Back to results

Study of FYU-981 in Hyperuricemia With or Without Gout

Primary Purpose

Hyperuricemia With or Without Gout

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

FYU-981

About this trial

This is an interventional treatment trial for Hyperuricemia With or Without Gout

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FYU-981

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03006445

First Posted

December 28, 2016

Last Updated

December 4, 2018

Sponsor

Fuji Yakuhin Co., Ltd.

Collaborators

Mochida Pharmaceutical Company, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03006445

Brief Title

Study of FYU-981 in Hyperuricemia With or Without Gout

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

December 2016 (Actual)

Primary Completion Date

August 23, 2018 (Actual)

Study Completion Date

October 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fuji Yakuhin Co., Ltd.

Collaborators

Mochida Pharmaceutical Company, Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperuricemia With or Without Gout

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

330 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FYU-981

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

FYU-981

Primary Outcome Measure Information:

Title

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

Time Frame

34 or 58 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

31875931

Citation

Hosoya T, Fushimi M, Okui D, Sasaki T, Ohashi T. Open-label study of long-term administration of dotinurad in Japanese hyperuricemic patients with or without gout. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):80-91. doi: 10.1007/s10157-019-01831-5. Epub 2019 Dec 26.

Results Reference

derived

Learn more about this trial

Study of FYU-981 in Hyperuricemia With or Without Gout

We'll reach out to this number within 24 hrs