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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

NCT06336356

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: Uncontrolled Hypertension

Interventions: Baxdrostat, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 (\<) 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/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.

Locations (10)

Phoenix, Arizona, United States
Tempe, Arizona, United States
Montclair, California, United States
Tarzana, California, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Metairie, Louisiana, United States
Houston, Texas, United States
Houston, Texas, United States
Norfolk, Virginia, United States