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Lesinurad and Febuxostat Combination Extension Study in Gout

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Ardea Biosciences, Inc. Identifier:
First received: March 7, 2013
Last updated: August 30, 2016
Last verified: August 2016
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.

Condition Intervention Phase
Drug: lesinurad
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Ardea Biosciences, Inc.:

Primary Outcome Measures:
  • Proportion of subjects with an sUA level that is < 5.0 mg/dL [ Time Frame: Up to approximately 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Resolution of at least 1 target tophi [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2013
Estimated Study Completion Date: November 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01808144

  Show 72 Study Locations
Sponsors and Collaborators
Ardea Biosciences, Inc.
Study Director: M Fung, MD Ardea Biosciences, Inc.
  More Information

Responsible Party: Ardea Biosciences, Inc. Identifier: NCT01808144     History of Changes
Other Study ID Numbers: RDEA594-307  2012-004390-54 
Study First Received: March 7, 2013
Last Updated: August 30, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
New Zealand: Medsafe
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad
Switzerland: Swissmedic
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Ardea Biosciences, Inc.:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents processed this record on October 26, 2016