Overview

This trial is active, not recruiting.

Condition hyperuricemia
Treatments fyu-981, placebo
Phase phase 2
Sponsor Fuji Yakuhin Co., Ltd.
Start date May 2015
End date September 2016
Trial size 200 participants
Trial identifier NCT02416167, FYU-981-006

Summary

The purpose of this study is confirmatory 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 12 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 8 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Drug: FYU-981 High dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 High dose arm receive active drug, FYU-981 High dose.
fyu-981
(Active Comparator)
Drug: FYU-981 High middle dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 High middle dose arm receive active drug, FYU-981 High middle dose.
fyu-981
(Active Comparator)
FYU-981 Middle dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 Middle dose arm receive active drug, FYU-981 Middle dose.
fyu-981
(Active Comparator)
Drug: FYU-981 Low dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 Low dose arm receive active drug, FYU-981 Low dose.
fyu-981
(Placebo Comparator)
Drug: Placebo, (Oral daily dosing for 12 weeks) Subjects randomized to the placebo arm receive placebo.
placebo

Primary Outcomes

Measure
Percent reduction from baseline in serum urate level at the final visit
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Confirmatory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIb) Study)
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Fuji Yakuhin Co., Ltd..