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Post-Authorisation Safety Study of Lesinurad

NCT04072471 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2021-04-19

No results posted yet for this study

Summary

Non-interventional population-based prospective cohort study in multiple databases comparing patients with gout who initiate lesinurad in combination with an existing xanthine oxidase inhibitor (XOI) (lesinurad+XOI cohort) to a propensity score-matched cohort of similar patients from the same data source who continue treatment with XOI monotherapy (XOI mono cohort). Study will characterize the cardiovascular safety of lesinurad in combination with XOI in patients with gout aged 18+ years compared with similar patients who continue XOI monotherapy. Primary objective: to assess the relative incidence of major adverse cardiac events plus hospitalization for unstable angina (MACE+ events) in patients with gout in both cohorts. Secondary objectives: to describe the characteristics of the cohorts prior to matching; to assess the relative incidence of hospitalisation for acute kidney injury between the matched cohorts; to assess the relative incidence of individual MACE+ components in the matched cohorts.

Conditions

  • Gout
  • Hyperuricemia

Interventions

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

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

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-29
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04072471 on ClinicalTrials.gov