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

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).

Timeline

Start

2023-11-22

Primary completion

2025-05-21

Completion

2025-10-10

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.
• 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.

Drugs

Indications