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A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study Evaluating the Efficacy and Safety of HRS-1780 in Adults With Primary Aldosteronism
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-04-30
60
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of HRS-1780 in adults diagnosed with primary aldosteronism. The study aims to compare HRS-1780 against a placebo in 60 participants to better understand its effects on blood pressure and related health measures. Participants will be randomly assigned to receive either HRS-1780 tablets or a placebo. The treatment period lasts up to 8 weeks, during which changes in systolic and diastolic blood pressure, both in the office and via 24-hour ambulatory monitoring, will be assessed. The study also monitors serum potassium and sodium levels, potassium supplementation needs, and kidney function during this time. During the trial, participants will undergo regular blood pressure measurements, laboratory tests for electrolytes and kidney function at weeks 2, 4, and 8, and monitoring of any adverse effects. The primary measure is the change from baseline in office systolic blood pressure by week 8. Safety and efficacy will be closely followed throughout the study, which is scheduled to complete by November 2026.
CONDITIONS
Brief Title
A Phase II Clinical Study on the Efficacy and Safety of HRS-1780 in Participants With Primary Aldosteronism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at the time of signing informed consent
- Diagnosed with primary aldosteronism
- No use of antihypertensive drugs before screening, or stable use of antihypertensive drugs
- Voluntarily sign informed consent and willing to comply with study procedures
- Willing to use highly effective contraception from consent signing until 4 weeks after last dose
You will not qualify if you...
- Known secondary causes of hypertension
- Previous or planned adrenal-related surgeries during the study period
- Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m²
- Malignancy within 5 years before screening
- Use of other investigational drugs within 90 days or 5 half-lives before screening
- Blood donation or loss of ≥400 mL within 3 months, or blood transfusion within 2 months before screening
- Known or suspected alcohol or narcotic abuse
- Pregnant, breastfeeding, planning pregnancy, or unable to use effective contraception
- Abnormal daily routine
- Use of strong CYP3A4 inhibitors/inducers within 1 week before randomization
- Severe infection, trauma, or major surgery within 1 month before screening
- Recent serious cardiovascular events within 3 months before screening
- Clinically significant diseases interfering with trial or posing risks
- Severe mental disorders or incapacity preventing participation
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times upper normal limit
- Any condition affecting participant safety or trial evaluation according to investigator judgment
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 8 weeks
Participants receive HRS-1780 tablets or placebo to evaluate the efficacy and safety in managing primary aldosteronism.
Visits at Weeks 2, 4, and 8 for assessments including blood pressure and blood tests
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
2
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
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Research Team
S
Shenhuan Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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