Lesinurad and Allopurinol Combination Extension Study in Gout
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01808131|
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : January 24, 2017
- Study Details
- Tabular View
- Results Submitted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Gout||Drug: Lesinurad||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||717 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||November 2016|
|Experimental: lesinurad 200 mg + allopurinol||
Tablets, 200 mg QD
Experimental: lesinurad 400 mg + allopurinol
Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015.
Tablets, 400 mg QD
- Proportion of subjects with an sUA level that is < 6.0 mg/dL [ Time Frame: up to a total of 5 years ]
- Resolution of at least 1 target tophi [ Time Frame: Up to Month 12 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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 either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol 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
- 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): NCT01808131
|Study Director:||Nihar Bhakta, MD||Ardea Biosciences, Inc.|
|Responsible Party:||Ardea Biosciences, Inc.|
|Other Study ID Numbers:||
2012-004389-16 ( EudraCT Number )
|First Posted:||March 11, 2013 Key Record Dates|
|Last Update Posted:||January 24, 2017|
|Last Verified:||January 2017|
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn