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Baxdrostat for primary aldosteronism — testing a once‑daily oral medicine for blood pressure and hormone control.

A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism

Phase 3 Interventional AstraZeneca · NCT07007793

This Phase III trial will test whether once‑daily baxdrostat lowers seated blood pressure and restores normal renin–angiotensin–aldosterone system function in adults with primary aldosteronism.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Locations89 sites (Los Angeles, California and 88 other locations)
Trial IDNCT07007793 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double‑blind, placebo‑controlled Phase III trial enrolling about 180 adults with confirmed primary aldosteronism. Participants will be randomized to once‑daily baxdrostat or matching placebo, with dose up‑titration after two weeks based on clinical response and tolerability. Key outcomes include reduction in seated systolic blood pressure and normalization of the renin–angiotensin–aldosterone system, alongside safety and tolerability monitoring. The trial will include patients with and without prior mineralocorticoid receptor antagonist therapy and is planned at roughly 90 centers across 12 countries.

Who should consider this trial

Good fit: Adults (≥18) with a documented diagnosis of primary aldosteronism, seated systolic BP 135–170 mmHg, eGFR ≥45 mL/min/1.73 m2, serum potassium 3.0–5.0 mmol/L, on a stable antihypertensive regimen and willing to stop MRAs or potassium‑sparing diuretics if required are ideal candidates.

Not a fit: Patients with uncontrolled severe hypertension (seated SBP >170 mmHg or DBP >105 mmHg), eGFR <45 mL/min/1.73 m2, persistent low potassium, or those unable or unwilling to attend visits or stop MRAs are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, baxdrostat could provide a well‑tolerated oral option that lowers blood pressure and corrects aldosterone excess for people with primary aldosteronism, potentially reducing reliance on other drugs or procedures.

How similar studies have performed: Earlier‑phase studies of baxdrostat and other aldosterone‑synthase inhibitors have shown promising blood‑pressure and aldosterone‑lowering effects, but large randomized phase III confirmation is still limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male or female participants must be ≥ 18 years of age
* Participants with a documented diagnosis of PA that fulfils the criteria defined in the 2016 or 2025 Endocrine Society Guidelines.
* Participants willing and able to cease dosing of MRA or potassium sparing diuretics per study requirement for participants taking an MRA or potassium sparing diuretic at Screening.
* eGFR ≥ 45 mL/min/1.73m2 at Screening
* Serum potassium level ≥ 3.0 and \< 5.0 mmol/L at Screening determined as per the central laboratory.
* Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomisation
* Mean seated SBP on AOBPM of ≥ 135 mmHg and ≤ 170 mmHg and mean DBP of

  ≤ 105 mmHg.
* Serum potassium (local lab) \> 3.0 mmol/L at randomization.

Exclusion Criteria:

\- If not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \> 170 mmHg or mean seated DBP \>105 mmHg (on AOBPM).

If taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \> 160 mmHg or mean seated DBP ≥ 100 mmHg.

* Previous surgical intervention for an adrenal adenoma or have a planned adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.
* Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
* Serum sodium level \< 135 mmol/L at Screening, determined as per central laboratory.
* New York Heart Association functional HF class IV at Screening.
* Persistent atrial fibrillation.
* Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomisation.

Where this trial is running

Los Angeles, California and 88 other locations

+39 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Primary HyperaldosteronismPrimary hyperaldosteronismPrimary aldosteronismPABaxdrostatCIN-107Aldosterone
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.