NCT06336356

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uncontrolled Hypertension

Interventions

Type	Name	Description
DRUG	Baxdrostat	Baxdrostat will be administered orally once daily.
DRUG	Placebo	Placebo will be administered orally once daily.

Timeline

• Start date: 2024-06-10
• Primary completion: 2024-12-04
• Completion: 2024-12-04
• First posted: 2024-03-28
• Last updated: 2025-12-17
• Results posted: 2025-12-17

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study