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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
HRS-1780 Tablets
Placebo
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGChange from baseline in office systolic blood pressure (SBP);
Time frame: up to Week 8
Rate of achieving office blood pressure <140/90 mmHg;
Time frame: up to Week 8
Rate of achieving office blood pressure <130/80 mmHg;
Time frame: up to Week 8
Change from baseline in office diastolic blood pressure (DBP) ;
Time frame: up to Week 8
Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean SBP and DBP ;
Time frame: up to Week 8
Change from baseline in 24-hour ABPM daytime and nighttime SBP and DBP ;
Time frame: up to Week 8
Change from baseline in serum potassium (K+) and serum sodium ;
Time frame: Weeks 2, 4, and 8
Total cumulative dose of potassium supplement (potassium chloride) ;
Time frame: up to Week 8
Proportion of participants with a ≥30% decline in estimated glomerular filtration rate (eGFR);
Time frame: up to Week 8
Proportion of participants with 5.5 < K+ ≤ 6.0 mmol/L;
Time frame: up to Week 8
Proportion of participants with K+ > 6.0 mmol/L;
Time frame: up to Week 8
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