Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

Mochida Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Hyperuricemia With or Without Gout

Treatments

Drug: FYU-981

Drug: Febuxostat

Study type

Interventional

Funder types

Industry

Identifiers

NCT03372200

FYU-981-014

Details and patient eligibility

About

FYU-981 or Febuxostat are administrated to hyperuricemia patients (underexcretion and mixed types) with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.

Enrollment

203 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Serum urate level:
- >= 7.0mg/dL in patients with gouty nodule or with history of gout, or >= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL
Disease type in the classification of hyperuricemia: Uric acid-underexcretion type or mixed type
Outpatients

Exclusion criteria

Gouty arthritis within 14 days before randomized allocation
Secondary hyperuricemia
HbA1c: >= 8.4%
Clinically significant cardiac, hepatic, renal, hematologic or endocrine disease
Kidney calculi or clinically significant urinary calculi
AST: >= 100 IU/L or ALT: >= 100 IU/L
eGFR: < 30 mL/min/1.73m^2
Systolic blood pressure: >= 180 mmHg or diastolic blood pressure: >= 110 mmHg