Study of FYU-981 in Hyperuricemia With or Without Gout

Phase 2

Completed

• Conditions: Hyperuricemia
• Interventions: Drug: Placebo, (Oral daily dosing for 8 weeks); Drug: FYU-981 Middle dose, (Oral daily dosing for 8 weeks); Drug: FYU-981 High dose, (Oral daily dosing for 8 weeks); Drug: FYU-981 Low dose, (Oral daily dosing for 8 weeks)

• Registration Number: NCT02344862
• Lead Sponsor: Fuji Yakuhin Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-07
• Study Completion: 2014-09
• Status Verified: 2015-01
• Study First Submitted: 2015-01-18
• Study First Submitted QC: 2015-01-22
• Last Update Submitted: 2015-01-22
• Study First Posted: 2015-01-26
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo, (Oral daily dosing for 8 weeks)	-
FYU-981 Middle dose	FYU-981 Middle dose, (Oral daily dosing for 8 weeks)	-
FYU-981 High dose	FYU-981 High dose, (Oral daily dosing for 8 weeks)	-
FYU-981 Low dose	FYU-981 Low dose, (Oral daily dosing for 8 weeks)	-

Primary Outcome Measures

Name	Time	Method
Percent reduction from baseline in serum urate level at the final visit	8 weeks

Trial Locations

Locations (1)

Japan; 🇯🇵 Tokyo, Japan