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Baxdrostat for Primary Aldosteronism

This study is testing a drug called Baxdrostat to see if it can safely and effectively lower blood pressure and normalize hormone levels in people with primary aldosteronism (PA). PA is a condition where your body makes too much of a hormone called aldosterone, which can lead to high blood pressure. You would receive either Baxdrostat or a placebo (an inactive pill) once a day. The study aims to enroll about 250 adults aged 18 and older who have been diagnosed with PA. Success in this study means seeing a reduction in your seated blood pressure and your hormone levels returning to normal after 8 weeks. The current recruitment status is unclear.

Study design
This is a Phase III, randomized, double-blind, placebo-controlled study involving about 250 participants. This means you would be randomly assigned to receive either Baxdrostat or a placebo, and neither you nor your doctor would know which one you are taking.
What's involved
You would take Baxdrostat or a placebo tablet once daily. The dose may be adjusted after 2 weeks based on how you respond and tolerate the medication.
Compensation
Not stated in the trial record.
Follow-up
The primary goals of the study are measured at Week 8.

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NCT07007793

A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~250 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:BaxdrostatPlacebo

At a glance

Recruiting sites
19 of 89 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8
Measured over At week 8
+1 more outcome measured

Conditions

Primary Hyperaldosteronism

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Where it's being run

89 sites across 28 states
China13
France7
Japan7
Germany6
India6
Italy6
Taiwan6
Spain5

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Serum potassium (local lab) \> 3.0 mmol/L at randomization.

Exclusion

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.

What this trial measures

  • Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8At week 8

    To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) at Week 8

  • Achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) at week 8.At week 8

    To assess the effect of baxdrostat vs placebo on achieving normalization of renin at week 8