Recruiting NCT07007793

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

Phase III Interventional Primary Hyperaldosteronism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Baxdrostat, Placebo.
Who it may be relevant to: Registry conditions: Primary Hyperaldosteronism. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Canada, China, France +7
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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]

Secondary outcome measures (6)

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]
Achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 21 centers

Research Site — Los Angeles
Research Site — San Francisco
Research Site — Farmington
Research Site — Chicago
Research Site — Springfield
Research Site — Baltimore
Research Site — Boston
Research Site — Boston
… and 13 more centers

China · 13 centers

Research Site — Beijing
Research Site — Beijing
Research Site — Beijing
Research Site — Changsha
Research Site — Chengdu
Research Site — Chengdu
Research Site — Chongqing
Research Site — Nanjing
… and 5 more centers

France · 7 centers

Research Site — Amiens
Research Site — Bois-Guillaume
Research Site — Bordeaux
Research Site — Lille
Research Site — Marseille
Research Site — Paris
Research Site — Paris

Japan · 7 centers

Research Site — Kawasaki-shi
Research Site — Kodaira-shi
Research Site — Minatoku
Research Site — Ōta-ku
Research Site — Shinjuku-ku
Research Site — Yokohama
Research Site — Yufu-shi

Germany · 6 centers

Research Site — Berlin
Research Site — Düsseldorf
Research Site — Kaiserslautern
Research Site — München
Research Site — Reinfeld (Holstein)
Research Site — Würzburg

India · 6 centers

Research Site — Belagavi
Research Site — Delhi
Research Site — Hyderabad
Research Site — Kolkata
Research Site — Mumbai
Research Site — Mumbai

Italy · 6 centers

Research Site — Bologna
Research Site — Brescia
Research Site — Florence
Research Site — Milan
Research Site — Milan
Research Site — Torino

Taiwan · 6 centers

Research Site — Kaohsiung City
Research Site — Taichung
… and 4 more centers

Spain · 5 centers

Research Site — Barcelona
Research Site — Madrid
Research Site — Madrid
Research Site — Madrid
Research Site — Seville

United Kingdom · 5 centers

Center list to be confirmed — check the primary protocol.

Canada · 4 centers

Research Site — Calgary
Research Site — Ottawa
Research Site — Toronto
Research Site — Montreal

Australia · 3 centers

Research Site — Brisbane
Research Site — Clayton
Research Site — Perth

Identifiers

NCT: NCT07007793 · D6974C00001

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