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Trial · NCT01510158

Combining Lesinurad With Allopurinol in Inadequate Responders

NCT01510158, Phase 3, Completed, Ardea Biosciences, Inc.; results first posted 2016-08-18

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Combining Lesinurad With Allopurinol in Inadequate Responders. Trials, record NCT01510158. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01510158

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Combining Lesinurad With Allopurinol in Inadequate Responders
NCT number
NCT01510158
Status
Completed
Phases
Phase 3
Enrollment
607 participants, actual
Lead sponsor
Ardea Biosciences, Inc.
Conditions
Gout
Interventions
Lesinurad, Lesinurad, Placebo, Allopurinol, Allopurinol, Allopurinol
First posted
2012-01-13
Last updated
2016-08-18
Results first posted
2016-08-18

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryProportion of Subjects With an sUA Level That is < 6.0 mg/dL6 Months, analysis after all subjects complete 12 months
SecondaryGout Flares12 MonthsMean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12
SecondaryTophus12 MonthsProportion of subjects with ≥ 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYProportion of Subjects With an sUA Level That is < 6.0 mg/dL6 Months, analysis after all subjects complete 12 monthsIntent-to-Treat PopulationProportion of SubjectsNUMBER
SECONDARYGout Flares12 MonthsGout FlaresMEAN
SECONDARYTophus12 MonthsProportion of SubjectsNUMBER

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Proportion of Subjects With an sUA Level That is < 6.0 mg/dLLesinurad 200 mg + Allopurinol0.542Proportion of Subjects
Proportion of Subjects With an sUA Level That is < 6.0 mg/dLLesinurad 400 mg + Allopurinol0.592Proportion of Subjects
Proportion of Subjects With an sUA Level That is < 6.0 mg/dLPlacebo + Allopurinol0.279Proportion of Subjects
Gout FlaresLesinurad 200 mg + Allopurinol.60Standard Deviation 1.2Gout Flares
Gout FlaresLesinurad 400 mg + Allopurinol.50Standard Deviation 1.2Gout Flares
Gout FlaresPlacebo + Allopurinol.60Standard Deviation 1.3Gout Flares
TophusLesinurad 200 mg + Allopurinol0Proportion of Subjects
TophusLesinurad 400 mg + Allopurinol0.211Proportion of Subjects
TophusPlacebo + Allopurinol0.294Proportion of Subjects

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDLesinurad 200 mg + Allopurinol202
Overall StudySTARTEDLesinurad 400 mg + Allopurinol203
Overall StudySTARTEDPlacebo + Allopurinol202
Overall StudyCOMPLETEDLesinurad 200 mg + Allopurinol151
Overall StudyCOMPLETEDLesinurad 400 mg + Allopurinol150
Overall StudyCOMPLETEDPlacebo + Allopurinol152
Overall StudyNOT COMPLETEDLesinurad 200 mg + Allopurinol51
Overall StudyNOT COMPLETEDLesinurad 400 mg + Allopurinol53
Overall StudyNOT COMPLETEDPlacebo + Allopurinol50

Source ClinicalTrials.gov

Adverse events1,350

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAnaemiaBlood and lymphatic system disordersLesinurad 200 mg + Allopurinol02010
otherAnaemiaBlood and lymphatic system disordersLesinurad 400 mg + Allopurinol32013
otherAnaemiaBlood and lymphatic system disordersPlacebo + Allopurinol12011
otherLeukocytosisBlood and lymphatic system disordersLesinurad 200 mg + Allopurinol12011
otherLeukocytosisBlood and lymphatic system disordersLesinurad 400 mg + Allopurinol02010
otherLeukocytosisBlood and lymphatic system disordersPlacebo + Allopurinol02010
otherThrombocytopeniaBlood and lymphatic system disordersLesinurad 200 mg + Allopurinol12011
otherThrombocytopeniaBlood and lymphatic system disordersLesinurad 400 mg + Allopurinol02010
otherThrombocytopeniaBlood and lymphatic system disordersPlacebo + Allopurinol02010
otherThrombocytosisBlood and lymphatic system disordersLesinurad 200 mg + Allopurinol02010

1 to 10 of 1,350Source ClinicalTrials.gov

See all 1,350 adverse events

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityLesinurad 200 mg + Allopurinol
Total, all-cause mortalityLesinurad 400 mg + Allopurinol
Total, all-cause mortalityPlacebo + Allopurinol
Total, other adverse eventsLesinurad 200 mg + Allopurinol147201
Total, other adverse eventsLesinurad 400 mg + Allopurinol156201
Total, other adverse eventsPlacebo + Allopurinol138201
Total, serious adverse eventsLesinurad 200 mg + Allopurinol9201
Total, serious adverse eventsLesinurad 400 mg + Allopurinol16201
Total, serious adverse eventsPlacebo + Allopurinol11201

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
27564409DERIVEDPubMed
35835008DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01510158

GET https://conductscience.org/api/trials/v1/NCT01510158/events?page=2

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