MedTrace Logo

Combining Lesinurad With Allopurinol in Inadequate Responders

NCT01510158 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 607

Last updated 2016-08-18

Study results available
· View outcomes & findings →

Summary

This study that 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 once daily (qd)

DRUG

Lesinurad

Tablets, 400 mg qd

DRUG

Placebo

Tablets, Placebo qd

DRUG

Allopurinol

Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)

DRUG

Allopurinol

Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)

DRUG

Allopurinol

Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)

Sponsors & Collaborators

  • Ardea Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Chris Storgard, 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
2012-01-31
Primary Completion
2014-07-31
Completion
2014-08-31

Countries

  • United States

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 NCT01510158 on ClinicalTrials.gov