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The objective of the study is to assess efficacy and safety of SHR4640 in subjects with hyperuricemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo for 5 weeks |
|
| 2.5mg SHR4640 | Experimental | SHR4640 for 5 weeks |
|
| 5mg SHR4640 | Experimental | SHR4640 for 5 weeks |
|
| 10mg SHR4640 | Experimental | SHR4640 for 5 weeks |
|
| 50mg benzbromarone | Active Comparator | Benzbromarone for 5 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo once daily for 5 weeks |
| |
| SHR4640 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a serum uric level≤360μmol/l. | Week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Actual change from baseline in serum uric level. | Week 5 | |
| Percentage change from baseline in serum uric level . | Week 5 | |
| Rate of gout flares requiring treatment. |
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Inclusion Criteria:
1) Subject with a history of gout has a serum uric acid ≥480μmol/l at screening; 2) Subject with a history of hyperuricemia has a serum uric acid ≥540μmol/l at screening, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3) Subject with a history of hyperuricemia has a serum uric acid≥480μmol/l at screening, on stable treatment for hypertensive, hyperlipidemia or diabetes for at least 3 month, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3. 18kg/m2≤ BMI ≤32kg/m2.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chunde Bao | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Hengrui Medicine Co., Ltd. | Shanghai | Shanghai Municipality | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33693494 | Derived | Lin Y, Chen X, Ding H, Ye P, Gu J, Wang X, Jiang Z, Li D, Wang Z, Long W, Li Z, Jiang G, Li X, Bi L, Jiang L, Wu J, Guo L, Cai X, Lu X, Chen Q, Chen H, Peng A, Zuo X, Ning R, Zhang Z, Tai Y, Zhang T, Bao C. Efficacy and safety of a selective URAT1 inhibitor SHR4640 in Chinese subjects with hyperuricaemia: a randomized controlled phase II study. Rheumatology (Oxford). 2021 Nov 3;60(11):5089-5097. doi: 10.1093/rheumatology/keab198. |
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000720748 | ruzinurad |
| D001553 | Benzbromarone |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
1mg SHR4640 once daily for a week, 2.5mg, 5mg or 10mg SHR4640 once daily for 4 weeks |
|
| benzbromarone | Drug | 25mg benzbromarone once daily for a week, 50mg benzbromarone once daily for 4 weeks |
|
| Up to week 5 |
| Incidence of gout flares requiring treatment. | Up to week 5 |
| Proportion of subjects with a serum uric level≤360μmol/l | At week1, 2, 3 and 4 |
| Proportion of subjects with a serum uric level consistent ≤360μmol/l | At week 3, 4 and 5 |
| Actual change from baseline in serum uric level | At week 1, 2, 3 and 4 |
| Percentage change from baseline in serum uric level | At week 1, 2, 3 and 4 |