Phase 2
N=48
A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension
Uncontrolled Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT06336356 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Number of Participants With Serum Total Cortisol Level Before and After Adrenocorticotropic Hormone (ACTH) Stimulation Test — 0; 0; 26; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Baxdrostat (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serum Total Cortisol Level Before and After Adrenocorticotropic Hormone (ACTH) Stimulation Test |
0; 0; 26; 15 | — |
| SECONDARY Incidence of Abnormal Stimulated Cortisol at Week 8 |
0; 0; 26; 15 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) |
10; 6; 0; 0; 0; 0 | — |
Summary
The main purpose of this study is to assess the serum free cortisol response after ACTH stimulation test at baseline and at Week 8 in participants with uncontrolled hypertension.
Eligibility Criteria
Inclusion Criteria
- Participants with mean seated systolic blood pressure (SBP) on automated office blood pressure measurement (AOBPM) greater than equal to (>=) 130 millimeter of mercury (mmHg) and less than ( =130 mmHg and =1 antihypertensive medication (at least one should be a diuretic), for at least 4 weeks prior to screening.
- Participants must have an estimated glomerular filtration rate (eGFR) >=45 milliliter per minute (mL/min)/1.73-meter square (m^²) at screening.
- Participants must have a serum potassium+ (K+) level >=3.5 and =110 mmHg at randomization.
- Prior treatment (within the 4 weeks before screening) with angiotensin receptor Blocker (ARBs) and angiotensin converting enzyme inhibitor (ACEIs) (both taken simultaneously).
- Serum sodium (Na+) level 10.0% (86 mmol/mol) at screening.
- Fridericia's corrected QT (QTcF) value > 470 milliseconds (ms) at screening, unless having a pacemaker.
- Heart rate 110 beats/min in a resting position, as per vital signs assessment.
Data sourced from ClinicalTrials.gov (NCT06336356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.