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Tests treatment safety and results for Primary Hyperaldosteronism
Official title A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism
ClinicalTrials.gov ID: NCT07007793
What this study is testing
What is Baxdrostat?
Baxdrostat is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for primary hyperaldosteronism.
Also referred to as CIN-107.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 250 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- 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.
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...
- Previous surgical intervention for an adrenal adenoma or have a planned adrenalectomy, renal nerve denervation, or adrenal ablative procedure during...
- Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated...
- 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 \>...
- 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
- Los Angeles, California, United States
- San Francisco, California, United States
- Farmington, Connecticut, United States
- Chicago, Illinois, United States
- Springfield, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- Olive Branch, Mississippi, United States
- Kansas City, Missouri, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Bethlehem, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Columbia, South Carolina, United States
- Brownsville, Texas, United States
- Dallas, Texas, United States
+ 58 more site(s).
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Farmington, Connecticut, United States; Chicago, Illinois, United States; Springfield, Illinois, United States; Baltimore, Maryland, United States and 72 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 ClinicalTrials.gov; the study team decides eligibility.