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
Completed · Phase 2 · Has a placebo group
Conditions studied: Uncontrolled Hypertension
In brief
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.
Key facts
- Study ID
- NCT06336356
- Run by
- AstraZeneca
- People needed
- 48
- Starts
- 2024-06-10
- Expected to finish
- 2024-12-04
- Last updated by the study team
- 2025-12-17
Who can join
Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Mean seated diastolic blood pressure (DBP) on AOBPM >=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 < 135 millimole per liter (mmol/L) at screening, determined as per central laboratory.
- New York heart association functional heart failure (HF) Class IV at screening.
- Planned percutaneous coronary intervention/coronary artery bypass grafting or percutaneous coronary intervention/coronary artery bypass grafting done within 6 months prior to screening.
- 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.
- Heart rate < 45 or > 110 beats/min in a resting position, as per vital signs assessment.
Where it is running
- Research Site — Phoenix, Arizona, United States
- Research Site — Tempe, Arizona, United States
- Research Site — Montclair, California, United States
- Research Site — Tarzana, California, United States
- Research Site — Tampa, Florida, United States
- Research Site — Chicago, Illinois, United States
- Research Site — Metairie, Louisiana, United States
- Research Site — Houston, Texas, United States
- Research Site — Houston, Texas, United States
- Research Site — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.