A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
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 ≥ 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).
Timeline
- Start
- 2024-03-01
- Primary completion
- 2025-08-17
- Completion
- 2025-08-17
Outcome
Met primary endpoint
paper the estimated placebo-corrected difference was -14·0 mm Hg (-17·2 to -10·8; p<0·0001). PMID 41794437 ↗
paper Baxdrostat significantly reduced 24 h ambulatory SBP versus placebo in patients with resistant hypertension PMID 41794437 ↗
release “Baxdrostat met the primary endpoint in the Bax24 Phase III trial, delivering clinically meaningful and consistent blood pressure reductions in patients with treatment-resistant hypertension.” astrazeneca.com ↗
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.
- Dwyer 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Baxdrostat | Small molecule | 2 mg | Oral |