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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AstraZeneca
Study ID
NCT06336356
Phase
PHASE2
Status
Completed

Conditions

  • Uncontrolled Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Baxdrostat — DRUG
    Baxdrostat will be administered orally once daily.
  • Placebo — DRUG
    Placebo will be administered orally once daily.

Study Details

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.

Key Dates

Start date
Jun 10, 2024
Status verified
Dec 2025
Primary completion
Dec 4, 2024
Completion
Dec 4, 2024

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Baxdrostat 2 mg
    Participants will receive baxdrostat 2 mg tablet orally once daily.
  • Placebo Comparator: Arm 2: Placebo
    Participants will receive placebo tablet orally once daily.

Primary Outcome Measure

Number of Participants With Serum Total Cortisol Level Before and After Adrenocorticotropic Hormone (ACTH) Stimulation Test [ Time Frame: Week 8 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85018-
Research SiteTempeArizona85281-
Research SiteMontclairCalifornia91763-
Research SiteTarzanaCalifornia91356-
Research SiteTampaFlorida33612-
Research SiteChicagoIllinois60643-
Research SiteMetairieLouisiana70006-
Research SiteHoustonTexas77074-
Research SiteHoustonTexas77099-
Research SiteNorfolkVirginia23502-

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