Clinical Trial of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults (NCT06414837) | Clinical Trial Compass
UnknownPhase 3
Clinical Trial of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
434 participantsStarted 2024-06
Plain-language 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 doses.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18-75 years old, male or female;
. Meet the 2015 ACR/EULAR gout classification criteria;
. Fast serum uric acid ≥ 480 μmol/L on 2 different days during the screening perid;
. Patients with tophi, chronic arthropathy, frequent attacks;
. Willing to ues 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a tablet called HR091506 and measuring whether it can bring serum uric acid below 300 μmol/L by Week 36 — is that target level appropriate for my current uric acid readings, and how does it compare to what existing approved medications could achieve for me?
2Since this is a Phase 3 trial, there should be more safety data available than earlier phases — can you tell me what is known so far about the side effects of HR091506, and how that compares to gout medications I could take right now?
3The recruitment status for this trial is listed as unknown, so can you help me find out whether it is actually open and enrolling, and if so, where the study sites are and whether the 36-week commitment is realistic given my schedule and how active my gout is?
4Before considering this trial, should I try a standard urate-lowering therapy like allopurinol or febuxostat first, and would starting one of those now affect my eligibility for this study later?
5Given that the main goal is measured at Week 36, what happens to my gout management if I need to leave the trial early, or if HR091506 isn't working well enough for me partway through?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of subjects with serum uric acid level < 300 μmoL/L at Week 36