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Lesinurad and Febuxostat Combination Extension Study in Gout

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ClinicalTrials.gov Identifier: NCT01808144
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.

Condition or disease Intervention/treatment Phase
Gout Drug: lesinurad Phase 3

Detailed Description:
This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with febuxostat in subjects who completed the double-blind treatment period in Study RDEA594-304.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2013
Primary Completion Date : August 2016
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gout
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Drug: lesinurad
Tablets, 400 mg once daily (QD)
Experimental: lesinurad 200 mg + febuxostat 80 mg Drug: lesinurad
Tablets, 200 mg QD


Outcome Measures

Primary Outcome Measures :
  1. Proportion of subjects with an sUA level that is < 5.0 mg/dL [ Time Frame: Up to approximately 2.5 years ]

Secondary Outcome Measures :
  1. Resolution of at least 1 target tophi [ Time Frame: Up to Month 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

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


  Show 72 Study Locations
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
Study Director: Nihar Bhakta, MD Ardea Biosciences, Inc.
More Information

Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01808144     History of Changes
Other Study ID Numbers: RDEA594-307
2012-004390-54 ( EudraCT Number )
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017

Keywords provided by Ardea Biosciences, Inc.:
Gout

Additional relevant MeSH terms:
Lesinurad
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Febuxostat
Gout Suppressants
Antirheumatic Agents
Uricosuric Agents
Renal Agents