A Study of HRS-9057 in Patients With Heart Failure and Volume Overload
NCT ID: NCT06506994
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2024-08-16
2025-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment group A: HRS-9057/ Tolvaptan
HRS-9057
HRS-9057 injection dose 1
Tolvaptan
Tolvaptan tablets
Treatment group B: HRS-9057/ Tolvaptan
HRS-9057
HRS-9057 injection dose 2
Tolvaptan
Tolvaptan tablets
Interventions
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HRS-9057
HRS-9057 injection dose 1
HRS-9057
HRS-9057 injection dose 2
Tolvaptan
Tolvaptan tablets
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed as chronic heart failure at least 1 month prior to screening.
3. 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 Criteria
2. Hypovolemic hyponatremia.
18 Years
75 Years
ALL
No
Sponsors
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Fujian Shengdi Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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HRS-9057-103
Identifier Type: -
Identifier Source: org_study_id
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