Primary HyperaldosteronismPhase 3BaxPANCT07007793
Parent Study: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism Sub-study: A Follow-up Substudy After Completion of the BaxPA Main Study.
A Phase 3 study testing Baxdrostat in people with Primary Hyperaldosteronism, run by AstraZeneca at 76 sites in 12 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperaldosteronism
- What is being tested?
- Baxdrostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 76 sitesin 12 countries
- Study dates
- 7 Aug 2025to 14 Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
- Completed the BaxPA main study through the End of Study visit and was randomised and treated during the Randomised Withdrawal period.
Who cannot join
- 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.
Show all 10Show fewer
- Persistent atrial fibrillation.
- Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomisation.
- Substudy
- Not applicable
Trial locations and contacts
76 sites in 12 countries.
76 sites in 12 countries
United States15 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Baltimore, Maryland, 21287
Research Site
Bethlehem, Pennsylvania, 18017
Research Site
Boston, Massachusetts, 02111
Research Site
Boston, Massachusetts, 02115
Research Site
Cleveland, Ohio, 44195
Research Site
Columbia, South Carolina, 29203
Research Site
Columbus, Ohio, 43210
Research Site
Dallas, Texas, 75390
Research Site
Farmington, Connecticut, 06030
Research Site
Olive Branch, Mississippi, 38654
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Rochester, Minnesota, 55902
Research Site
San Francisco, California, 94110
Research Site
Springfield, Illinois, 62702
China11 sites
Research Site
Beijing, 100034
Research Site
Beijing, 100044
Research Site
Beijing, 100191
Research Site
Changsha, 430033
Research Site
Chengdu, 610041
Research Site
Chongqing, 400042
Research Site
Nanjing, 2100008
Research Site
Shanghai, 200025
Research Site
Tianjin, 300050
Research Site
Wuhan, 430030
Research Site
Wuhan, 430060
Japan7 sites
Research Site
Kawasaki-shi, 216-8511
Research Site
Kodaira-shi, 187-8510
Research Site
Minatoku, 108-8329
Research Site
Ōta-ku, 143-8541
Research Site
Shinjuku-ku, 162-8666
Research Site
Yokohama, 230-8765
Research Site
Yufu-shi, 879-5593
France6 sites
Research Site
Amiens, 80054
Research Site
Bois-Guillaume, 76230
Research Site
Bordeaux, 33076
Research Site
Lille, 59037
Research Site
Paris, 75018
Research Site
Paris, 75908
Italy6 sites
Research Site
Bologna, 40138
Research Site
Brescia, 25123
Research Site
Florence, 50134
Research Site
Milan, 20149
Research Site
Milan, 20162
Research Site
Torino, 10126
Germany5 sites
Research Site
Berlin, 12203
Research Site
Düsseldorf, 40225
Research Site
Kaiserslautern, 67655
Research Site
München, 80336
Research Site
Würzburg, 97080
India5 sites
Research Site
Belagavi, 590010
Research Site
Delhi, 110029
Research Site
Hyderabad, 500012
Research Site
Kolkata, 700020
Research Site
Mumbai, 400012
Spain5 sites
Research Site
Barcelona, 08036
Research Site
Madrid, 28034
Research Site
Madrid, 28040
Research Site
Madrid, 28046
Research Site
Seville, 41013
United Kingdom5 sites
Research Site
Cambridge, CB2 0QQ
Research Site
Cardiff, CF14 4XW
Research Site
Dundee, DD1 9SY
Research Site
London, EC1A 7BE
Research Site
London, SE1 9RT
Canada4 sites
Research Site
Calgary, Alberta, T2T 5C7
Research Site
Montreal, Quebec, H4J 1C5
Research Site
Ottawa, Ontario, K1H 7W9
Research Site
Toronto, Ontario, M4G 3E8
Taiwan4 sites
Research Site
Taichung, 40705
Research Site
Taipei, 10002
Research Site
Taoyuan, 333
Research Site
Zhubei, 302
Australia3 sites
Research Site
Brisbane, 4102
Research Site
Clayton, 3168
Research Site
Perth, 6000
About this study
Official title: Parent Study: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism Sub-study: A Substudy to Describe PA Disease Characteristics After Completion of the BaxPA Main Study
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.
Read more
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:
- The study duration will be up to 70 ± 9 weeks.
- The visits will be at Week 13 (Visit 2), Week 26 (Visit 3), Week 52 (Visit 4), and up to Week 70 (Visit 5).
- Conditions
- Primary Hyperaldosteronism
- Being tested
- Baxdrostat, Placebo
- Keywords
- Primary hyperaldosteronism, Primary aldosteronism, PA, Baxdrostat, CIN-107, Aldosterone
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaxdrostatDrug
Also called CIN-107
Baxdrostat tablet administered orally, once daily (QD).
PlaceboDrug
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
| Study group | Role | What they receive |
|---|---|---|
| Baxdrostat | Experimental | Baxdrostat administered orally, once daily (QD). Receives: Drug: Baxdrostat |
| Placebo | Placebo comparator | Matching placebo administered orally, once daily (QD). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At week 8
Secondary outcomes (6)
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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: At week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start7 Aug 2025
- Primary completion27 Jul 2027 (estimated)
- Study completion14 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperaldosteronismStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007793
- Sponsor's protocol ID
- D6974C00001
- Acronym
- BaxPA
- Status last verified
- Oct 2026
- First submitted
- 16 May 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Study: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism Sub-study: A Substudy to Describe PA Disease Characteristics After Completion of the BaxPA Main Study
- ClinicalTrials.gov ID
- NCT07007793
- Acronym / sponsor ID
- BaxPA / D6974C00001
- Conditions
- Primary Hyperaldosteronism
- Keywords
- Primary hyperaldosteronism, Primary aldosteronism, PA, Baxdrostat, CIN-107, Aldosterone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 212 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 27 Jul 2027 (estimated)
- Study completion
- 14 Aug 2028 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The study duration will be up to 70 ± 9 weeks.
- The visits will be at Week 13 (Visit 2), Week 26 (Visit 3), Week 52 (Visit 4), and up to Week 70 (Visit 5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baxdrostat | Experimental | Drug: BaxdrostatBaxdrostat administered orally, once daily (QD). |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo administered orally, once daily (QD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaxdrostatAlso: CIN-107Baxdrostat tablet administered orally, once daily (QD). | Drug | Baxdrostat |
| PlaceboPlacebo tablet matching baxdrostat, administered orally, once daily (QD). | Drug | Placebo |
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 renin at week 8 in participants with dysregulated renin at baseline
Time frame: At week 8
To assess the effect of baxdrostat vs placebo on achieving normalization of renin at week 8, in participants with dysregulated renin at baseline
6 secondary outcomes
Percent change from RWD baseline (Week 44) in Direct Renin Concentration (DRC) at Week 52
Time frame: At week 52
Change from Randomised withdrawal (RWD) baseline (Week 44) in seated Systolic Blood Pressure (SBP) at Week 52
Time frame: At week 52
Percent 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
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
Time frame: At week 8
Percent change from baseline in 24-hour urine albumin at Week 8
Time frame: At week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
76 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Baxdrostat in people with Primary Hyperaldosteronism, run by AstraZeneca at 76 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States, China, Japan, France, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8 (time frame: At week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.