drugset / Trial / NCT01101035

Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES)

NCT01101035

Phase 3 Completed 6198 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2010-04-23
Primary completion
2017-05-15
Completion
2017-07-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Allopurinol Small molecule 200 mg Oral
Comparator Allopurinol Small molecule 300 mg Oral
Comparator Allopurinol Small molecule 400 mg Oral
Comparator Allopurinol Small molecule 500 mg Oral
Comparator Allopurinol Small molecule 600 mg Oral
Subject Febuxostat Small molecule 40 mg Oral
Subject Febuxostat Small molecule 80 mg Oral