Clinical trial NCT06336356: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uncontrolled Hypertension
Keywords: Adrenocorticotropic hormone stimulation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-03-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a placebo-controlled study to evaluate cortisol reserve after ACTH stimulation test following treatment with 2 milligrams (mg) baxdrostat versus placebo.

The study consists of 3 period:

* 4-week screening period.
* An 8-week double-blind treatment period.
* A safety follow-up 2 weeks after last dose.

Participants will be randomized in a 2:1 ratio to one of 2 treatment arms:

1. Baxdrostat
2. Placebo

Participants will receive either baxdrostat or placebo.

The overall study duration will be up to 16 weeks.

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.

Primary outcomes:
measure: Individual Cortisol Level
timeFrame: At baseline and Week 8
Secondary outcomes:
measure: Number of Participants with Abnormal Stimulated Cortisol
timeFrame: At Week 8
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tempe
country: United States
facility: Research Site
state: Arizona
city: Montclair
country: United States
facility: Research Site
state: California
city: Tarzana
country: United States
facility: Research Site
state: California
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Metairie
country: United States
facility: Research Site
state: Louisiana
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Norfolk
country: United States
facility: Research Site
state: Virginia
Study officials:
References: