Lesinurad and Febuxostat Combination Extension Study in Gout
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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: NCT01808144 |
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Recruitment Status :
Completed
First Posted : March 11, 2013
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
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Sponsor:
Ardea Biosciences, Inc.
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Gout |
| Interventions |
Drug: lesinurad Drug: febuxostat |
| Enrollment | 196 |
Participant Flow
| Recruitment Details | Subjects entered this extension Study RDEA594-307 while the core Study RDEA594-304 was ongoing and the database was not yet locked. To maintain the blind of the core study for subjects entering the extension, the lesinurad dose for all subjects in this extension study was blinded to the Sponsor until database lock of Study RDEA594-304. |
| Pre-assignment Details | Subjects randomized to lesinurad (RDEA594) 200 mg or 400 mg + febuxostat (FBX) 80 mg in Study RDEA594-304 continued to receive the same dose in this study. Subjects randomized to placebo + febuxostat 80 mg in Study RDEA594-304 were randomized in a double-blind, 1:1 fashion to either lesinurad 200 mg or 400 mg + febuxostat 80 mg. |
| Arm/Group Title | Lesinurad 200 mg + Febuxostat 80 mg | Lesinurad 400 mg + Febuxostat 80 mg |
|---|---|---|
 Arm/Group Description |
[Not Specified] | [Not Specified] |
| Period Title: Overall Study | ||
| Started | 97 | 99 |
| Completed | 57 | 51 |
| Not Completed | 40 | 48 |
| Reason Not Completed | ||
| Death | 1 | 0 |
| Withdrawal by Subject | 16 | 23 |
| Lost to Follow-up | 6 | 3 |
| Protocol Violation | 6 | 6 |
| Gout flare | 0 | 1 |
| Adverse Event | 11 | 15 |
Baseline Characteristics
| Arm/Group Title | Lesinurad 400 mg + Febuxostat 80 mg | Lesinurad 200 mg + Febuxostat 80 mg | Total | |
|---|---|---|---|---|
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Arm/Group Description |
[Not Specified] | [Not Specified] | Total of all reporting groups | |
| Overall Number of Baseline Participants | 99 | 97 | 196 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 99 participants | 97 participants | 196 participants | |
| 52.1 (10.58) | 52.9 (10.24) | 52.5 (10.41) | ||
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Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 99 participants | 97 participants | 196 participants |
| < 65 years | 88 | 87 | 175 | |
| >=65 years | 11 | 10 | 21 | |
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Sex/Gender, Customized
Measure Type: Number Unit of measure: Participant |
Number Analyzed | 99 participants | 97 participants | 196 participants |
| Male | 7 | 1 | 8 | |
| Female | 92 | 96 | 188 | |
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 99 participants | 97 participants | 196 participants |
| United States | 72 | 72 | 144 | |
| Canada | 2 | 6 | 8 | |
| Poland | 12 | 13 | 25 | |
| Switzerland | 1 | 0 | 1 | |
| Australia | 5 | 3 | 8 | |
| New Zealand | 7 | 3 | 10 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
PI shall submit a copy of the Publication to Sponsor for review at least 45 days prior to its proposed submission. Sponsor reserves the right to delay any such publication for an additional period of 60 days. Upon Sponsor's request, PI agrees to delete from the proposed publication any Confidential Information. PI agrees not to release any publication without the prior written permission of Sponsor.
Results Point of Contact
| Name/Title: | Nihar Bhakta, MD |
| Organization: | Ardea Biosciences, Inc. |
| Phone: | 1-858-652-6671 |
| EMail: | nbhakta@ardeabio.com |
| Responsible Party: | Ardea Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT01808144 |
| Other Study ID Numbers: |
RDEA594-307 2012-004390-54 ( EudraCT Number ) |
| First Submitted: | March 7, 2013 |
| First Posted: | March 11, 2013 |
| Results First Submitted: | August 21, 2017 |
| Results First Posted: | January 30, 2018 |
| Last Update Posted: | January 30, 2018 |