CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,269 enrolled
Drug / intervention
Febuxostat +2 moredrug
Likely dose
Febuxostat 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00430248
NCT00430248Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat in Subjects With Gout.

Takeda·interventional·Posted Feb 1, 2007·Updated Feb 2, 2012

In Brief

A Phase 3 clinical trial evaluating Febuxostat and Allopurinol for Gout. Completed, enrolled 2,269 participants across 258 sites.

Detailed Summary

The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 1, 2007
Enrollment StartFeb 1, 2007
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 19.4 years ago

Interventions

Febuxostatdrug

Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.

Febuxostatdrug

Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.

Allopurinoldrug

Allopurinol 200 mg or 300 mg, capsules, orally, once daily for up to 6 months. Dose is dependent on the subject's renal function. Subjects with normal renal function or mild renal impairment received 300 mg once daily; subjects with moderate renal impairment received 200 mg once daily.