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

NCT03372200 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2018-09-24

No results posted yet for this study

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.

Conditions

  • Hyperuricemia With or Without Gout

Interventions

DRUG

FYU-981

Oral daily dosing for 14 weeks

DRUG

Febuxostat

Oral daily dosing for 14 weeks

Sponsors & Collaborators

  • Fuji Yakuhin Co., Ltd.

    collaborator INDUSTRY

  • Mochida Pharmaceutical Company, Ltd.

    lead INDUSTRY

Principal Investigators

  • Kazuki Furuno · Clinical Research Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-09
Primary Completion
2018-06-04
Completion
2018-07-05

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03372200 on ClinicalTrials.gov