BridgeMD
A trial to learn how safe baxdrostat is and how well it works in adults with primary aldosteronism
EU CTIS ID: 2025-520740-16-00
What this study is testing
1. To assess the effect of baxdrostat versus placebo on seated SBP at Week 8 2. To assess the effect of baxdrostat versus placebo on achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) at week 8
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- India
- United Kingdom
- United States
- Taiwan
- Canada
- China
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; India; United Kingdom; United States; Taiwan; Canada and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.