Study of FYU-981 in Hyperuricemia With or Without Gout

Study Overview
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Brief Summary
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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.

Official Title
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Confirmatory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIb) Study)

Conditions
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Hyperuricemia

Intervention / Treatment
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* Drug: FYU-981
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FYU-981 High dose<br>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. | Drug: FYU-981<br> <br> |
| Active Comparator: FYU-981 High middle dose<br>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. | Drug: FYU-981<br> <br> |
| Active Comparator: FYU-981 Middle dose<br>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. | Drug: FYU-981<br> <br> |
| Active Comparator: FYU-981 Low dose<br>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. | Drug: FYU-981<br> <br> |
| Placebo Comparator: Placebo<br>Drug: Placebo, (Oral daily dosing for 12 weeks) Subjects randomized to the placebo arm receive placebo. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction from baseline in serum urate level at the final visit |  | 12 weeks |