Study of FYU-981 in Hyperuricemia With or Without Gout

Fuji Yakuhin Co., Ltd.80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hyperuricemia

Interventions

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.

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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: \< 60mL/min/1.73m\^2 * Systolic blood pressure: \>= 180 mmHg * Diastolic blood pressure: \>= 110 mmHg

Locations (1)

Japan

Tokyo, Japan

Outcomes

Primary Outcomes

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

Time frame: 8 weeks

Data from ClinicalTrials.gov

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