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This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to Allopurinol in subjects with gout.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | SHR4640+Allopurinol Placebo；once a day, orally, for 52 weeks |
|
| Treatment group B | Active Comparator | Allopurinol+ SHR4640 Placebo；once a day, orally, for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR4640 | Drug | SHR4640 Dose 1 ,tablets, QD |
| |
| Allopurinol |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a serum uric acid level≤360 μmol/L | Start of Treatment to end of study (approximately 16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in serum uric acid from baseline at each visit during 16 weeks of treatment | Start of Treatment to end of study (approximately 16 weeks) | |
| Absolute changes in serum uric acid from baseline at each visit during 16 weeks of treatment | Start of Treatment to end of study (approximately 16 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RenJi Hospital, Shanghai JiaoTong University School Of Medicine | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| C000720748 | ruzinurad |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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To evaluate the efficacy and safety of SHR4640 monotherapy tablets in patients with gout
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| Drug |
Allopurinol 300mg, tablets, QD |
|
| The proportion of subjects with A serum uric acid level≤ 360 μmol/L at each visit within 16 weeks of treatment | Start of Treatment to end of study (approximately 16 weeks) |
| Percentage change of serum uric acid from baseline at each visit within 52 weeks of treatment | Start of Treatment to end of study (approximately 52 weeks) |
| change value of serum uric acid from baseline at each visit within 52 weeks of treatment | Start of Treatment to end of study (approximately 52 weeks) |
| proportion of subjects with serum uric acid ≤ 360 μmol/L at each visit within 52 weeks of treatment | Start of Treatment to end of study (approximately 52 weeks) |
| serum uric acid value at each visit within 52 weeks of treatment | Start of Treatment to end of study (approximately 52 weeks) |
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |