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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT06336356•AstraZeneca

View on ClinicalTrials.gov

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

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

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)

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

Key Dates

Start Date

June 10, 2024

Primary Completion Date

December 4, 2024

Completion Date

December 4, 2024

Last Updated

December 17, 2025

Enrollment

ACTUAL participants

Conditions

Uncontrolled Hypertension

Interventions

Baxdrostat

DRUG

Placebo

DRUG

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Chronic Kidney Disease(CKD)Uncontrolled Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease

A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension

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