Study of FYU-981 in Hyperuricemia With or Without Gout

Fuji Yakuhin

Status and phase: Completed; Phase 2

Conditions: Hyperuricemia

Treatments: Drug: FYU-981; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02416167

FYU-981-006

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 5 patient groups, including a placebo group

FYU-981 High dose

Active Comparator group

Description:

Drug: FYU-981 High dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 High dose arm receive active drug, FYU-981 High dose.

Treatment:

Drug: FYU-981

FYU-981 High middle dose

Active Comparator group

Description:

Drug: FYU-981 High middle dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 High middle dose arm receive active drug, FYU-981 High middle dose.

Treatment:

Drug: FYU-981

FYU-981 Middle dose

Active Comparator group

Description:

FYU-981 Middle dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 Middle dose arm receive active drug, FYU-981 Middle dose.

Treatment:

Drug: FYU-981

FYU-981 Low dose

Active Comparator group

Description:

Drug: FYU-981 Low dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 Low dose arm receive active drug, FYU-981 Low dose.

Treatment:

Drug: FYU-981

Placebo

Placebo Comparator group

Description:

Drug: Placebo, (Oral daily dosing for 12 weeks) Subjects randomized to the placebo arm receive placebo.

Treatment:

Drug: Placebo