Febuxostat-5006: 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 (Febuxostat Drug Utilization Study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48592
• EU PAS number:
  EUPAS40179
• Study ID:
  48592
• Official title and acronym:
  Febuxostat-5006: 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 (Febuxostat Drug Utilization Study)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Actual: 20/01/2021

Study start date

Actual: 15/08/2020

Data analysis start date

Actual: 05/01/2021

Date of final study report

Planned: 30/06/2021

Actual: 30/06/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Study protocol

Initial protocol

Febuxostat-5006_Protocol-V2-Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable