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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HR091506 tablets + placebo of febuxostat tablets | Experimental |
| |
| Treatment group B: febuxostat tablets + placebo of HR091506 tablets | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR091506 tablets + placebo of febuxostat tablets | Drug | HR091506 tablets 20mg qd + placebo of febuxostat tablets 20mg qd from Week 1 to 4, HR091506 tablets 40mg qd + placebo of febuxostat tablets 40mg qd from Week 5 to 28. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with serum uric acid level < 360 μmoL/L at Week 28 | Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with serum uric acid level < 360 μmol/L at each visit. | at week 4,8,12,16,20and24 after administration | |
| Proportion of subjects with serum uric acid level < 300 μmol/L at each visit | at week 4,8,12,16,20,24and28 after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| febuxostat tablets + placebo of HR091506 tablets | Drug | febuxostat tablets 20mg qd + placebo of HR091506 tablets 20mg qd from Week 1 to 4, febuxostat tablets 40mg qd + placebo of HR091506 tablets 40mg qd from Week 5 to 28. |
|
| Change of serum uric acid level from baseline to every visit | at week 4,8,12,16,20,24 and28 after administration |
| Proportion of subjects with ≥1 gout flare during treatment stage | during treatment stage |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |