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Combining Lesinurad With Allopurinol in Inadequate Responders

NCT01493531 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 610

Last updated 2016-05-26

Study results available
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Summary

This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who have had an inadequate response to allopurinol.

Conditions

Interventions

DRUG

Lesinurad

Tablets, 200 mg QD

DRUG

Lesinurad

Tablets, 400 mg QD

DRUG

Placebo

Tablets, Placebo QD

DRUG

Allopurinol

Tablets

Sponsors & Collaborators

  • Ardea Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Chris Storgard, MD · Ardea Biosciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-05-31
Completion
2014-07-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Germany
  • New Zealand
  • Poland
  • South Africa
  • Spain
  • Switzerland
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT01493531 on ClinicalTrials.gov