CompletedPhase 3

Study of FYU-981 in Hyperuricemia With or Without Gout

Japan330 participantsStarted 2016-12

Plain-language summary

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.

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Gouty arthritis within two weeks before start of study treatment * Secondary hyperuricemia * 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 * eGFR: \< 30mL/min/1.73m\^2 * Systolic blood pressure: \>= 180 mmHg * Diastolic blood pressure: \>= 110 mmHg

What they're measuring

Percent reduction from baseline in serum urate level at the final visit

Timeframe: 34 or 58 weeks

Trial details

NCT IDNCT03006445

SponsorFuji Yakuhin Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-08-23

View on ClinicalTrials.gov More Hyperuricemia With or Without Gout trials