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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 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.

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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.

Conditions Studied

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

Sponsor

Ardea Biosciences

32 total trials

What the Registry Record Tells You About NCT01493531

The ClinicalTrials.gov registry entry for NCT01493531 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 610 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 8,870-participant average among 34 other Gout trials with a reported enrollment target (93% lower). The listed sponsor is Ardea Biosciences, which has 32 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.