Post-Authorisation Safety Study of Lesinurad - SATURATES
Study identifier:D5310R00016
ClinicalTrials.gov identifier:NCT04072471
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
Post-Authorisation Safety Study of Lesinurad
Medical condition
Gout, Hyperuricemia
Phase
N/A
Healthy volunteers
No
Study drug
Zurampic®, Control group: xanthine oxidase inhibitor monotherapy
Sex
All
Actual Enrollment
0
Study type
Observational
Age
18 Years +
Date
Study Start Date: 29 Jan 2021
Estimated Primary Completion Date: 30 Jun 2023
Estimated Study Completion Date: 30 Jun 2023
Study design
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verification:
Verified 01 Mar 2021 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Zurampic® Patients exposed to Zurampic® plus a xanthine oxidase inhibitor (allopurinol or febuxostat) (lesinurad+XOI) | Drug: Zurampic® non-interventional study where patients are exposed to Zurampic® plus a xanthine oxidase inhibitor (allopurinol or febuxostat) during the normal course of clinical practice Other Name: ATC code: M04A B05 Other Name: Product name*: Zurampic® Other Name: Substance (INN)*: lesinurad |
| Control group: xanthine oxidase inhibitor monotherapy Patients exposed to xanthine oxidase inhibitor monotherapy (allopurinol or febuxostat). | Drug: Control group: xanthine oxidase inhibitor monotherapy non-interventional study where patients are exposed to xanthine oxidase inhibitor monotherapy (allopurinol or febuxostat) during the normal course of clinical practice |
