CompletedPhase 3
Clinical Study of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
Key facts
- Who runs it
- Jiangsu HengRui Medicine Co., Ltd.
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 3
- People taking part
- 765 people enrolled
- Started
- 14 Dec 2023
- Ended
- 4 Sept 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- HR091506 tablets + placebo of febuxostat tablets
- febuxostat tablets + placebo of HR091506 tablets
- Record updated
- 2 October 2025
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Combined use of prohibited drugs
- Participated in other clinical trials within 1 month 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
- Allergic to ingredient or component of the experimental drug
- 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
- Abnormal laboratory tests that may affect subjects participating in the research
- Pregnant or nursing women
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 doses.
The 2 groups in the trial
- Treatment group A: HR091506 tablets + placebo of febuxostat tabletsTreatment being tested
Treatment: HR091506 tablets + placebo of febuxostat tablets
- Treatment group B: febuxostat tablets + placebo of HR091506 tabletsExisting treatment, for comparison
Treatment: febuxostat tablets + placebo of HR091506 tablets
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Study on Efficacy and Safety of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
- Record updated
- 2 October 2025