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Completed

NCT Number: NCT02344862

Study of FYU-981 in Hyperuricemia With or Without Gout

The purpose of this study is exploratory investigation of safety and efficacy (dose response and optimal dose according to the percent reduction from baseline in serum urate level at the final visit) of FYU-981 administered orally to hyperuricemic patients with and without gout for 8 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 4 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.

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Key information

Conditions

Hyperuricemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Japan

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
  • eGFR: < 60mL/min/1.73m^2
  • Systolic blood pressure: >= 180 mmHg
  • Diastolic blood pressure: >= 110 mmHg

Treatment and study plan

FYU-981 High dose, (Oral daily dosing for 8 weeks)

Drug

Subjects randomized to the FYU-981 High dose arm receive active drug, FYU-981 High dose.

FYU-981 Middle dose, (Oral daily dosing for 8 weeks)

Drug

Subjects randomized to the FYU-981 Middle dose arm receive active drug, FYU-981 Middle dose.

FYU-981 Low dose, (Oral daily dosing for 8 weeks)

Drug

Subjects randomized to the FYU-981 Low dose arm receive active drug, FYU-981 Low dose.

Placebo, (Oral daily dosing for 8 weeks)

Drug

Subjects randomized to the placebo arm receive placebo.

Primary outcomes

  1. Percent reduction from baseline in serum urate level at the final visit

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Fuji Yakuhin Co., Ltd.

Industry

Registry information

Official study title

Exploratory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIa) Study)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 26, 2015
Registry last updated
Jan 26, 2015

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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