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Clinical Trials in France / NCT07007793
Active, not recruiting Phase 3

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.

NCT07007793 · tracked via the Priya Life Science France tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2025-08-07
Last updated
2026-10-16

Condition(s) studied

Primary Hyperaldosteronism

Investigational drug(s) / intervention(s)

Baxdrostat →Placebo

Baxdrostat: Baxdrostat tablet administered orally, once daily (QD).

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

Study 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 (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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Parent study 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. 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

Primary outcome measure(s)

  • Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8 — 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 — 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

Trial sites (76)

FacilityCityRegionStatus
Research Site San Francisco California
Research Site Farmington Connecticut
Research Site Springfield Illinois
Research Site Baltimore Maryland
Research Site Boston Massachusetts
Research Site Boston Massachusetts
Research Site Ann Arbor Michigan
Research Site Rochester Minnesota
Research Site Olive Branch Mississippi
Research Site Cleveland Ohio
Research Site Columbus Ohio
Research Site Bethlehem Pennsylvania
Research Site Philadelphia Pennsylvania
Research Site Columbia South Carolina
Research Site Dallas Texas
Research Site Brisbane Australia
Research Site Clayton Australia
Research Site Perth Australia
Research Site Calgary Alberta
Research Site Ottawa Ontario
Research Site Toronto Ontario
Research Site Montreal Quebec
Research Site Beijing China
Research Site Beijing China
Research Site Beijing China
Research Site Changsha China
Research Site Chengdu China
Research Site Chongqing China
Research Site Nanjing China
Research Site Shanghai China
Research Site Tianjin China
Research Site Wuhan China
Research Site Wuhan China
Research Site Amiens France
Research Site Bois-Guillaume France
Research Site Bordeaux France
Research Site Lille France
Research Site Paris France
Research Site Paris France
Research Site Berlin Germany

+ 36 more sites — see the full list on the official registry below.

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A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis. Recruiting
Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer Active, not recruiting
Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents Active, not recruiting
An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07007793 on ClinicalTrials.gov ↗ ← All trials in France