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

Description

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 unsuppression of Plasma Renin Activity (PRA) in approximately 180 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 to based on clinical response and tolerability. The study is planned to be conducted globally in approximately 90 study centres and approximately 12 countries.

Conditions

Primary Hyperaldosteronism
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Related Conditions:

Primary Hyperaldosteronism

Study Overview

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Study Details

Study 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 unsuppression of Plasma Renin Activity (PRA) in approximately 180 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 to based on clinical response and tolerability. The study is planned to be conducted globally in approximately 90 study centres and approximately 12 countries.

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

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

Condition
Primary Hyperaldosteronism
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Research Site, Los Angeles, California, United States, 90048

San Francisco

Research Site, San Francisco, California, United States, 94110

Farmington

Research Site, Farmington, Connecticut, United States, 06030

Chicago

Research Site, Chicago, Illinois, United States, 60611

Springfield

Research Site, Springfield, Illinois, United States, 62702

Baltimore

Research Site, Baltimore, Maryland, United States, 21287

Boston

Research Site, Boston, Massachusetts, United States, 02111

Boston

Research Site, Boston, Massachusetts, United States, 02115

Ann Arbor

Research Site, Ann Arbor, Michigan, United States, 48109

Rochester

Research Site, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 orpotassium sparing diuretics per study requirement for participantstaking 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 Screeningdetermined 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.
  • * 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 2weeks prior to Randomisation.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2028-02-18