A Phase 3 interventional study of Baxdrostat and Placebo in Primary Hyperaldosteronism, sponsored by AstraZeneca. Active, not recruiting at 76 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
Parent study:
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.
The study is planned to be conducted globally in approximately 90 study centres and 12 countries.
Sub-study:
The purpose of this study is to describe PA disease characteristics after completing baxdrostat treatment in participants with PA. Investigational medicinal product (IMP) will not be administered during the substudy.
Study details include:
201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.
This study's enrollment of 212 is above the median of 63 across 94 interventional studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 16, 2026. See what changed
Parent study
Inclusion Criteria:
Mean seated SBP on AOBPM of ≥ 135 mmHg and ≤ 170 mmHg and mean DBP of
≤ 105 mmHg.
Exclusion Criteria:
- 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.
Substudy
Inclusion Criteria:
Completed the BaxPA main study through the End of Study visit and was randomised and treated during the Randomised Withdrawal period.
Exclusion Criteria:
Not applicable
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Baxdrostat administered orally, once daily (QD).
Drug: Baxdrostat
Matching placebo administered orally, once daily (QD).
Drug: Placebo
Baxdrostat tablet administered orally, once daily (QD).
Also known as: CIN-107
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8
To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) at Week 8
Time frame: At week 8
Achieving normalization of renin at week 8 in participants with dysregulated renin at baseline
To assess the effect of baxdrostat vs placebo on achieving normalization of renin at week 8, in participants with dysregulated renin at baseline
Time frame: At week 8
Percent change from RWD baseline (Week 44) in Direct Renin Concentration (DRC) at Week 52
To assess the effect of baxdrostat versus placebo on the percent change in DRC 8 weeks after the start of RWD
Time frame: At week 52
Change from Randomised withdrawal (RWD) baseline (Week 44) in seated Systolic Blood Pressure (SBP) at Week 52
To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) 8 weeks after the start of Randomised withdrawal (RWD)
Time frame: At week 52
Percent change from baseline in Renin at week 8
To assess the effect of baxdrostat versus placebo in the change from baseline in renin at week 8.
Time frame: At week 8
Achieving serum potassium ≥ 3.7 mmol/L without potassium supplementation at Week 8 in participants with serum potassium < 3.7 mmol/L or potassium supplementation at baseline
To assess the effect of baxdrostat versus placebo on achieving serum potassium ≥ 3.7 mmol/L without potassium supplementation at Week 8 in participants with serum potassium \< 3.7 mmol/L or potassium supplementation at baseline
Time frame: At week 8
Achieving 24-hour urine aldosterone < 10 μg at Week 8 in participants with 24-hour urine aldosterone ≥ 10 μg at baseline
To assess the effect of baxdrostat versus placebo on achieving 24-hour urine aldosterone \< 10 μg at Week 8 in participants with 24-hour urine aldosterone ≥ 10 μg at baseline
Time frame: At week 8
Percent change from baseline in 24-hour urine albumin at Week 8
To assess the effect of baxdrostat versus placebo on 24-hour urine albumin at Week 8
Time frame: At week 8
Number of participants with adverse events (AEs)
To assess the safety and tolerability of baxdrostat. Occurrence of Adverse Events (AEs), Serious Adverse Events (SAEs), deaths, AEs leading to discontinuation of IMP and adverse events of special interest (AESIs) (hyperkalemia and hyponatremia)
Time frame: up to 54 weeks
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivili.org
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Baxdrostat