Site
Bangkok, 10400
Research Site
Bangkok, 10700
Research Site
Chiang Mai, 50200
Research Site
Khon Kaen, 40002
Turkey (Türkiye)5 sites
Research Site
Adana, 01060
Research Site
Ankara, 06230
Research Site
Kahramanmaraş, 46100
Research Site
Kayseri, 38039
Research Site
Odunpazari, 26080
Czechia4 sites
Research Site
Benešov, 256 01
Research Site
Brandýs nad Labem, 250 01
Research Site
Broumov, 55001
Research Site
Louny, 440 01
Germany4 sites
Research Site
Bad Homburg, 61348
Research Site
Berlin, 12203
Research Site
Frankfurt, 60590
Research Site
Kaiserslautern, 67655
Bulgaria3 sites
Research Site
Sofia, 1527
Research Site
Sofia, 1618
Research Site
Sofia, 1680
Greece3 sites
Research Site
Athens, 11527
Research Site
Attica, 11527
Research Site
Thessaloniki, 54642
Malaysia3 sites
Research Site
Kota Bharu, 15586
Research Site
Muar town, 84000
Research Site
Sarawak Miri, 98000
Slovakia3 sites
Research Site
Brezno, 977 01
Research Site
Košice, 04022
Research Site
Svidník, 08901
Taiwan3 sites
Research Site
New Taipei City, 220
Research Site
Taipei, 11217
Research Site
Taoyuan, 333
Vietnam3 sites
Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000
Research Site
Hochiminh City, 700000
Philippines2 sites
Research Site
Angeles City, 2009
Research Site
Iloilo City, 5000
Saudi Arabia2 sites
Research Site
Riyadh, 11426
Research Site
Riyadh, 11462
South Africa2 sites
Research Site
Cape Town, 7500
Research Site
Durban, 4001
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).
Read the detailed description
This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg baxdrostat versus placebo, administered once a day (QD) orally, on the reduction of ambulatory SBP in participants with rHTN, defined as BP targets not being achieved in an individual despite the use of at least 3 antihypertensive agents of different classes (at maximum tolerated dose in the judgement of the Investigator), one of which is a diuretic.
- Conditions
- Resistant Hypertension
- Being tested
- Baxdrostat, Placebo
- Keywords
- Hypertension, Resistant hypertension, Blood pressure, Baxdrostat, CIN-107, Aldosterone, Aldosterone synthase, Aldosterone synthase inhibitor
- 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 strength:
- 2 mg per tablet.
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 |
| 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.
Least Square Mean Difference for Change From Baseline in Ambulatory 24-hour Average SBP at Week 12: Treatment Policy Strategy
Measured: Baseline to week 12
Secondary outcomes (9)
Change From Baseline in Ambulatory Night-time Average SBP (mmHg) at Week 12 LS Means
Measured: Baseline to week 12
Change From Baseline in Ambulatory Daytime Average SBP (mmHg) at Week 12
Measured: Baseline to week 12
Change From Baseline in Seated SBP (mmHg) at Week 12
Measured: Baseline to week 12
Achieving Ambulatory 24-hour Average SBP of < 130 mmHg at Week 12
Measured: Baseline to week 12
Change From Baseline in Ambulatory 24-hour Average DBP (mmHg) at Week 12
Measured: Baseline to week 12
Change From Baseline in Ambulatory Night-time Average DBP (mmHg) at Week 12
Measured: Baseline to week 12
Change From Baseline in Ambulatory Daytime Average DBP (mmHg) at Week 12
Measured: Baseline to week 12
Change From Baseline in Seated DBP (mmHg) at Week 12
Measured: Baseline to week 12
Achieving a Nocturnal SBP Dipping of >= 10% at Week 12
Measured: Baseline to 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 Dec 2023
- Study start1 Mar 2024
- Primary completion17 Aug 2025
- Study completion17 Aug 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 Resistant 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
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168409
- Sponsor's protocol ID
- D6970C00009
- Other IDs
- 2023-507640-36-00, 2023
- Acronym
- Bax24
- Status last verified
- Aug 2026
- First submitted
- 5 Dec 2023
- Last updated
- 6 Aug 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
Azizi M, Brown JM, Dwyer JP, Flack JM, Jones ESW, Kurlyandskaya R, Li H, Birve F, Lihn AS, Perl S, Schlaich MP, Shibata H, Wang JG, Williams B; Bax24 investigators. Effect of baxdrostat on ambulatory blood pressure in patients with resistant hypertension (Bax24): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2026 Mar 7;407(10532):988-999. doi: 10.1016/S0140-6736(25)02549-8.
PubMed 41794437Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2026 Feb 1;37(2):299-311. doi: 10.1681/ASN.0000000849. Epub 2025 Sep 6.
PubMed 40913594Flack 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 40850955