Status:
COMPLETED
Drug Use Study of Febuxostat After Recent Changes in the Prescribing Information
Lead Sponsor:
Takeda
Conditions:
Gout
Cardiovascular Diseases
Eligibility:
All Genders
21+ years
Brief 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 cha...
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), bas...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Index fill date on or after 01 June 2016.
- Having at least one diagnosis for gout (identified with diagnosis codes, International Classification of Diseases, clinical modification, ninth revision \[ICD-9-CM\]: 274.x or International Classification of Diseases, tenth revision \[ICD-10\]: M10.x) at any time in the participant's record.
- Continuously enrolled for at least 12 months prior to index fill date.
Exclusion
Key Trial Info
Start Date :
August 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 5 2021
Estimated Enrollment :
24046 Patients enrolled
Trial Details
Trial ID
NCT04853160
Start Date
August 15 2020
End Date
January 5 2021
Last Update
April 27 2021
Active Locations (1)
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1
Central Contact
Cambridge, Massachusetts, United States, 02142