RecruitingPhase 2NCT07021963
A Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy
A Multicenter, Open-label Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy
Sponsor
Shandong Suncadia Medicine Co., Ltd.
Enrollment
300 participants
Start Date
Jul 4, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This study mainly evaluates the long-term safety of HRS-1893 in subjects with hypertrophic cardiomyopathy.
Eligibility
Min Age: 18 YearsMax Age: 85 Years
Inclusion Criteria3
- Subjects with hypertrophic cardiomyopathy who have previously completed HRS-1893 related studies.
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and must be non-lactating during the study. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time they sign the informed consent form until 3 months after the last dose of trial drug, and to comply with relevant contraceptive requirements.
- Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
Exclusion Criteria4
- Previous history of coronary artery disease (stenosis of one or more coronary arteries >70%) or myocardial infarction.
- Have received medication for negative inotropic other than disopyramide, β-blocker, verapamil, diltiazem 4 weeks before screening.
- History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
- Other conditions that the investigator considers the subject to be unsuitable for participating in this trial, such as physical or psychological diseases or conditions that may increase the risk of the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial.
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Interventions
DRUGHRS-1893 Tablet
HRS-1893 tablet.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07021963
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