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| Name | Class |
|---|---|
| Mochida Pharmaceutical Company, Ltd. | INDUSTRY |
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The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and ascending dose regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FYU-981 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FYU-981 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent reduction from baseline in serum urate level at the final visit | 34 or 58 weeks |
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Inclusion Criteria:
>= 7.0mg/dL in patients with history of gout, or >= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40839334 | Derived | Takahashi T, Beppu T, Hosoya T, Yokota N. Changes in urinary albumin levels with dotinurad oral administration in hyperuricemic patients with microalbuminuria: a post hoc analysis. Clin Exp Nephrol. 2025 Oct;29(10):1384-1393. doi: 10.1007/s10157-025-02750-4. Epub 2025 Aug 21. | |
| 31875931 | Derived | Hosoya T, Fushimi M, Okui D, Sasaki T, Ohashi T. Open-label study of long-term administration of dotinurad in Japanese hyperuricemic patients with or without gout. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):80-91. doi: 10.1007/s10157-019-01831-5. Epub 2019 Dec 26. |
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| ID | Term |
|---|---|
| C000706811 | dotinurad |
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