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Terminated/Withdrawn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

Study drug

Zurampic®, Control group: xanthine oxidase inhibitor monotherapy

Sex

All

Actual Enrollment

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

Collaborators

Inclusion and exclusion criteria

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

"There is no result for the study"

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com