Phase 3 Gout Trial, Completed NCT01650246 Sponsor: Ardea Biosciences, Inc. Condition: Gout
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 143 participants, all of whom received lesinurad 400 mg. The trial was measuring two things: how many participants had their blood uric acid level drop below a certain threshold (6.0 mg/dL, a level often used as a treatment target in gout management), and how many unwanted medical events occurred during the study period. It is worth noting that the data shows zero participants were recorded as having "completed" the study, with all 143 listed as "not completed" — the reasons for this were not reported in the submitted data. The reported data shows that out of the 143 participants, 68 had a blood uric acid level below 6.0 mg/dL during the study. Separately, 105 treatment-emergent adverse events (that is, unwanted medical occurrences that happened after starting the study medication) were recorded across the group. No further breakdown of those adverse events — such as what types occurred or how serious they were — was included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Gout Trial, Completed

NCT01650246
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are able to understand what the study involves and the possible risks, and you are willing to sign a consent form before any study activities begin.
  • You took part in and completed a previous related study (called RDEA594-303) and were still actively taking the study medication (either lesinurad or a dummy pill) at the 6-month visit in that study.
  • You are willing to follow the study schedule and attend all required visits.
  • You are male or female; however, if you are a woman who could become pregnant, you must agree to use an effective non-hormonal form of birth control throughout the study and for at least 14 days after taking your last dose of study medication.

Who may not be able to join:

  • You have any other medical or mental health condition that the study doctor believes could put you at unnecessary risk or make it difficult for you to follow the study rules and complete the study (confirm with trial site).
  • You have a past history of kidney stones or a condition that makes you prone to developing kidney stones.
  • You developed kidney stones while taking part in the previous related study (RDEA594-303).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Chris Storgard, MD, Ardea Biosciences, Inc.

Australian sites

, Herston, Queensland
, Hobart, Tasmania

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Ardea Biosciences, Inc.
Registry
ClinicalTrials.gov
Start date
1 August 2012
Est. completion
1 April 2014

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇩🇪 Germany 🇳🇿 New Zealand 🇿🇦 South Africa 🇺🇸 United States

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL; Incidence of Treatment-emergent Adverse Events (TEAEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov