At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 6,198 enrolled
Drug / intervention
Febuxostat +1 moredrug
Likely dose
Not stated in 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.
A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol in Subjects With Gout and Cardiovascular Comorbidities
In Brief
A Phase 3 clinical trial evaluating Febuxostat and Allopurinol for Cardiovascular Disease. Completed, enrolled 6,198 participants across 203 sites in 2 countries.
Detailed Summary
The purpose of this study is to see whether subjects with gout who receive febuxostat or allopurinol for up to 9 years have a higher rate of serious heart and blood vessel complications (major cardiovascular events).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Disease
CountriesMexico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartApr 2010
Primary CompletionMay 2017
Study CompletionJul 2017
TodayJul 2026
First PostedApr 9, 2010
Enrollment StartApr 23, 2010
Primary CompletionMay 15, 2017
Study CompletionJul 18, 2017
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 16.2 years ago
Interventions
Febuxostatdrug
Febuxostat tablets
Allopurinoldrug
Allopurinol tablets