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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/ 40mg/ 60mg/80mg qd + placebo of febuxostat tablets 20mg/ 40mg/ 60mg/80mg qd, from Week 1 to 36. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with serum uric acid level < 300 μmoL/L at Week 36 | Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with serum uric acid level < 360 μmol/L at week 4,8,12,16,20,24,28,32,36 after administration | at week 4,8,12,16,20,24,28,32,36 after administration | |
| Proportion of subjects with serum uric acid level < 300 μmol/L at week 4,8,12,16,20,24,28,32,36 after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ninghui Yan | Contact | +0518-82342973 | ninghui.yan@hengrui.com | |
| Jing Xu | Contact | +0518-82342973 | jing.xu.jx23@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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| febuxostat tablets + placebo of HR091506 tablets | Drug | febuxostat tablets 20mg/ 40mg/ 60mg/80mg qd + placebo of HR091506 tablets 20mg/ 40mg/ 60mg/80mg qd . from Week 1 to 36. |
|
| at week 4,8,12,16,20,24,28,32,36 after administration |
| Change of serum uric acid level from baseline week 4,8,12,16,20,24,28,32,36 after administration | week 4,8,12,16,20,24,28,32,36 after administration |
| Proportion of subjects with ≥1 gout flare during the 36 weeks treatment stage | during the 36 weeks treatment stage |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |