Primary Aldosteronism defined by excess aldosterone secretion
Conditions
Brief summary
1. Change from baseline in seated SBP at Week 8, 2. Achieving xxx at Week 8 in participants xxx at baseline
Detailed description
Change from RWD baseline (Week 44) in seated SBP at Week 52, Percent change from RWD baseline (Week 44) in PRA at Week 52, 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, Percent change from baseline in PRA at Week 8, Achieving 24-hour urine aldosterone < 10 μg at Week 8 in participants with 24-hour urine aldosterone ≥ 10 μg at baseline, Change from baseline in 24-hour urine albumin at Week 8
Interventions
DRUGBaxdrostat
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in seated SBP at Week 8, 2. Achieving xxx at Week 8 in participants xxx at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from RWD baseline (Week 44) in seated SBP at Week 52, Percent change from RWD baseline (Week 44) in PRA at Week 52, 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, Percent change from baseline in PRA at Week 8, Achieving 24-hour urine aldosterone < 10 μg at Week 8 in participants with 24-hour urine aldosterone ≥ 10 μg at baseline, Change from baseline in 24-hour urine albumin at Week 8 | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed