Skip to content

Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT06336356 (opens ClinicalTrials.gov in a new tab)Other idD6970C00011
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures ACTH (corticotropin), does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase 2
Enrollment
48 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
10 Jun 2024
Primary completion
4 Dec 2024
Completion
4 Dec 2024
First posted
28 Mar 2024
Last update posted
17 Dec 2025
Conditions
Uncontrolled Hypertension

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242025
  1. Ph 2

    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

    10 Jun 2024 to 4 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • BaxdrostatDrug
  • PlaceboDrug

Arms2

  • Experimental

    Arm 1: Baxdrostat 2 mg

    Participants will receive baxdrostat 2 mg tablet orally once daily.

  • Placebo comparator

    Arm 2: Placebo

    Participants will receive placebo tablet orally once daily.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Serum Total Cortisol Level Before and After Adrenocorticotropic Hormone (ACTH) Stimulation Test

    Time frame · Week 8

    Registry description

    The primary endpoint is individual participant's cortisol levels at each timepoint. Number of participants with normal stimulated serum total cortisol level at baseline are presented here. Characterisation of the serum total cortisol levels before and after ACTH stimulation test. An ACTH stimulation test using 250 μg ACTH was performed at baseline and Week 8 (End of Treatment), with serum cortisol level measured before and after ACTH stimulation test. Normal cortisol levels are defined as at least 18 μg/dL when measured 60 minutes (±10 minutes) after stimulation. If the Week 8 results show abnormal levels, a repeat test is conducted. In this repeat test, cortisol is considered abnormal only if both of the following conditions are met: the level is less than 14.8 μg/dL at 30 minutes (± 5 minutes) and less than 18 μg/dL at 60 minutes (±10 minutes).

Secondary outcomes(2)

  1. Incidence of Abnormal Stimulated Cortisol at Week 8

    Time frame · Week 8

    Registry description

    The secondary endpoint is the incidence of abnormal stimulated cortisol after ACTH stimulation test at Week 8. Incidence of normal stimulated serum total cortisol level at baseline are presented. Normal cortisol levels are defined as at least 18 μg/dL when measured 60 minutes (±10 minutes) after stimulation. If the Week 8 results show abnormal levels, a repeat test is conducted. In this repeat test, cortisol is considered abnormal only if both of the following conditions are met: the level is less than 14.8 μg/dL at 30 minutes (± 5 minutes) and less than 18 μg/dL at 60 minutes (±10 minutes). Participants who had abnormal cortisol levels at the start of the study (baseline) were not included in this analysis.

  2. Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)

    Time frame · From Day 1 up to Week 8 or Safety follow-up (14 days post last dose), which ever comes first (up to 10 weeks)

    Registry description

    Safety and tolerability of baxdrostat as compared with placebo was assessed. For this clinical study, AESIs include the following: hyperkalaemia, hyponatraemia and hypotension events that require medical intervention.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Week 8

Number of Participants With Serum Total Cortisol Level Before and After Adrenocorticotropic Hormone (ACTH) Stimulation Test

GroupValue (Participants)
Baxdrostat 2 mg0
Placebo0
Secondary and other outcome results(2)
Secondary outcomeCount of participants· Week 8

Incidence of Abnormal Stimulated Cortisol at Week 8

GroupValue (Participants)
Baxdrostat 2 mg0
Placebo0
Secondary outcomeCount of participants· From Day 1 up to Week 8 or Safety follow-up (14 days post last dose), which ever comes first (up to 10 weeks)

Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)

GroupValue (Participants)
Baxdrostat 2 mg10
Placebo6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Baxdrostat 2 mgParticipants received a baxdrostat 2 mg tablet orally once daily.0 / 320 / 326 / 32
PlaceboParticipants received placebo as a tablet orally once daily.0 / 160 / 166 / 16

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 130 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.