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
Study identifier:D6970C00011
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Will Be Recruiting
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
Medical condition
Uncontrolled Hypertension
Phase
Phase 2
Healthy volunteers
No
Study drug
Baxdrostat, Placebo
Sex
All
Estimated Enrollment
45
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 13 May 2024
Estimated Primary Completion Date: 05 Nov 2024
Estimated Study Completion Date: 05 Nov 2024
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1: Baxdrostat 2 mg Participants will receive baxdrostat 2 mg tablet orally once daily. | Drug: Baxdrostat Baxdrostat will be administered orally once daily. Other Name: RO6836191, Other Name: CIN-107 |
| Placebo Comparator: Arm 2: Placebo Participants will receive placebo tablet orally once daily. | Drug: Placebo Placebo will be administered orally once daily. |
