Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT06336356
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2024-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
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
Sponsor:
AstraZeneca
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: