Hyperuricemia With or Without Gout
Conditions
Brief summary
The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and ascending dose regimen.
Interventions
DRUGFYU-981
Sponsors
Mochida Pharmaceutical Company, Ltd.
Fuji Yakuhin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent reduction from baseline in serum urate level at the final visit | 34 or 58 weeks |
Countries
Japan
Outcome results
None listed