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Lesinurad and Allopurinol Combination Extension Study in Gout

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ClinicalTrials.gov Identifier: NCT01808131
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Study Description
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Brief Summary:
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.

Condition or disease Intervention/treatment Phase
Gout Drug: Lesinurad Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 717 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects with an sUA level that is < 6.0 mg/dL [ Time Frame: up to a total of 5 years ]

Secondary Outcome Measures :
  1. Resolution of at least 1 target tophi [ Time Frame: Up to Month 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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 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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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): NCT01808131


Locations
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Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
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Study Director: Nihar Bhakta, MD Ardea Biosciences, Inc.
More Information
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Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01808131    
Other Study ID Numbers: RDEA594-306
2012-004389-16 ( EudraCT Number )
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Keywords provided by Ardea Biosciences, Inc.:
Gout
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
 Genetic Diseases, Inborn
Metabolic Diseases
Lesinurad
Gout Suppressants
Antirheumatic Agents
Uricosuric Agents
Renal Agents