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This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of QLS1410 versus placebo, on the reduction of Seated Blood Pressure (SBP) in participants ≥ 18 years of age with Primary Aldosteronism (PA) with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics.
QLS1410 (or placebo) will be administered once daily, up-titrated after 2 weeks or 4 weeks based on clinical response and tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS1410 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS1410 | Drug | QLS1410 tablet administered orally, once daily (QD). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in seated Systolic Blood Pressure (SBP) at Week 12 | To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) at Week 12 | at week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Liu | Contact | +86-18322017516 | mingliu@tmu.edu.cn |
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| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| Placebo |
| Drug |
Placebo tablet administered orally, once daily (QD). |
|