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The study is being conducted to evaluate the efficacy and safety of HR091506 tablets for treatment of primary 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 | Experimental | HR091506 tablets + placebo of febuxostat tablets |
|
| Treatment group B | Active Comparator | febuxostat tablets + placebo of HR091506 tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR091506 tablets + placebo of febuxostat tablets | Drug | HR091506 tablets 40mg qd + placebo of febuxostat tablets 40mg qd in Week 1 and 2, HR091506 tablets 80mg qd + placebo of febuxostat tablets 80mg qd in Week 3 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with serum uric acid level < 360μmol/L on Day 15. | on Day 15. | |
| Proportion of subjects with serum uric acid level < 360μmol/L at test of cure (TOC) | Test of cure, defined as the day after end of treatment, equivalent to Study Day 15 or 29 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with serum uric acid level < 300μmol/L on Day 15. | on Day 15. | |
| Proportion of subjects with serum uric acid level < 360μmol/L at TOC | Test of cure, defined as the day after end of treatment, equivalent to Study Day 15 or 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huize Han | Contact | +0518-82342973 | huize.han@hengrui.com |
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| ID | Term |
|---|---|
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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HR091506 tablets compared with febuxostat tablets
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| febuxostat tablets + placebo of HR091506 tablets | Drug | febuxostat tablets 40mg qd + placebo of HR091506 tablets 40mg qd in Week 1 and 2, febuxostat tablets 80mg qd + placebo of HR091506 tablets 80mg qd in Week 3 and 4 |
|
| The proportion of subjects with serum uric acid level < 360μmol/L on Day 29. | on Day 29. |
| The proportion of subjects with serum uric acid level < 300μmol/L on Day 29. | on Day 29. |
| Change of serum uric acid level from baseline on Day 15 | from baseline on Day 15 |
| Change of serum uric acid level from baseline on Day 29 | from baseline on Day 29 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |