A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulatio… (NCT06336356) | Clinical Trial Compass
CompletedPhase 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
United States48 participantsStarted 2024-06-10
Plain-language 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.
Who can participate
Age range18 Years – 130 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (\<) 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.
Exclusion Criteria:
* 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/…
What they're measuring
1
Number of Participants With Serum Total Cortisol Level Before and After Adrenocorticotropic Hormone (ACTH) Stimulation Test