RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) 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 based on clinical response and tolerability. The study is planned to be conducted globally in approximately 90 study centres and 12 countries.

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

Quick Facts

Study Start:2025-08-07
Study Completion:2028-02-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07007793

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female participants must be ≥ 18 years of age
  2. * Participants with a documented diagnosis of PA that fulfils the criteria defined in the 2016 or 2025 Endocrine Society Guidelines.
  3. * 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.
  4. * eGFR ≥ 45 mL/min/1.73m2 at Screening
  5. * Serum potassium level ≥ 3.0 and \< 5.0 mmol/L at Screening determined as per the central laboratory.
  6. * Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomisation
  7. * Mean seated SBP on AOBPM of ≥ 135 mmHg and ≤ 170 mmHg and mean DBP of
  8. * Serum potassium (local lab) \> 3.0 mmol/L at randomization.
  1. * 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.
  2. * 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.
  3. * Serum sodium level \< 135 mmol/L at Screening, determined as per central laboratory.
  4. * New York Heart Association functional HF class IV at Screening.
  5. * Persistent atrial fibrillation.
  6. * Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomisation.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Los Angeles, California, 90048
United States
Research Site
San Francisco, California, 94110
United States
Research Site
Farmington, Connecticut, 06030
United States
Research Site
Chicago, Illinois, 60611
United States
Research Site
Springfield, Illinois, 62702
United States
Research Site
Baltimore, Maryland, 21287
United States
Research Site
Boston, Massachusetts, 02111
United States
Research Site
Boston, Massachusetts, 02115
United States
Research Site
Ann Arbor, Michigan, 48109
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
Olive Branch, Mississippi, 38654
United States
Research Site
Kansas City, Missouri, 64151
United States
Research Site
New York, New York, 10065
United States
Research Site
Cleveland, Ohio, 44195
United States
Research Site
Columbus, Ohio, 43203
United States
Research Site
Bethlehem, Pennsylvania, 18017
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Columbia, South Carolina, 29203
United States
Research Site
Brownsville, Texas, 78526
United States
Research Site
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-07
Study Completion Date2028-02-18

Study Record Updates

Study Start Date2025-08-07
Study Completion Date2028-02-18

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Primary Hyperaldosteronism