RDEA3170 Monotherapy in Subjects With Gout
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|ClinicalTrials.gov Identifier: NCT01927198|
Recruitment Status : Completed
First Posted : August 22, 2013
Last Update Posted : July 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gout||Drug: Placebo Drug: RDEA3170 5 mg Drug: RDEA3170 10 mg Drug: RDEA3170 12.5 mg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RDEA3170 Monotherapy in Subjects With Gout|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||July 2014|
Experimental: RDEA3170 5 mg qd
|Drug: RDEA3170 5 mg|
Experimental: RDEA3170 10 mg qd
Increase from RDEA3170 5 mg to RDEA3170 10 mg qd at Week 2.
|Drug: RDEA3170 10 mg|
Experimental: RDEA3170 12.5 mg qd
Increase from RDEA3170 10 mg to RDEA3170 12.5 mg qd at Week 4.
|Drug: RDEA3170 12.5 mg|
Placebo Comparator: Placebo
- Efficacy of RDEA3170 monotherapy at Week 12 [ Time Frame: Week 12 ]Percent change from baseline in serum urate levels at Week 12.
- Incidence of treatment-emergent adverse events and change from baseline in laboratory values, vital signs, and electrocardiograms [ Time Frame: 8 months ]Safety assessments include adverse event (AE) recording, gout flare recording, clinical safety laboratory tests (eg, hematology, serum chemistry, and urinalysis), physical examinations, vital sign measurements, and ECGs.
- Efficacy of RDEA3170 monotherapy at Week 24 [ Time Frame: Week 24 ]Percent change from baseline in serum urate levels at each visit. Proportion of subjects with a serum urate level < 6.0 and < 5.0 mg/dL at each visit.
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): NCT01927198
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|Study Director:||J. Hall, MD||Ardea Biosciences, Inc.|