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This study is a multicenter, randomized, double-blind, placebo-parallel-controlled phase II clinical trial to evaluate the efficacy and safety of HRS-1780 compared with placebo in participants with primary aldosteronism. The study plans to enroll 60 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-1780 Tablets | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1780 Tablets | Drug | HRS-1780 Tablets |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in office systolic blood pressure (SBP); | up to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of achieving office blood pressure <140/90 mmHg; | up to Week 8 | |
| Rate of achieving office blood pressure <130/80 mmHg; | up to Week 8 | |
| Change from baseline in office diastolic blood pressure (DBP) ; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shenhuan Liu | Contact | 0518-82342973 | shenhuan.liu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400016 | China |
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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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| Drug |
Placebo |
|
| up to Week 8 |
| Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean SBP and DBP ; | up to Week 8 |
| Change from baseline in 24-hour ABPM daytime and nighttime SBP and DBP ; | up to Week 8 |
| Change from baseline in serum potassium (K+) and serum sodium ; | Weeks 2, 4, and 8 |
| Total cumulative dose of potassium supplement (potassium chloride) ; | up to Week 8 |
| Proportion of participants with a ≥30% decline in estimated glomerular filtration rate (eGFR); | up to Week 8 |
| Proportion of participants with 5.5 < K+ ≤ 6.0 mmol/L; | up to Week 8 |
| Proportion of participants with K+ > 6.0 mmol/L; | up to Week 8 |
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
|