Lesinurad and Febuxostat Combination Extension Study in Gout
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|ClinicalTrials.gov Identifier: NCT01808144|
Recruitment Status : Completed
First Posted : March 11, 2013
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Gout||Drug: lesinurad Drug: febuxostat||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Long-Term Extension Study of Lesinurad in Combination With Febuxostat for Subjects With Gout Completing an Efficacy and Safety Study of Lesinurad and Febuxostat|
|Actual Study Start Date :||March 1, 2013|
|Actual Primary Completion Date :||August 9, 2016|
|Actual Study Completion Date :||October 6, 2016|
Experimental: lesinurad 400 mg + febuxostat 80 mg
Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015.
Tablets, 400 mg once daily (QD)
Tabletsm 80 mg QD
|Experimental: lesinurad 200 mg + febuxostat 80 mg||
Tablets, 200 mg QD
Tabletsm 80 mg QD
- Percentage of Participants With an sUA Level That is < 5.0 mg/dL [ Time Frame: Up to approximately 2.5 years (at Extension Month 12) ]Percentage of participants in Study 307 With sUA < 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases
- Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus [ Time Frame: Up to approximatley 2.5 years (at Extension Month 12) ]Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases)
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|Ages Eligible for Study:||18 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
- Subject completed the double-blind treatment period in Study RDEA594-304 and was actively receiving and tolerating study medication (lesinurad or placebo) and febuxostat 80 mg at the Month 12 visit.
- Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication.
- Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808144
|Study Director:||Nihar Bhakta, MD||Ardea Biosciences, Inc.|
|Responsible Party:||Ardea Biosciences, Inc.|
|Other Study ID Numbers:||
2012-004390-54 ( EudraCT Number )
|First Posted:||March 11, 2013 Key Record Dates|
|Results First Posted:||January 30, 2018|
|Last Update Posted:||January 30, 2018|
|Last Verified:||January 2018|
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