Recruiting
Phase 3

Baxdrostat

Sponsor:

AstraZeneca

Code:

NCT07007793

Conditions

Primary Hyperaldosteronism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Baxdrostat

Placebo

Study Details

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 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.

Conditions

Primary Hyperaldosteronism

Study ID

NCT07007793

Start date

Aug 7, 2025

Status verified date

Jul, 2026

Completion date

Aug 14, 2028

Anticipated

Primary completion date

Aug 13, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Baxdrostat

Baxdrostat administered orally, once daily (QD).

placebo comparator: Placebo

Matching placebo administered orally, once daily (QD).

Interventions

Baxdrostat

Baxdrostat tablet administered orally, once daily (QD).

Placebo

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

Primary outcome measure

  • Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8 [ Time Frame: At week 8 ]
  • Achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) at week 8. [ Time Frame: At week 8 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Chicago, Illinois, United States, 60611

Research Site

Recruiting

Olive Branch, Mississippi, United States, 38654

Research Site

Recruiting

Columbia, South Carolina, United States, 29203

Research Site

Recruiting

Calgary, Alberta, Canada, T2T 5C7

Research Site

Recruiting

Ottawa, Ontario, Canada, K1H 7W9

Research Site

Recruiting

Toronto, Ontario, Canada, M4G 3E8

Research Site

Recruiting

Montreal, Quebec, Canada, H4J 1C5

More Information

Sponsor

AstraZeneca

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Primary hyperaldosteronism
  • Primary aldosteronism
  • PA
  • Baxdrostat
  • CIN-107
  • Aldosterone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-07-06.