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
NCT ID: NCT06336356
Last Updated: 2025-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2024-06-10
2024-12-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 2: Placebo
Participants will receive placebo tablet orally once daily.
Placebo
Placebo will be administered orally once daily.
Arm 1: Baxdrostat 2 mg
Participants will receive baxdrostat 2 mg tablet orally once daily.
Baxdrostat
Baxdrostat will be administered orally once daily.
Interventions
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Baxdrostat
Baxdrostat will be administered orally once daily.
Placebo
Placebo will be administered orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D6970C00011
Identifier Type: -
Identifier Source: org_study_id