Study of FYU-981 in Hyperuricemia With or Without Gout
This trial is active, not recruiting.
|Sponsor||Fuji Yakuhin Co., Ltd.|
|Start date||May 2015|
|End date||September 2016|
|Trial size||200 participants|
|Trial identifier||NCT02416167, FYU-981-006|
The purpose of this study is confirmatory 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 12 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 8 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Percent reduction from baseline in serum urate level at the final visit
time frame: 12 weeks
Male or female participants at least 20 years old.
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
|Official title||Confirmatory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIb) Study)|
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