Study of FYU-981 in Hyperuricemia With or Without Gout

Conditions

Hyperuricemia

Brief summary

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.

Toshinari Takahashi, Takanobu Beppu, Yuji Hidaka, Tatsuo Hosoya

Clinical and Experimental Hypertension2021-08-2324 citations

10.1080/10641963.2021.1950752

Dotinurad versus benzbromarone in Japanese hyperuricemic patient with or without gout: a randomized, double-blind, parallel-group, phase 3 study.

Hosoya T, Sano T, Sasaki T, Fushimi M, Ohashi T.

2020-01-2436 citations

10.1007/s10157-020-01849-0

Open-label study of long-term administration of dotinurad in Japanese hyperuricemic patients with or without gout.

Hosoya T, Fushimi M, Okui D, Sasaki T, Ohashi T.

2019-12-2622 citations

10.1007/s10157-019-01831-5

Clinical efficacy and safety of dotinurad, a novel selective urate reabsorption inhibitor, in Japanese hyperuricemic patients with or without gout: randomized, multicenter, double-blind, placebo-controlled, parallel-group, confirmatory phase 2 study.

Hosoya T, Sano T, Sasaki T, Fushimi M, Ohashi T.

2019-12-0322 citations

10.1007/s10157-019-01818-2

Clinical efficacy and safety of dotinurad, a novel selective urate reabsorption inhibitor, in Japanese hyperuricemic patients with or without gout: an exploratory, randomized, multicenter, double-blind, placebo-controlled, parallel-group early phase 2 study

Tatsuo Hosoya, Takafumi Sano, Tomomitsu Sasaki, Masahiko Fushimi, Tetsuo Ohashi

Clinical and Experimental Nephrology2019-11-2118 citations

10.1007/s10157-019-01802-w

Interventions

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

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

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

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

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

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

DRUGPlacebo, (Oral daily dosing for 8 weeks)

Subjects randomized to the placebo arm receive placebo.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 64 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Percent reduction from baseline in serum urate level at the final visit	8 weeks

Countries

Japan

Outcome results

None listed