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NCT Number: NCT03100318

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

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.

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Key information

Conditions

Hyperuricemia With or Without Gout

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tokyo

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FYU-981

Drug

Oral daily dosing for 14 weeks

Benzbromarone

Drug

Oral daily dosing for 14 weeks

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fuji Yakuhin Co., Ltd.

Industry

Collaborators

  • Mochida Pharmaceutical Company, Ltd.

Registry information

Official study title

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)

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2017
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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