This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of baxdrostat versus placebo, on the reduction of Seated Blood Pressure (SBP) and achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) in approximately 250 participants ≥ 18 years of age with Primary Aldosteronism (PA), with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics. Baxdrostat (or placebo) will be administered once daily, up-titrated after 2 weeks based on clinical response and tolerability. The study is planned to be conducted globally in approximately 90 study centres and 12 countries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
Baxdrostat tablet administered orally, once daily (QD).
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Research Site
Los Angeles, California, United States
WITHDRAWNResearch Site
San Francisco, California, United States
ACTIVE_NOT_RECRUITINGResearch Site
Farmington, Connecticut, United States
ACTIVE_NOT_RECRUITINGResearch Site
Chicago, Illinois, United States
RECRUITINGChange from baseline in seated Systolic Blood Pressure (SBP) at Week 8
To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) at Week 8
Time frame: At week 8
Achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) at week 8.
To assess the effect of baxdrostat vs placebo on achieving normalization of renin at week 8
Time frame: At week 8
Percent change from RWD baseline (Week 44) in Direct Renin Concentration (DRC) at Week 52
To assess the effect of baxdrostat versus placebo on the percent change in DRC 8 weeks after the start of RWD
Time frame: At week 52
Change from Randomised withdrawal (RWD) baseline (Week 44) in seated Systolic Blood Pressure (SBP) at Week 52
To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) 8 weeks after the start of Randomised withdrawal (RWD)
Time frame: At week 52
Achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) at week 8.
To assess the effect of baxdrostat vs placebo on achieving normalization of renin at week 8, in participants with dysregulated RAAS at baseline.
Time frame: At week 8
Achieving serum potassium ≥ 3.7 mmol/L without potassium supplementation at Week 8 in participants with serum potassium < 3.7 mmol/L or potassium supplementation at baseline
To assess the effect of baxdrostat versus placebo on achieving serum potassium ≥ 3.7 mmol/L without potassium supplementation at Week 8 in participants with serum potassium \< 3.7 mmol/L or potassium supplementation at baseline
Time frame: At week 8
Achieving 24-hour urine aldosterone < 10 μg at Week 8 in participants with 24-hour urine aldosterone ≥ 10 μg at baseline
To assess the effect of baxdrostat versus placebo on achieving 24-hour urine aldosterone \< 10 μg at Week 8 in participants with 24-hour urine aldosterone ≥ 10 μg at baseline
Time frame: At week 8
Percent change from baseline in 24-hour urine albumin at Week 8
To assess the effect of baxdrostat versus placebo on 24-hour urine albumin at Week 8
Time frame: At week 8
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Research Site
Springfield, Illinois, United States
ACTIVE_NOT_RECRUITINGResearch Site
Baltimore, Maryland, United States
ACTIVE_NOT_RECRUITINGResearch Site
Boston, Massachusetts, United States
ACTIVE_NOT_RECRUITINGResearch Site
Boston, Massachusetts, United States
ACTIVE_NOT_RECRUITINGResearch Site
Ann Arbor, Michigan, United States
ACTIVE_NOT_RECRUITINGResearch Site
Rochester, Minnesota, United States
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