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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;   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
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

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 
Overall Participants Analyzed 
[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