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Allopurinol Combination Study

NCT01001338 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2017-01-24

No results posted yet for this study

Summary

To compare the proportion of subjects whose serum urate (sUA) levels are \< 6.0 mg/dL following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate hypouricemic response with standard doses of allopurinol.

Conditions

Interventions

DRUG

RDEA594

Uricosuric agent for the treatment of gout.

DRUG

Placebo

Matching Placebo

DRUG

Allopurinol

Allopurinol

Sponsors & Collaborators

  • Ardea Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Nihar Bhakta, MD · Ardea Biosciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-01-31
Completion
2016-08-31

Countries

  • United States
  • Canada
  • Poland
  • Spain
  • Ukraine
  • United Kingdom

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 NCT01001338 on ClinicalTrials.gov