NCT06034743: BaxHTN

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

Completed Phase 3 Last updated 10 November 2025

What this trial tests

Phase 3 trial testing Baxdrostat in Uncontrolled Hypertension in 796 participants. Completed in 10 October 2025.

Timeline

22 November 2023

Primary endpoint
21 May 2025

10 October 2025

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	796
Start date	22 November 2023
Primary completion	21 May 2025
Estimated completion	10 October 2025
Sites	263 locations across Italy, Japan, Malaysia, Taiwan, Vietnam, Poland, South Korea, Denmark

Drugs / interventions tested

• Baxdrostat — full drug profile →
• Placebo

Conditions studied

• Uncontrolled Hypertension — all drugs for Uncontrolled Hypertension →
• Resistant Hypertension — all drugs for Resistant Hypertension →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Uncontrolled Hypertension or Resistant Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension.
   Flack JM, Azizi M, Brown JM, Dwyer JP, et al · · 2025 · cited 54× · PMID 40888730 · DOI 10.1056/nejmoa2507109
2. Aldosterone Synthase Inhibitors for Cardiorenal Protection: Ready for Prime Time?
   Mazzieri A, Timio F, Patera F, Trepiccione F, et al · · 2024 · cited 16× · PMID 39557029 · DOI 10.1159/000542621
3. New pharmacological agents and novel cardiovascular pharmacotherapy strategies in 2023.
   Tamargo J, Agewall S, Borghi C, Ceconi C, et al · · 2024 · cited 13× · PMID 38379024 · DOI 10.1093/ehjcvp/pvae013
4. Aldosterone Synthase Inhibitors for Resistant Hypertension: Pharmacological Insights - A Systematic Review.
   Cicero AFG, Tocci G, Avagimyan A, Penson P, et al · · 2025 · cited 7× · PMID 40885884 · DOI 10.1007/s40265-025-02229-2
5. Baxdrostat for uncontrolled and resistant hypertension: rationale and design of the Phase 3 clinical trials BaxHTN, BaxAsia, and Bax24.
   Flack JM, Azizi M, Brown JM, Dwyer JP, et al · · 2025 · cited 7× · PMID 40850955 · DOI 10.1038/s41440-025-02297-7
6. The Emerging Role of Aldosterone Synthase Inhibitors in Overcoming Renin-Angiotensin-Aldosterone System Therapy Limitations: A Narrative Review.
   Patel SK, Teoh H, Saunthar A, Yau TM, et al · · 2025 · cited 6× · PMID 40901557 · DOI 10.15420/cfr.2025.09
7. New pharmacological agents and novel cardiovascular pharmacotherapy strategies in 2024.
   Tamargo J, Agewall S, Ambrosio G, Borghi C, et al · · 2025 · cited 6× · PMID 40058879 · DOI 10.1093/ehjcvp/pvaf012
8. Evaluating the role of aldosterone synthesis on adrenal cell fate.
   Aminuddin A, Brown MJ, Azizan EA. · · 2024 · cited 4× · PMID 39170743 · DOI 10.3389/fendo.2024.1423027