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The purpose of this study is exploratory investigation of safety and efficacy (dose response and optimal dose according to the percent reduction from baseline in serum urate level at the final visit) of FYU-981 administered orally to hyperuricemic patients with and without gout for 8 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 4 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FYU-981 High dose | Active Comparator |
| |
| FYU-981 Middle dose | Active Comparator |
| |
| FYU-981 Low dose | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FYU-981 High dose, (Oral daily dosing for 8 weeks) | Drug | Subjects randomized to the FYU-981 High dose arm receive active drug, FYU-981 High dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent reduction from baseline in serum urate level at the final visit | 8 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 |
|---|---|---|---|---|---|---|
| Japan | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31754882 | Derived | Hosoya T, Sano T, Sasaki T, Fushimi M, Ohashi T. Clinical efficacy and safety of dotinurad, a novel selective urate reabsorption inhibitor, in Japanese hyperuricemic patients with or without gout: an exploratory, randomized, multicenter, double-blind, placebo-controlled, parallel-group early phase 2 study. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):44-52. doi: 10.1007/s10157-019-01802-w. Epub 2019 Nov 21. |
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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 |
|---|---|
| C000706811 | dotinurad |
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| FYU-981 Middle dose, (Oral daily dosing for 8 weeks) | Drug | Subjects randomized to the FYU-981 Middle dose arm receive active drug, FYU-981 Middle dose. |
|
| FYU-981 Low dose, (Oral daily dosing for 8 weeks) | Drug | Subjects randomized to the FYU-981 Low dose arm receive active drug, FYU-981 Low dose. |
|
| Placebo, (Oral daily dosing for 8 weeks) | Drug | Subjects randomized to the placebo arm receive placebo. |
|