Study identifier:D6970C00011
ClinicalTrials.gov identifier:NCT06336356
EudraCT identifier:N/A
CTIS identifier:N/A
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
Uncontrolled Hypertension
Phase 2
No
Baxdrostat, Placebo
All
48
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
-
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: • 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.
Location
Location
Tempe, AZ, United States, 85281
Location
Tampa, FL, United States, 33612
Location
Phoenix, AZ, United States, 85018
Location
Montclair, CA, United States, 91763
Location
Houston, TX, United States, 77074
Location
Tarzana, CA, United States, 91356
Location
Metairie, LA, United States, 70006
Location
Norfolk, VA, United States, 23502
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. |
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