Clinical trial • Phase III • Cardiology

BAXDROSTAT for Primary aldosteronism | Primary hyperaldosteronism

Phase III trial of BAXDROSTAT for Primary aldosteronism | Primary hyperaldosteronism.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Primary aldosteronism | Primary hyperaldosteronism
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
08-05-2025
First CTIS Authorization Date
14-08-2025

Trial design

Randomised, baxdrostat placebo (matching placebo). no dose or schedule specified for the placebo in the record.-controlled Phase III trial across 26 sites in Germany, Italy, France and others.

Randomised
Yes
Comparator
Baxdrostat Placebo (matching placebo). No dose or schedule specified for the placebo in the record.
Target Sample Size
131
Trial Duration For Participant
364

Eligibility

Recruits 131 No vulnerable populations selected (isVulnerablePopulationSelected:false). Participants must be ≥ 18 years of age. Subject information and informed consent forms for adults are provided (L1_SIS and ICF Adults and L1_SIS and ICF optional genomic documents present). No assent or paediatric consent described..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected:false). Participants must be ≥ 18 years of age. Subject information and informed consent forms for adults are provided (L1_SIS and ICF Adults and L1_SIS and ICF optional genomic documents present). No assent or paediatric consent described.

Inclusion criteria

  • {"criterion_text":"- Male or female participants must be ≥ 18 years of age\n- Participants with a documented diagnosis of PA that fulfils the criteria defined in the 2016 or 2025 Endocrine Society Guidelines.\n- 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.\n- eGFR ≥ 45 mL/min/1.73m2 at Screening\n- Serum potassium level ≥ 3.0 and < 5.0 mmol/L at Screening determined as per the central laboratory.\n- Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomisation\n- Mean seated SBP on AOBPM of ≥ 135 mmHg and ≤ 170 mmHg and mean DBP of ≤ 105 mmHg.\n- Serum potassium (local lab) > 3.0 mmol/L at randomization."}

Exclusion criteria

  • {"criterion_text":"- 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.\n- 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.\n- 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.\n- Serum sodium level < 135 mmol/L at Screening, determined as per central laboratory.\n- New York Heart Association functional HF class IV at Screening.\n- Persistent atrial fibrillation.\n- Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomisation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Change from baseline in seated SBP at Week 8","definition_or_measurement_approach":"Change from baseline in seated systolic blood pressure (seated SBP) measured at Week 8."}
  • {"endpoint_text":"- 2. Normalization of the Renin Angiotensin Aldosterone system (RAAS) at Week 8","definition_or_measurement_approach":"Achievement of normalization of the Renin Angiotensin Aldosterone System (RAAS) at Week 8 (definition/assay not further specified in record)."}

Secondary endpoints

  • {"endpoint_text":"- Percent change from RWD baseline (Week 44) in DRC at Week 52","definition_or_measurement_approach":"Percent change from randomized withdrawal (RWD) baseline (Week 44) in direct renin concentration (DRC) measured at Week 52."}
  • {"endpoint_text":"- Change from RWD baseline (Week 44) in seated SBP at Week 52","definition_or_measurement_approach":"Change from RWD baseline (Week 44) in seated systolic blood pressure measured at Week 52."}
  • {"endpoint_text":"- Achieving normalisation of the Renin Angiotensin Aldosterone System (RAAS) at week 8","definition_or_measurement_approach":"Achievement of RAAS normalization at Week 8 in participants; specific assays/thresholds not detailed in record."}
  • {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion of participants achieving serum potassium ≥ 3.7 mmol/L without potassium supplementation at Week 8 (central/local lab criteria referenced elsewhere)."}
  • {"endpoint_text":"- Achieving 24-hour urine aldosterone < 10 μg at Week 8 in participants with 24-hour urine aldosterone ≥ 10 μg at baseline","definition_or_measurement_approach":"Achievement of 24-hour urine aldosterone < 10 µg at Week 8 in participants with elevated baseline 24-hour urine aldosterone."}
  • {"endpoint_text":"- Percent change from baseline in 24-hour urine albumin at Week 8","definition_or_measurement_approach":"Percent change from baseline in 24-hour urine albumin measured at Week 8."}

Recruitment

Planned Sample Size
131
Recruitment Window Months
30
Consent Approach
Informed consent obtained from adult participants (participants ≥ 18 years). Subject information and informed consent forms for adults and an optional genomic consent are provided (documents: L1_SIS and ICF Adults; L1_SIS and ICF Genomics/optional genomic). Protocol and synopses have translations in English, Spanish, French and Italian indicating materials available in these languages.

Methods

  • K1_Recruitment arrangements (document available) - recruitment arrangements file present.
  • K2_Recruitment material Poster (document available) - poster recruitment material present.
  • K2_Recruitment material Pamphlet (document available) - pamphlet recruitment material present.
  • K2_Recruitment material Animation (document available) - animation recruitment material present.
  • K2_Recruitment material general advertisement (document available) - general advertisement material present.

