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Lesinurad and Allopurinol Combination Extension Study in Gout

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.
 
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.

Tracking Information
First Submitted Date  ICMJE March 7, 2013
First Posted Date  ICMJE March 11, 2013
Last Update Posted Date January 24, 2017
Study Start Date  ICMJE February 2013
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
Proportion of subjects with an sUA level that is < 6.0 mg/dL [ Time Frame: up to a total of 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 8, 2013)
Proportion of subjects with an sUA level that is < 6.0 mg/dL [ Time Frame: Up to approximately 2.5 years ]
Change History Complete list of historical versions of study NCT01808131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2013)
Resolution of at least 1 target tophi [ Time Frame: Up to Month 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 8, 2013)
Incidence of treatment emergent adverse events [ Time Frame: Up to approximately 2.5 years ]
 
Descriptive Information
Brief Title  ICMJE Lesinurad and Allopurinol Combination Extension Study in Gout
Official Title  ICMJE A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gout
Intervention  ICMJE
  • Drug: Lesinurad
    Tablets, 200 mg QD
  • Drug: Lesinurad
    Tablets, 400 mg QD
Study Arms  ICMJE
  • Experimental: lesinurad 200 mg + allopurinol
    Intervention: Drug: Lesinurad
  • 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.
    Intervention: Drug: Lesinurad
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2016)
717
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2013)
800
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Germany,   New Zealand,   Poland,   South Africa,   Spain,   Switzerland,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01808131
Other Study ID Numbers  ICMJE RDEA594-306
2012-004389-16 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ardea Biosciences, Inc.
Study Sponsor  ICMJE Ardea Biosciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nihar Bhakta, MD Ardea Biosciences, Inc.
PRS Account Ardea Biosciences, Inc.
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP