Trial · NCT01508702

Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors

NCT01508702, Phase 3, Completed, Ardea Biosciences, Inc.; results first posted 2016-02-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors. Trials, record NCT01508702. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01508702

On this page

Trial

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

Title: Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors
NCT number: NCT01508702
Status: Completed
Phases: Phase 3
Enrollment: 214 participants, actual
Lead sponsor: Ardea Biosciences, Inc.
Conditions: Gout
Interventions: lesinurad, Placebo
First posted: 2012-01-12
Last updated: 2016-02-12
Other registries' IDs: eudract:2011-003756-39
Results first posted: 2016-02-12

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Number of Subjects With an sUA Level That is < 6.0 mg/dL	6 months

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects With an sUA Level That is < 6.0 mg/dL	6 months	ITT Population	Number of Subjects	NUMBER

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Number of Subjects With an sUA Level That is < 6.0 mg/dL	Lesinurad 400 mg		32		Number of Subjects
Number of Subjects With an sUA Level That is < 6.0 mg/dL	Placebo		2		Number of Subjects

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Lesinurad 400 mg	107
Overall Study	STARTED	Placebo	107
Overall Study	COMPLETED	Lesinurad 400 mg	84
Overall Study	COMPLETED	Placebo	94
Overall Study	NOT COMPLETED	Lesinurad 400 mg	23
Overall Study	NOT COMPLETED	Placebo	13

Source ClinicalTrials.gov

Adverse events42

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

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	Lesinurad 400 mg	6	107	6
other	Constipation	Gastrointestinal disorders	Placebo	0	107	0
other	Diarrhoea	Gastrointestinal disorders	Lesinurad 400 mg	10	107	10
other	Diarrhoea	Gastrointestinal disorders	Placebo	6	107	6
other	Oedema peripheral	General disorders	Lesinurad 400 mg	3	107	4
other	Oedema peripheral	General disorders	Placebo	0	107	0
other	Pyrexia	General disorders	Lesinurad 400 mg	3	107	3
other	Pyrexia	General disorders	Placebo	0	107	0
other	Bronchitis	Infections and infestations	Lesinurad 400 mg	5	107	5
other	Bronchitis	Infections and infestations	Placebo	2	107	2

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lesinurad 400 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Lesinurad 400 mg	39	107
Total, other adverse events	Placebo	8	107
Total, serious adverse events	Lesinurad 400 mg	9	107
Total, serious adverse events	Placebo	4	107

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29029210	DERIVED	PubMed
35835008	DERIVED	PubMed

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 comparisons1

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

Comparison
Lesinurad 400 mg vs Placebo: serious adverse events

Source Trial comparisons

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.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license 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.

For software

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/NCT01508702

GET https://conductscience.org/api/trials/v1/NCT01508702/events?page=2

API reference For AI assistants