This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).
This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg baxdrostat versus placebo, administered once a day (QD) orally, on the reduction of ambulatory SBP in participants with rHTN, defined as BP targets not being achieved in an individual despite the use of at least 3 antihypertensive agents of different classes (at maximum tolerated dose in the judgement of the Investigator), one of which is a diuretic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
218
Baxdrostat tablet administered orally, once daily (QD). Unit dose strength: • 2 mg per tablet.
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Least Square Mean Difference for Change From Baseline in Ambulatory 24-hour Average SBP at Week 12: Treatment Policy Strategy
Time frame: Baseline to week 12
Change From Baseline in Ambulatory Night-time Average SBP (mmHg) at Week 12 LS Means
Time frame: Baseline to week 12
Change From Baseline in Ambulatory Daytime Average SBP (mmHg) at Week 12
Time frame: Baseline to week 12
Change From Baseline in Seated SBP (mmHg) at Week 12
Time frame: Baseline to week 12
Achieving Ambulatory 24-hour Average SBP of < 130 mmHg at Week 12
Time frame: Baseline to week 12
Change From Baseline in Ambulatory 24-hour Average DBP (mmHg) at Week 12
Time frame: Baseline to week 12
Change From Baseline in Ambulatory Night-time Average DBP (mmHg) at Week 12
Time frame: Baseline to week 12
Change From Baseline in Ambulatory Daytime Average DBP (mmHg) at Week 12
Time frame: Baseline to week 12
Change From Baseline in Seated DBP (mmHg) at Week 12
Time frame: Baseline to week 12
Achieving a Nocturnal SBP Dipping of >= 10% at Week 12
Time frame: Baseline to week 12
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Research Site
Surprise, Arizona, United States
Research Site
Hollywood, Florida, United States
Research Site
Lake Worth, Florida, United States
Research Site
Port Charlotte, Florida, United States
Research Site
Fort Wayne, Indiana, United States
Research Site
Lexington, Kentucky, United States
Research Site
The Bronx, New York, United States
Research Site
Greenville, North Carolina, United States
Research Site
Jacksonville, North Carolina, United States
Research Site
Kinston, North Carolina, United States
...and 92 more locations