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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.
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:
Participants will be randomized in a 2:1 ratio to one of 2 treatment arms:
Participants will receive either baxdrostat or placebo.
The overall study duration will be up to 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Baxdrostat 2 mg | Experimental | Participants will receive baxdrostat 2 mg tablet orally once daily. |
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| Arm 2: Placebo | Placebo Comparator | Participants will receive placebo tablet orally once daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baxdrostat | Drug | Baxdrostat will be administered orally once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serum Total Cortisol Level Before and After Adrenocorticotropic Hormone (ACTH) Stimulation Test | 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). | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Abnormal Stimulated Cortisol at Week 8 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85018 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| Redacted CSP | View source |
| Redacted SAP | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via there quest portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Participants who met all the inclusion and none of the exclusion criteria were enrolled in this study. All study assessments were performed as per the schedule of assessment.
This study was conducted in 10 sites in the United States of America from 10-June-2024 to 04-Dec-2024. The analyses presented in this report are based on a clinical data cutoff date of 28 January 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Baxdrostat 2 mg | Participants received a baxdrostat 2 mg tablet orally once daily. |
| FG001 | Placebo | Participants received placebo as a tablet orally once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 26, 2024 | Nov 14, 2025 |
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| Placebo | Drug | Placebo will be administered orally once daily. |
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| Week 8 |
| Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) | 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. | From Day 1 up to Week 8 or Safety follow-up (14 days post last dose), which ever comes first (up to 10 weeks) |
| Tempe |
| Arizona |
| 85281 |
| United States |
| Research Site | Montclair | California | 91763 | United States |
| Research Site | Tarzana | California | 91356 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Chicago | Illinois | 60643 | United States |
| Research Site | Metairie | Louisiana | 70006 | United States |
| Research Site | Houston | Texas | 77074 | United States |
| Research Site | Houston | Texas | 77099 | United States |
| Research Site | Norfolk | Virginia | 23502 | United States |
| Redacted CSR Synopsis | View source |
| COMPLETED |
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| NOT COMPLETED |
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The full analysis set included all randomized participants who received at least one dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baxdrostat 2 mg | Participants received a baxdrostat 2 mg tablet orally once daily. |
| BG001 | Placebo | Participants received placebo as a tablet orally once daily. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Incidence of Abnormal Stimulated Cortisol at Week 8 | 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. | The full analysis set included all randomized participants who received at least one dose of study intervention. Here, 'number of participants analyzed' and 'number analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | Count of Participants | Participants | Week 8 |
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| Secondary | Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) | 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. | The full analysis set included all randomized participants who received at least one dose of study intervention. | Posted | Count of Participants | 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) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Serum Total Cortisol Level Before and After Adrenocorticotropic Hormone (ACTH) Stimulation Test | 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). | The full analysis set included all randomized participants who received at least one dose of study intervention. Here, 'number of participants analyzed' and 'number analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | Count of Participants | Participants | Week 8 |
|
From Day 1 up to Week 8 or Safety follow-up (14 days post last dose), which ever comes first (up to 10 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baxdrostat 2 mg | Participants received a baxdrostat 2 mg tablet orally once daily. | 0 | 32 | 0 | 32 | 6 | 32 |
| EG001 | Placebo | Participants received placebo as a tablet orally once daily. | 0 | 16 | 0 | 16 | 6 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
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No unpublished information may be disclosed without prior written approval from AstraZeneca.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 9, 2024 | Nov 14, 2025 | SAP_003.pdf |
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| Male |
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| White |
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