Status:
COMPLETED
Clinical Study of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Gout With Hyperuricemia in Adults
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The study is being conducted to evaluate the efficacy, and safety of HR091506 tablets for treatment of gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same...
Eligibility Criteria
Inclusion
- 18-75 years old, male or female;
- BMI: 18.0-30.0 kg/m2;
- Meet the 2015 ACR/EULAR gout classification criteria;
- Fast serum uric acid ≥ 480 μmol/L on 2 different days during the screening perid;
- Willing to ues contraceptive measures during the study;
- Able and willing to provide a written informed consent.
Exclusion
- History of acute gout attack within 4 weeks before randomization.
- Subjects who have undergone major surgery or organ transplantation within 3 months before randomization.
- Subjects with major cardiovascular disease within 6 months before randomization.
- History of chronic infection or recurrent infection within 1year before randomization.
- History of malignant tumor or current history of combined malignant tumor within 5 years before screening.
- History of secondary hyperuricemia, refractory gout, or xanthine metabolism disorder.
- Subjects with poorly controlled blood pressure or diabetes mellitus.
- History of chronic diffuse connective tissue disease and/or massively elevated urate diseases and/or untreated clinically significant thyroid disease.
- History of diseases that may affect the in vivo process, safety evaluation, or subjects' participation in the research.
- Abnormal laboratory tests that may affect subjects participating in the research.
- Combined use of prohibited drugs.
- Allergic to ingredient or component of the experimental drug.
- Participated in other clinical trials within 1 month before randomization.
- Pregnant or nursing women.
- History of drug abuse, drug use and/or excessive drinking within 1 year before screening.
- The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Key Trial Info
Start Date :
December 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2025
Estimated Enrollment :
765 Patients enrolled
Trial Details
Trial ID
NCT06139393
Start Date
December 14 2023
End Date
September 4 2025
Last Update
October 2 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034