Lesinurad and Allopurinol Combination Extension Study in Gout

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01808131
First received: March 7, 2013
Last updated: July 11, 2016
Last verified: July 2016
  Purpose
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol 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 Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol

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 < 6.0 mg/dL [ Time Frame: up to a total of 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 ]

Enrollment: 717
Study Start Date: February 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lesinurad 200 mg + allopurinol Drug: Lesinurad
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.
Drug: Lesinurad
Tablets, 400 mg QD

Detailed Description:
This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with allopurinol in subjects who completed the double-blind treatment period in Studies RDEA594-301 and RDEA594-302.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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 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

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 ClinicalTrials.gov identifier: NCT01808131

  Show 208 Study Locations
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
Study Director: Maple Fung, MD Ardea Biosciences, Inc.
  More Information

Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01808131     History of Changes
Other Study ID Numbers: RDEA594-306  2012-004389-16 
Study First Received: March 7, 2013
Last Updated: July 11, 2016
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
New Zealand: Medsafe
Canada: Health Canada
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Australia: Department of Health and Ageing Therapeutic Goods Administration
South Africa: Medicines Control Council
Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad
Switzerland: Swissmedic
Ukraine: Ministry of Health

Keywords provided by Ardea Biosciences, Inc.:
Gout

Additional relevant MeSH terms:
Lesinurad
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs
Uricosuric Agents
Renal Agents

ClinicalTrials.gov processed this record on July 21, 2016