This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
796
Baxdrostat tablet administered orally, once daily (QD). Unit dose strengths: * 1 mg per tablet for 1 mg baxdrostat Arm; * 2 mg per tablet for 2 mg baxdrostat Arm.
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Research Site
Saraland, Alabama, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Sun City West, Arizona, United States
Research Site
Surprise, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Change from baseline in seated systolic blood pressure for 2 mg baxdrostat
To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12
Time frame: At Week 12
Change from baseline in seated systolic blood pressure for 1 mg baxdrostat
To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12
Time frame: At Week 12
Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat
To assess the effect of 2 mg baxdrostat vs placebo on seated systolic blood pressure (SBP) at 8 weeks after randomised withdrawal
Time frame: At Week 32
Change from baseline in seated SBP for 2 mg baxdrostat
To assess the effect of 2 mg baxdrostat vs placebo on seated SBP at Week 12 in the resistant hypertension (rHTN) subpopulation
Time frame: At Week 12
Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat
To assess the effect of 2 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12
Time frame: At Week 12
Achieving seated SBP < 130 mmHg for 2 mg baxdrostat
To assess the effect of 2 mg baxdrostat vs placebo on achieving seated SBP \< 130 mmHg at Week 12
Time frame: At Week 12
Change from baseline in seated SBP for 1 mg baxdrostat
To assess the effect of 1 mg baxdrostat vs placebo on seated SBP at Week 12 in the rHTN subpopulation
Time frame: At Week 12
Change from baseline in seated DBP for 1 mg baxdrostat
To assess the effect of 1 mg baxdrostat vs placebo on seated DBP at Week 12
Time frame: At Week 12
Achieving seated SBP < 130 mmHg for 1 mg baxdrostat
To assess the effect of 1 mg baxdrostat vs placebo on achieving seated SBP \< 130 mmHg at Week 12
Time frame: At Week 12
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Fresno, California, United States
Research Site
Lincoln, California, United States
Research Site
Orange, California, United States
Research Site
Rancho Cucamonga, California, United States
Research Site
Stanford, California, United States
...and 253 more locations