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This is a multicenter, randomized, double-blind, placebo-controlled phase II study designed to explore the efficacy and safety of different doses of SAL0140 in primary aldosteronism.
Participants diagnosed with primary aldosteronism were randomly assigned to the low-dose group, high-dose group or placebo group for a double-blind treatment period. Participants subsequently entered an open-label period to assess long-term efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose group | Experimental |
| |
| High-dose group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAL0140 Tablets | Drug | Drug: SAL0140 Tablets |
| |
| SAL0140 Tablets |
| Measure | Description | Time Frame |
|---|---|---|
| The baseline change in mean seated systolic blood pressure (msSBP) | Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment | at week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiqing Wang, PhD | Contact | 18917762201 | wqingw61@163.com | |
| Jiguang Wang, PhD | Contact | 13764189476 | jiguangw@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
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| Drug |
SAL0140 Tablets |
|
| SAL0140 placebo | Drug | Placebo |
|
| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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