About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, aged ≥ 18 years on the date of signing the informed consent form.
Diagnosed with primary aldosteronism.
Not having taken antihypertensive medication prior to randomization, or having been on a stable antihypertensive regimen .
Voluntarily sign the informed consent form before the trial, fully understand the trial content, procedures, and possible adverse reactions, and be capable and willing to comply with the protocol requirements to complete the study.
Disqualifiers
Has known secondary causes of hypertension.
Has previously undergone, or plans to undergo during the study period, adrenal-related surgeries, including adrenalectomy, adrenal ablation, etc.
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².
Has had any malignancy of an organ system within 5 years before screening.
Trial design
Parallel
Treatments tested in this trial
HRS-1780 Tablets
DrugHRS-1780 Tablets
Placebo
DrugPlacebo
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in office systolic blood pressure (SBP);
Secondary outcomes
Rate of achieving office blood pressure <140/90 mmHg;
Rate of achieving office blood pressure <130/80 mmHg;
Change from baseline in office diastolic blood pressure (DBP) ;
Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean SBP and DBP ;
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: