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NCT01493531 · ClinicalTrials.gov registry record · Phase 3

Combining Lesinurad With Allopurinol in Inadequate Responders

A Phase 3 study of Gout, sponsored by Ardea Biosciences.

Completed
Registry status
Phase 3
Development phase
610
Enrollment target
20
Study locations

NCT01493531: Completed Phase 3 study of Gout, sponsored by Ardea Biosciences.

NCT01493531 is a Phase 3 study of Gout that has completed, run by Ardea Biosciences. The registered enrollment target is 610 participants, below the 8,870-participant average among 34 other Gout trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01493531, a Phase 3 study of Gout, has completed, sponsored by Ardea Biosciences.

COMPLETED
Registry status
Phase 3
Development phase
610 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Proportion of subjects with an sUA level that is \< 6.0 mg/dL by Month 6.

Conditions Studied

Gout

Interventions

  • DRUG Placebo
  • DRUG Allopurinol
  • DRUG Lesinurad

Study Locations (20)

California

  • - Anaheim
  • - Gold River
  • - Irvine
  • - La Jolla
  • - Roseville
  • - San Diego
  • - San Diego
  • - San Ramon

Arizona

  • - Chandler
  • - Mesa
  • - Pheonix

Arkansas

  • - Jonesboro
  • - Jonesboro
  • - Little Rock

Colorado

  • - Colorado Springs
  • - Denver
  • - Glenwood Springs

Alabama

  • - Mobile

Connecticut

  • - Trumbull

District of Columbia

  • - Washington D.C.

Trial Details

FieldValue
Enrollment Target 610 participants
Start Date 2011-12
Est. Completion 2014-07
Phase Phase 3
Ardea Biosciences

32 total trials

What the finished NCT01493531 record still lists

NCT01493531 is an interventional study that assigns participants to a tested intervention. The registered 610 participants enrollment target is mid-sized for trials with a published cap, below the 8,870-participant average among 34 other Gout trials with a reported enrollment target (93% lower).

The record links to 1 condition, with Gout appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01493531 names 20 study sites across 7 states, led by California, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT01493531 about?

NCT01493531 is a clinical study titled "Combining Lesinurad With Allopurinol in Inadequate Responders". 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.

What is the current status of trial NCT01493531?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 610 participants. The study started on 2011-12. Estimated completion is 2014-07.

What conditions does trial NCT01493531 study?

This clinical trial studies the following conditions: Gout.

What interventions are being tested in trial NCT01493531?

The interventions under investigation include: Placebo (DRUG), Allopurinol (DRUG), Lesinurad (DRUG).

Who is sponsoring clinical trial NCT01493531?

This trial is sponsored by Ardea Biosciences, which has 32 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01493531 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Gout

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01493531's enrollment target sits among peer trials

610 6th of 34 higher than 29 of 34 other Gout trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Gout trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01493531, the US trial registry maintained by the National Library of Medicine. NCT01493531 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.