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

Last updated: September 24, 2018
Sponsor: Fuji Yakuhin Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Gout (Hyperuricemia)

Arthritis And Arthritic Pain (Pediatric)

Collagen Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT03100318
FYU-981-011
  • Ages > 20
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 201
Study Start date:
April 01, 2017
Estimated Completion Date:
August 31, 2018

Connect with a study center

  • Fuji Yakuhin Co., Ltd.

    Saitama-shi, Saitama 330-9508
    Japan

    Site Not Available

  • Tokyo

    Tokyo,
    Japan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.