Lesinurad and Febuxostat Combination Extension Study in Gout

NCT01808144 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2018-01-30

Study results available
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Summary

This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.

Conditions

Interventions

DRUG

lesinurad

Tablets, 400 mg once daily (QD)

DRUG

lesinurad

Tablets, 200 mg QD

DRUG

febuxostat

Tabletsm 80 mg QD

Sponsors & Collaborators

  • Ardea Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Nihar Bhakta, MD · Ardea Biosciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-01
Primary Completion
2016-08-09
Completion
2016-10-06

Countries

  • United States
  • Australia
  • Canada
  • New Zealand
  • Poland
  • Switzerland

Study Locations

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Entities

Diseases

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 NCT01808144 on ClinicalTrials.gov