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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07007793
Registration number
NCT07007793
Ethics application status
Date submitted
16/05/2025
Date registered
6/06/2025
Date last updated
3/09/2025
Titles & IDs
Public title
A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism
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Scientific title
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism
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Secondary ID [1]
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D6974C00001
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Universal Trial Number (UTN)
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Trial acronym
BaxPA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Primary Hyperaldosteronism
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Baxdrostat
Treatment: Drugs - Placebo
Experimental: Baxdrostat - Baxdrostat administered orally, once daily (QD).
Placebo comparator: Placebo - Matching placebo administered orally, once daily (QD).
Treatment: Drugs: Baxdrostat
Baxdrostat tablet administered orally, once daily (QD).
Treatment: Drugs: Placebo
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8
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Assessment method [1]
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To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) at Week 8
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Timepoint [1]
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At week 8
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Primary outcome [2]
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Achieving normalization of the Renin Angiotensin Aldosterone system (RAAS) at week 8
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Assessment method [2]
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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
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Timepoint [2]
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At week 8
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Secondary outcome [1]
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Change from Randomised withdrawal (RWD) baseline (Week 44) in seated Systolic Blood Pressure (SBP) at Week 52
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Assessment method [1]
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To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) 8 weeks after Randomised withdrawal (RWD)
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Timepoint [1]
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At week 52
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Secondary outcome [2]
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Percent change from RWD baseline (Week 44) in Plasma Renin Activity (PRA) at Week 52
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Assessment method [2]
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To assess the effect of baxdrostat versus placebo on the percent change in PRA 8 weeks after RWD
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Timepoint [2]
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At week 52
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Secondary outcome [3]
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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
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Assessment method [3]
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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
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Timepoint [3]
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At week 8
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Secondary outcome [4]
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Percent change from baseline in PRA at Week 8
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Assessment method [4]
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To assess the effect of baxdrostat versus placebo on the percent change from baseline in PRA at Week 8
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Timepoint [4]
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At week 8
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Secondary outcome [5]
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Achieving 24-hour urine aldosterone < 10 µg at Week 8 in participants with 24-hour urine aldosterone = 10 µg at baseline
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Assessment method [5]
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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
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Timepoint [5]
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At week 8
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Secondary outcome [6]
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Change from baseline in 24-hour urine albumin at Week 8
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Assessment method [6]
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To assess the effect of baxdrostat versus placebo on 24-hour urine albumin at Week 8
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Timepoint [6]
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At week 8
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Eligibility
Key inclusion 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 orpotassium sparing diuretics per study requirement for participantstaking 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 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.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- If not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP > 170 mmHg or mean seated DBP =110 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 2weeks prior to Randomisation.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/08/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
18/02/2028
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Brisbane
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Recruitment hospital [2]
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Research Site - Clayton
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Research Site - Perth
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Recruitment postcode(s) [1]
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4102 - Brisbane
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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6000 - Perth
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Recruitment outside Australia
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California
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
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Summary
Brief summary
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 unsuppression of Plasma Renin Activity (PRA) in approximately 180 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 to based on clinical response and tolerability. The study is planned to be conducted globally in approximately 90 study centres and approximately 12 countries.
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Trial website
https://clinicaltrials.gov/study/NCT07007793
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Phone
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Fax
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Email
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Contact person for public queries
Name
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AstraZeneca Clinical Study Information Center
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Address
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Phone
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1-877-240-9479
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
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.
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Available to whom?
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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivili.org/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07007793
Download to PDF