NCT04853160

Drug Use Study of Febuxostat After Recent Changes in the Prescribing Information

Drug Utilization Study to Describe the Pattern of Febuxostat Use in Relationship to Allopurinol Following Addition of the Boxed Warning and Modification of the Indication Based on the Results of the CARES Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24,046 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The prescribing information provides information on medicines. This study will check the number of patients starting febuxostat and the number of febuxostat users with cardiovascular disease after changes to the prescribing information.

Detailed description

This is a descriptive, cross-sectional, non-interventional study of participants with gout. The study will evaluate the impact of the 2019 labeling changes (boxed warning and modified indication), based upon results of the cardiovascular safety of febuxostat and allopurinol in participants with gout and cardiovascular morbidities (CARES) trial, on febuxostat utilization. The study will evaluate data from approximately 24046 participants. The data will be collected from optum clinformatics dataMart (CDM) including the medicare advantage administrative US claims database and the IQVIA pharmetrics plus claims database. All participants will be enrolled in a single observational cohort. This trial will be conducted in the United States. The overall duration of this study is approximately 14 months.

Conditions

• Gout
• Cardiovascular Diseases

Timeline

• Start date: 2020-08-15
• Primary completion: 2021-01-05
• Completion: 2021-01-05
• First posted: 2021-04-21
• Last updated: 2021-04-27

Locations

1 site across 1 country: United States