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

Overview

FYU-981 or Benzbromarone are administrated to hyperuricemia patients 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.

Full Title of Study: “Benzbromarone-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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 25, 2018

Interventions

  • Drug: FYU-981
    • Oral daily dosing for 14 weeks
  • Drug: Benzbromarone
    • Oral daily dosing for 14 weeks

Arms, Groups and Cohorts

  • Experimental: FYU-981
  • Active Comparator: Benzbromarone

Clinical Trial Outcome Measures

Primary Measures

  • Percent reduction from baseline in serum urate level at the final visit
    • Time Frame: 14 weeks
    • Percent reduction from baseline in serum urate level at the final visit

Participating in This Clinical Trial

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
  • Hepatic dysfuction, or AST: >=100 IU/L or ALT: >=100 IU/L at the pre-examination
  • eGFR: < 30mL/min/1.73m^2
  • Systolic blood pressure: >= 180 mmHg
  • Diastolic blood pressure: >= 110 mmHg

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fuji Yakuhin Co., Ltd.
  • Collaborator
    • Mochida Pharmaceutical Company, Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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