UnknownPhase 1

A Trial of HR091506 Tablets in Treatment of Primary Gout With Hyperuricemia in Adults

90 participantsStarted 2022-04-30

Plain-language summary

The study is being conducted to evaluate the efficacy and safety of HR091506 tablets for treatment of primary gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 18 - 65 years old, male or female.
✓. BMI: 18.0 - 30 kg/m2.
✓. Meet the 2015 ACR (American College of Rheumatology) gout classification criteria.
✓. Fasting serum uric acid ≥480 μmol/L on 2 different days during the screening period.
✓. Willing to use contraceptive measures during the study.
✓. Able and willing to provide a written informed consent.

Exclusion criteria

✕. History of acute gout attack within 4 weeks before randomization.
✕. Urinary calculi diagnosed by B-ultrasound within 4 weeks before randomization.
✕. Subjects who have undergone major surgery or organ transplantation within 3 months before randomization.
✕. Major cardiovascular disease within 6 months before randomization.
✕. History of chronic infection or recurrent infection within 1 year 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.

What they're measuring

The proportion of subjects with serum uric acid level < 360μmol/L on Day 15.

Timeframe: on Day 15.

Proportion of subjects with serum uric acid level < 360μmol/L at test of cure (TOC)

Timeframe: Test of cure, defined as the day after end of treatment, equivalent to Study Day 15 or 29

Trial details

NCT IDNCT05347498

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-31

Contact for this trial

Huize Han

+0518-82342973 huize.han@hengrui.com

View on ClinicalTrials.gov More Primary Gout With Hyperuricemia in Adults trials