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Open-Label Lesinurad Monotherapy Extension Study in Gout

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01650246
First received: July 24, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Gout
U.S. FDA Resources

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 approximately 2 years ] [ Designated as safety issue: No ]
  • Incidence of TEAEs [ Time Frame: Up to approximately 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: August 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (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

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 RDEA594-303 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650246

  Show 57 Study Locations
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
Study Director: Scott Baumgartner, MD Ardea Biosciences, Inc.
  More Information

No publications provided

Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01650246     History of Changes
Other Study ID Numbers: RDEA594-305
Study First Received: July 24, 2012
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
New Zealand: Medsafe
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on May 19, 2013