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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Primary Hyperaldosteronism
Date of first enrollment	25/09/2025
Target sample size	15
Countries of recruitment	Canada,Japan,United States,Japan,Australia,Japan,France,Japan,Germany,Japan,Taiwan,Japan,United Kingdom,Japan,China,Japan,India,Japan,Italy,Japan,Spain,Japan
Study type	Interventional
Intervention(s)	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, participants will be considered for up-titration to 4 mg once daily based on drug tolerability and efficacy evaluation. The primary endpoints will be measured at the end of Week 8. After participants complete the 8-week double-blind treatment period, they will enter an open-label period with baxdrostat once daily for 36 weeks (Week 8 to Week 44): - Participants who received placebo during the double-blind period will start the open-label period at 2 mg baxdrostat and will be considered for up-titration to 4 mg at Week 10. - Participants who received 2 mg baxdrostat at the end of the double-blinded period will remain at 2 mg during the open-label period. - Participants who received 4 mg baxdrostat at the end of the double-blind period will remain on 4 mg during the open-label period. To maintain the blind from the initial treatment group randomisation, the up-titration evaluation outcome, and resulting dose recommendation in both the double-blind and open-label periods will be blinded. Participants on the 4 mg dose can be down-titrated to 2 mg for safety reasons at any time. Participants who do not tolerate the 2 mg dose at any time during the study will be discontinued from treatment but will continue in the study. At the end of the open-label period (Week 44), study participants will enter an 8-week blinded RWD period, during which they will be randomised 1:1 to either remain on current treatment (baxdrostat 2 or 4 mg once daily) or withdraw baxdrostat treatment and receive placebo. At Week 52, the RWD secondary endpoints will be measured, and all participants will discontinue study medication.

Outcome(s)

Primary Outcome

- 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

Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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 < 5.0 mmol/L at Screeningdetermined 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 or more.
Exclude criteria	- If not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP > 170 mmHg or mean seated DBP 110 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.