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NCT Number: NCT07007793

A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Brisbane, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

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.

  • 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.

Treatment and study plan

baxdrostat

Drug

Baxdrostat tablet administered orally, once daily (QD).

Other names: CIN-107

Placebo

Drug

Placebo tablet matching baxdrostat, administered orally, once daily (QD).

Primary outcomes

  1. 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

  2. Achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) at week 8.

    Time frame: At week 8

    To assess the effect of baxdrostat vs placebo on achieving normalization of renin at week 8

Secondary outcomes

  1. Percent change from RWD baseline (Week 44) in Direct Renin Concentration (DRC) at Week 52

    Time frame: At week 52

    To assess the effect of baxdrostat versus placebo on the percent change in DRC 8 weeks after the start of RWD

  2. Change from Randomised withdrawal (RWD) baseline (Week 44) in seated Systolic Blood Pressure (SBP) at Week 52

    Time frame: 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)

  3. Achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) at week 8.

    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 RAAS at baseline.

  4. 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

    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

  5. 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

    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

  6. Percent change from baseline in 24-hour urine albumin at Week 8

    Time frame: At week 8

    To assess the effect of baxdrostat versus placebo on 24-hour urine albumin at Week 8

Other outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: up to 54 weeks

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism

Acronym: BaxPA

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 6, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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