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Combining Lesinurad With Allopurinol in Inadequate Responders (CLEAR 1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01510158
First received: January 11, 2012
Last updated: July 11, 2016
Last verified: July 2016
Results First Received: January 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Gout
Interventions: Drug: Lesinurad
Drug: Placebo
Drug: Allopurinol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lesinurad 200 mg + Allopurinol lesinurad 200 mg qd plus allopurinol
Lesinurad 400 mg + Allopurinol lesinurad 400 mg qd plus allopurinol
Placebo + Allopurinol placebo qd plus allopurinol

Participant Flow:   Overall Study
    Lesinurad 200 mg + Allopurinol     Lesinurad 400 mg + Allopurinol     Placebo + Allopurinol  
STARTED     202     203     202  
COMPLETED     151     150     152  
NOT COMPLETED     51     53     50  
Adverse Event                 7                 8                 5  
Gout flare                 1                 0                 0  
Protocol Violation                 17                 16                 24  
Sponsor terminated study.                 2                 0                 2  
Lost to Follow-up                 13                 16                 9  
Withdrawal by Subject                 10                 13                 10  
Death                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lesinurad 200 mg + Allopurinol lesinurad 200 mg qd plus allopurinol
Lesinurad 400 mg + Allopurinol lesinurad 400 mg qd plus allopurinol
Placebo + Allopurinol placebo qd plus allopurinol
Total Total of all reporting groups

Baseline Measures
    Lesinurad 200 mg + Allopurinol     Lesinurad 400 mg + Allopurinol     Placebo + Allopurinol     Total  
Number of Participants  
[units: participants]
  201     201     201     603  
Age  
[units: Years]
Mean (Standard Deviation)
  51.6  (10.7)     52.3  (11.5)     51.7  (11.7)     51.9  (11.3)  
Age, Customized  
[units: Participants]
       
<65     181     168     169     518  
>=65     20     33     32     85  
Gender  
[units: Participants]
       
Female     9     15     12     36  
Male     192     186     189     567  
Region of Enrollment  
[units: Participants]
       
United States     201     201     201     603  



  Outcome Measures
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1.  Primary:   Proportion of Subjects With an sUA Level That is < 6.0 mg/dL   [ Time Frame: 6 Months, analysis after all subjects complete 12 months ]

2.  Secondary:   Gout Flares   [ Time Frame: 12 Months ]

3.  Secondary:   Tophus   [ Time Frame: 12 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Nihar Bhakta, MD
Organization: Ardea Biosciences, MD
phone: 1-858-652-6671
e-mail: nbhakta@ardeabio.com



Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01510158     History of Changes
Other Study ID Numbers: RDEA594-301
Study First Received: January 11, 2012
Results First Received: January 21, 2016
Last Updated: July 11, 2016
Health Authority: United States: Food and Drug Administration