Study of FYU-981 in Hyperuricemia With or Without Gout

Phase 2

Completed

• Conditions: Hyperuricemia
• Interventions: Drug: Placebo; Drug: FYU-981

• Registration Number: NCT02416167
• Lead Sponsor: Fuji Yakuhin Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-14
• Study Start: 2015-05
• Primary Completion: 2016-05
• Study Completion: 2016-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Drug: Placebo, (Oral daily dosing for 12 weeks) Subjects randomized to the placebo arm receive placebo.
FYU-981 High dose	FYU-981	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.
FYU-981 High middle dose	FYU-981	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.
FYU-981 Middle dose	FYU-981	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.
FYU-981 Low dose	FYU-981	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.

Primary Outcome Measures

Name	Time	Method
Percent reduction from baseline in serum urate level at the final visit	12 weeks

Trial Locations

Locations (1)

Japan; 🇯🇵 Tokyo and Other Japanese City, Japan