Primary Hyperaldosteronism
Conditions
Interventions
Eligible participants will be randomised in a 1:1 ratio to receive either baxdrostat 2 mg or matching
placebo tablets once daily for the first 2 weeks of an 8-week double-blind period.
At Week 2, part
Sponsors
Ageishi Yuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female participants must be 18 years of age or more - 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 participantstaking an MRA or potassium sparing diuretic at Screening. - eGFR 45 mL/min/1.73m2 or more at Screening Serum potassium level 3.0 or more and 3.0 mmol/L at randomization
Exclusion criteria
Exclusion criteria: - f not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP > 170 mmHg or mean seated DBP 105 mmHg or less (on AOBPM). If taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP > 160 mmHg or mean seated DBP 100 mmHg or less. - 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 2weeks prior to Randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8 [Time Frame: At 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 [Time Frame: At week 8] _ To assess the effect of baxdrostat versus placebo on achieving normalization of the Renin Angiotensin Aldosterone system (RAAS) at week 8, in participants with dysregulated RAAS at baseline | — |
Countries
Australia, Canada, China, France, Germany, India, Italy, Japan, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactYuji Ageishi
Astrazeneka K.K
Outcome results
None listed