Study of FYU-981 in Hyperuricemia With or Without Gout
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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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Layout table for eligibility information
Ages Eligible for Study:
20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Hyperuricemic or gout patients
Serum urate level:
>= 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
Gouty arthritis within two weeks before start of study treatment
HbA1c: >= 8.4%
Uric acid-overproduction type in the classification of hyperuricemia
History of, clinically significant cardiac, hematologic and hepatic disease
Kidney calculi or clinically significant urinary calculi