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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Baxdrostat will be administered orally once daily.
Placebo will be administered orally once daily.
Research Site
Phoenix, Arizona, United States
Research Site
Tempe, Arizona, United States
Research Site
Montclair, California, United States
Research Site
Tarzana, California, United States
Number of Participants With Serum Total Cortisol Level Before and After Adrenocorticotropic Hormone (ACTH) Stimulation Test
The primary endpoint is individual participant's cortisol levels at each timepoint. Number of participants with normal stimulated serum total cortisol level at baseline are presented here. Characterisation of the serum total cortisol levels before and after ACTH stimulation test. An ACTH stimulation test using 250 μg ACTH was performed at baseline and Week 8 (End of Treatment), with serum cortisol level measured before and after ACTH stimulation test. Normal cortisol levels are defined as at least 18 μg/dL when measured 60 minutes (±10 minutes) after stimulation. If the Week 8 results show abnormal levels, a repeat test is conducted. In this repeat test, cortisol is considered abnormal only if both of the following conditions are met: the level is less than 14.8 μg/dL at 30 minutes (± 5 minutes) and less than 18 μg/dL at 60 minutes (±10 minutes).
Time frame: Week 8
Incidence of Abnormal Stimulated Cortisol at Week 8
The secondary endpoint is the incidence of abnormal stimulated cortisol after ACTH stimulation test at Week 8. Incidence of normal stimulated serum total cortisol level at baseline are presented. Normal cortisol levels are defined as at least 18 μg/dL when measured 60 minutes (±10 minutes) after stimulation. If the Week 8 results show abnormal levels, a repeat test is conducted. In this repeat test, cortisol is considered abnormal only if both of the following conditions are met: the level is less than 14.8 μg/dL at 30 minutes (± 5 minutes) and less than 18 μg/dL at 60 minutes (±10 minutes). Participants who had abnormal cortisol levels at the start of the study (baseline) were not included in this analysis.
Time frame: Week 8
Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
Safety and tolerability of baxdrostat as compared with placebo was assessed. For this clinical study, AESIs include the following: hyperkalaemia, hyponatraemia and hypotension events that require medical intervention.
Time frame: From Day 1 up to Week 8 or Safety follow-up (14 days post last dose), which ever comes first (up to 10 weeks)
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Research Site
Tampa, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Metairie, Louisiana, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Norfolk, Virginia, United States