Trials / Completed
CompletedNCT02416167
Study of FYU-981 in Hyperuricemia With or Without Gout
Confirmatory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIb) Study)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Fuji Yakuhin Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FYU-981 | |
| DRUG | Placebo |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2016-05-01
- Completion
- 2016-11-01
- First posted
- 2015-04-14
- Last updated
- 2017-02-14
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02416167. Inclusion in this directory is not an endorsement.