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This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to placebo and Allopurinol in patients with gout
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo once a day, orally, for 12 weeks, followed by SHR4640 treatment to 36 weeks |
|
| SHR4640 dose1 | Experimental | SHR4640 dose1 once a day, orally, for 36 weeks |
|
| SHR4640 dose2 | Experimental | SHR4640 dose2 once a day, orally, for 36 weeks |
|
| Allopurinol | Active Comparator | Allopurinol 300mg (milligram) once a day, Orally, for 36 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR4640 dose1 | Drug | tablets,dose1,QD |
| |
| SHR4640 dose2 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a serum uric level≤360μmol/l. | Proportion of subjects with a serum uric level≤360μmol/l. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a serum uric level≤360μmol/l | Proportion of subjects with a serum uric level≤360μmol/l | Week 36 |
| Percentage change from baseline in serum uric level | Percentage change from baseline in serum uric level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chunde Bao | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RenJi Hospital Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200000 | 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 |
|---|---|
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
tablets,dose2,QD |
|
| Placebo oral tablet | Drug | tablets,QD |
|
| Allopurinol 300 MG | Drug | tablets,300mg,QD |
|
| Up to 36 weeks |
| Actual change from baseline in serum uric level | Actual change from baseline in serum uric level | Up to 36 weeks |
| Proportion of subjects with a serum uric level≤360μmol/l | Proportion of subjects with a serum uric level≤360μmol/l | Up to 36 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 |