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Study of FYU-981 in Hyperuricemia With or Without Gout

Primary Purpose

Hyperuricemia

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
FYU-981
Placebo
Sponsored by
Fuji Yakuhin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperuricemia

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

  • Japan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

FYU-981 High dose

FYU-981 High middle dose

FYU-981 Middle dose

FYU-981 Low dose

Placebo

Arm Description

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.

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 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.

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.

Drug: Placebo, (Oral daily dosing for 12 weeks) Subjects randomized to the placebo arm receive placebo.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 9, 2015
Last Updated
February 13, 2017
Sponsor
Fuji Yakuhin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02416167
Brief Title
Study of FYU-981 in Hyperuricemia With or Without Gout
Official Title
Confirmatory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIb) Study)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuji Yakuhin Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FYU-981 High dose
Arm Type
Active Comparator
Arm Description
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.
Arm Title
FYU-981 High middle dose
Arm Type
Active Comparator
Arm Description
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.
Arm Title
FYU-981 Middle dose
Arm Type
Active Comparator
Arm Description
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.
Arm Title
FYU-981 Low dose
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo, (Oral daily dosing for 12 weeks) Subjects randomized to the placebo arm receive placebo.
Intervention Type
Drug
Intervention Name(s)
FYU-981
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percent reduction from baseline in serum urate level at the final visit
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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:
Facility Name
Japan
City
Tokyo and Other Japanese City
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
31792640
Citation
Hosoya T, Sano T, Sasaki T, Fushimi M, Ohashi T. 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. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):53-61. doi: 10.1007/s10157-019-01818-2. Epub 2019 Dec 3.
Results Reference
derived

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Study of FYU-981 in Hyperuricemia With or Without Gout

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