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Open-Label Lesinurad Monotherapy Extension Study in Gout

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01650246
First Posted: July 26, 2012
Last Update Posted: May 26, 2016
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.
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
  Purpose
This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.

Condition Intervention Phase
Gout Drug: lesinurad Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects With Gout

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL [ Time Frame: Month 1 ]
  • Incidence of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 2 years ]

Enrollment: 143
Study Start Date: August 2012
Study Completion Date: August 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lesinurad 400 mg Drug: lesinurad
Tablets, 400 mg QD

Detailed Description:
This is a Phase 3, open-label, uncontrolled, extension study to assess the long-term efficacy and safety of lesinurad monotherapy in subjects who completed the double-blind treatment period in Study RDEA594-303.
  Eligibility

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 RDEA594-303 and was actively receiving and tolerating study medication (lesinurad or placebo) at Month 6 visit.
  • Subject is willing to adhere to the visit/protocol schedules.
  • 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 other 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.
  • Subject has a past medical history of urolithiasis, nephrolithiasis, or kidney stone diathesis.
  • Subject developed kidney stones during Study RDEA594-303
  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): NCT01650246


  Show 75 Study Locations
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
Study Director: Chris Storgard, MD Ardea Biosciences, Inc.
  More Information

Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01650246     History of Changes
Other Study ID Numbers: RDEA594-305
First Submitted: July 24, 2012
First Posted: July 26, 2012
Results First Submitted: January 14, 2016
Results First Posted: May 26, 2016
Last Update Posted: May 26, 2016
Last Verified: April 2016

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