NCT06336356CompletedPhase 2
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
A Randomised, Double-blind, Placebo-controlled Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone Stimulation Test Following Treatment With Baxdrostat for 8 Weeks in Participants With Uncontrolled Hypertension
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 22 Mar 2024
- Start date
- 10 Jun 2024
- Primary completion date
- 4 Dec 2024
- Lead sponsor
- AstraZeneca
- Diseases
- High blood pressure
- NCT number
- NCT06336356
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 48
- From 10 Jun 2024 to the primary completion date, 4 Dec 2024
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment (within the 4 weeks before screening) with angiotensin receptor Blocker (ARBs) and angiotensin converting enzyme inhibitor (ACEIs) (both taken simultaneously).
- Planned percutaneous coronary intervention/coronary artery bypass grafting or percutaneous coronary intervention/coronary artery bypass grafting done within 6 months prior to screening.
Other illness
- New York heart association functional heart failure (HF) Class IV at screening.
- Heart rate \< 45 or \> 110 beats/min in a resting position, as per vital signs assessment.
Lab values
- Serum sodium (Na+) level \< 135 millimole per liter (mmol/L) at screening, determined as per central laboratory.
- Uncontrolled diabetes with glycated haemoglobin (HbA1c) \> 10.0% (86 mmol/mol) at screening.
- Fridericia's corrected QT (QTcF) value \> 470 milliseconds (ms) at screening, unless having a pacemaker.
Other
- Mean seated diastolic blood pressure (DBP) on AOBPM \>=110 mmHg at randomization.
Who the study is looking for
- 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 (\<) 170 mmHg at screening.
- Participants with mean seated SBP on AOBPM of \>=130 mmHg and \< 170 mmHg at randomization.
- Participants must have a stable regimen of \>=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 \< 5.0 millimole per liter (mmol/L) at screening.
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Metairie | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Montclair | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Tarzana | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Tempe | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.