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

Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 for Hyperuricemia With or Without Gout to Evaluate the Safety and Noninferiority of FYU-981 (Phase III Study)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03372200

Enrollment

203

Registered

2017-12-13

Start date

2018-01-09

Completion date

2018-07-05

Last updated

2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperuricemia With or Without Gout

Brief summary

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.

Interventions

DRUGFYU-981

Oral daily dosing for 14 weeks

DRUGFebuxostat

Oral daily dosing for 14 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Percent reduction from baseline in serum urate level at the final visit	14 weeks	Percent reduction from baseline in serum urate level at the final visit

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026