Geography

Total Number Of Sites
26
Total Number Of Participants
49

Germany

Earliest CTIS Part Ii Submission Date
20-06-2025
Latest Decision Or Authorization Date
14-08-2025
Processing Time Days
55
Number Of Sites
7
Number Of Participants
13

Sites

Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Nephrologie
Contact Person Name
Johannes Stegbauer
Site Name
Kardiopraxis Schirmer
Contact Person Name
Stephan Schirmer
Site Name
Praxis Reinfeld Mitte
Contact Person Name
Joachim Weimer
Contact Person Email
dr.joachimweimer@t-online.de
Site Name
LMU Klinikum Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik IV Conn/Cushing-Ambulanz, Campus Innenstadt
Contact Person Name
Nicole Reisch
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik für Nephrologie
Contact Person Name
Markus van der Giet
Contact Person Email
markus.vandergiet@charite.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Klinik und Poliklinik I
Contact Person Name
Carmina Teresa Fuss
Contact Person Email
Fuss_C@ukw.de
Site Name
Praxis (other) listed

Italy

Earliest CTIS Part Ii Submission Date
28-05-2025
Latest Decision Or Authorization Date
21-08-2025
Processing Time Days
85
Number Of Sites
6
Number Of Participants
9

Sites

Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Contact Person Name
Maria Lorenza Muiesan
Contact Person Email
marialorenza.muiesan@unibs.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Cardiology IV
Contact Person Name
Alessandro Maloberti
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SOD di Endocrinologia
Contact Person Name
Letizia Canu
Contact Person Email
letizia.canu@unifi.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
SCU Medicina Interna 4 – Centro Ipertensione Arteriosa
Contact Person Name
Paolo Mulatero
Contact Person Email
paolo.mulatero@unito.it
Site Name
Istituto Auxologico Italiano
Department Name
Cardiology
Contact Person Name
Grzegorz Bilo
Contact Person Email
g.bilo@auxologico.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Division of Endocrinology and Diabetes Prevention and care
Contact Person Name
Guido Di Dalmazi
Contact Person Email
guido.didalmazi@unibo.it

France

Earliest CTIS Part Ii Submission Date
23-06-2025
Latest Decision Or Authorization Date
14-08-2025
Processing Time Days
52
Number Of Sites
7
Number Of Participants
12

Sites

Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Endocrinlogie, Diabetologie, Oncologie endocrinienne, Métabolisme
Contact Person Name
Stéphanie ESPIARD
Contact Person Email
stephanie.espiard@chu-lille.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hypertension artérielle
Contact Person Name
Julien DOUBLET
Contact Person Email
julien.doublet@chu-bordeaux.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Physiologie, hypertension clinique
Contact Person Name
Emmanuelle VIDAL-PETIOT
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Endocrinologie, Diabétologie et Maladies métaboliques
Contact Person Name
Antoine-Guy LOPEZ
Contact Person Email
Antoine-guy.lopez@chu-rouen.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Service d’endocrinologie
Contact Person Name
Abdallah AL-SALAMEH
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hypertension
Contact Person Name
Laurence AMAR
Contact Person Email
laurence.amar@aphp.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Médecine vasculaire et Hypertension
Contact Person Name
Gabrielle SARLON-BARTOLI
Contact Person Email
gabrielle.sarlon@ap-hm.fr

Spain

Earliest CTIS Part Ii Submission Date
04-07-2025
Latest Decision Or Authorization Date
19-08-2025
Processing Time Days
46
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
Hospital Clinico San Carlos
Department Name
Endocrinology
Contact Person Name
Mario Pazos Guerra
Contact Person Email
mar.pazos@salud.madrid.org
Site Name
Hospital Clinic De Barcelona
Department Name
Endocrinology
Contact Person Name
Felicia Alexandra Hanzu
Contact Person Email
fhanzu@clinic.cat
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Endocrinology
Contact Person Name
Miguel Ángel Mangas Cruz
Site Name
Hospital Universitario La Paz
Department Name
Endocrinology
Contact Person Name
Paola Parra Ramírez
Contact Person Email
paola.parra@salud.madrid.org
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Endocrinology
Contact Person Name
Jorge Gabriel Ruiz Sánchez
Contact Person Email
jorgeg.ruiz@quironsalud.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Endocrinology
Contact Person Name
Marta Araujo Castro
Contact Person Email
marta.araujo@madrid.salud.org

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
Baxdrostat
Active Substance
BAXDROSTAT
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
prodAuthStatus 1
Dose Levels
Max daily dose 2 mg; max total dose 728 mg; max treatment period 52 weeks
Maximum Dose
2 mg daily (maxDailyDoseAmount 2)
Investigational Product Name
Baxdrostat
Active Substance
BAXDROSTAT
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
prodAuthStatus 1
Dose Levels
Max daily dose 4 mg; max total dose 1400 mg; max treatment period 50 weeks
Maximum Dose
4 mg daily (maxDailyDoseAmount 4)
Investigational Product Name
Baxdrostat Placebo
Modality
Other

Related trials

Other published trials that may interest you.