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Study of FYU-981 in Hyperuricemia With or Without Gout | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of FYU-981 in Hyperuricemia With or Without Gout

Official Title: Safety and Efficacy Evaluation Study of FYU-981 Long-term Administration for Hyperuricemia With or Without Gout (Phase III Study)

NCT03006445•Fuji Yakuhin Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and ascending dose regimen.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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: \< 30mL/min/1.73m\^2
•Systolic blood pressure: \>= 180 mmHg
•Diastolic blood pressure: \>= 110 mmHg

Locations (1)

Tokyo, Japan

Key Dates

Start Date

December 1, 2016

Primary Completion Date

August 23, 2018

Completion Date

October 24, 2018

Last Updated

December 6, 2018

Enrollment

330

ACTUAL participants

Conditions

Hyperuricemia With or Without Gout

Interventions

FYU-981

DRUG

The Effects of a Probiotic Food Supplement in Hyperuricaemia

NCT07141888

Hyperuricemia With or Without Gout

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COMPLETEDPHASE1

Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)

NCT03375632

Hyperuricemia With or Without Gout

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 6, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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