Lesinurad and Febuxostat Combination Extension Study in Gout

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01808144
First received: March 7, 2013
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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
Gout
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 ]

Other Outcome Measures:
  • Incidence of treatment emergent adverse events [ Time Frame: Up to approximately 2.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: March 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lesinurad 400 mg + febuxostat 80 mg 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808144

  Show 76 Study Locations
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
Study Director: C. Storgard, MD Ardea Biosciences, Inc.
  More Information

No publications provided

Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01808144     History of Changes
Other Study ID Numbers: RDEA594-307, 2012-004390-54
Study First Received: March 7, 2013
Last Updated: May 16, 2014
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

Keywords provided by Ardea Biosciences, Inc.:
Gout

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Febuxostat
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014