Study of FYU-981 in Hyperuricemia With or Without Gout
Hyperuricemia
About this trial
This is an interventional treatment trial for Hyperuricemia
Eligibility Criteria
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
Sites / Locations
- Japan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
FYU-981 High dose
FYU-981 High middle dose
FYU-981 Middle dose
FYU-981 Low dose
Placebo
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 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, (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 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: Placebo, (Oral daily dosing for 12 weeks) Subjects randomized to the placebo arm receive placebo.