IRB Study Number 25-959
Status Recruiting
Phase Phase 3
Institute Endocrinology and Metabolism Institute
Description
This is a study that is intended to evaluate the efficacy, safety, and tolerability of baxdrostat once daily (2 mg titrated to 4 mg) compared with placebo in participants with PA.
Inclusion Criteria
-18 years or older
-Serum potassium > 3.0 mmol/L within the last 6 months
-eGFR ≥ 45 mL/min/1.73m2 at Screening
-Participants with a documented diagnosis of PA that fulfils the criteria defined in the 2016 or 2025 Endocrine Society Guidelines.
-Are 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.
Exclusion Criteria
-If not taking an MRA or potassium-sparing diuretic at Screening: Mean seated SBP > 180 mmHg or mean seated DBP ≥ 110 mmHg (on AOBPM).
-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.
-Medical history of stroke, acute coronary syndrome, hypertensive encephalopathy, or hospitalization for HF within 6 months prior to Screening
