At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 204 enrolled
Drug / intervention
RDEA3170 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, 24-Week Phase II Study to Evaluate Efficacy and Safety of RDEA3170 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg Versus Placebo and Open-Label Allopurinol 200 mg as a Reference Arm in Japanese Patients With Gout or Asymptomatic Hyperuricemia
In Brief
A Phase 2 clinical trial evaluating RDEA3170, Allopurinol, and 1 other intervention for Gout and Hyperuricemia. Completed, enrolled 204 participants across 14 sites.
Detailed Summary
This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg once daily, respectively will result in greater reduction of sUA compared to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout and Hyperuricemia
CountriesJapan
CollaboratorsArdea Biosciences, Inc.
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJan 2014
First PostedMar 2014
Primary CompletionMar 2015
TodayJul 2026
First PostedMar 5, 2014
Enrollment StartJan 5, 2014
Primary CompletionMar 13, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.3 years ago
Interventions
RDEA3170drug
Oral Treatment
Allopurinoldrug
Oral Treatment
Placebodrug
Oral Treatment