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

AstraZeneca

Status and phase: Enrolling; Phase 3

Conditions: Primary Hyperaldosteronism

Treatments: Drug: Placebo; Drug: Baxdrostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT07007793

D6974C00001

Details and patient eligibility

About

This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of baxdrostat versus placebo, on the reduction of Seated Blood Pressure (SBP) and achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) in approximately 180 participants ≥ 18 years of age with Primary Aldosteronism (PA), with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics.

Baxdrostat (or placebo) will be administered once daily, up-titrated after 2 weeks based on clinical response and tolerability.

The study is planned to be conducted globally in approximately 90 study centres and 12 countries.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

Baxdrostat

Experimental group

Description:

Baxdrostat administered orally, once daily (QD).

Treatment:

Drug: Baxdrostat

Placebo

Placebo Comparator group

Description:

Matching placebo administered orally, once daily (QD).

Treatment:

Drug: Placebo