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

Uncontrolled Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336356
• Other study ID #: D6970C00011
• Status: Recruiting
• Phase: Phase 2
• Start date: June 10, 2024
• Est. completion date: November 21, 2024

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 21, 2024
• Est. primary completion date: November 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Intervention

Drug:
• Baxdrostat
Baxdrostat will be administered orally once daily.
• Placebo
Placebo will be administered orally once daily.

Locations

Country	Name	City	State
United States	Research Site	Chicago	Illinois
United States	Research Site	Chula Vista	California
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Metairie	Louisiana
United States	Research Site	Montclair	California
United States	Research Site	Norfolk	Virginia
United States	Research Site	Phoenix	Arizona
United States	Research Site	Tampa	Florida
United States	Research Site	Tarzana	California
United States	Research Site	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual Cortisol Level	The serum free cortisol response before and after ACTH stimulation test will be evaluated.	At baseline and Week 8
Secondary	Number of Participants with Abnormal Stimulated Cortisol	Total abnormal serum cortisol response after ACTH stimulation test at Week 8 will be evaluated.	At Week 8