Status:
COMPLETED
A Study of HRS-9057 in Patients With Heart Failure and Volume Overload
Lead Sponsor:
Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions:
Heart Failure With Volume Overload
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The study is an open-label, Tolvaptan-controlled Phase I study to evaluate the safety, tolerability, PK/PD profile and efficacy of HRS-9057 in the treatment of heart failure with volume overload. A to...
Eligibility Criteria
Inclusion
- Male or female, age 18-75 years at the time of signing informed consent.
- Diagnosed as chronic heart failure at least 1 month prior to screening.
- Patients with CHF in whom lower limb edema, pulmonary congestion, jugular venous distension or hepatomegaly due to volume overload is present despite diuretics treatment.
Exclusion
- Medical history of myocardial infarction, acute decompensated heart failure, stroke, or transient ischemic attack within 30 days prior to or at screening;
- Hypovolemic hyponatremia.
Key Trial Info
Start Date :
August 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06506994
Start Date
August 16 2024
End Date
October 29 2025
Last Update
November 17 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510285