Clinical Trial: Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 an
Brief 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.
Detailed Summary:
Sponsor: AstraZeneca
Current Primary Outcome: Percent changes of serum uric acid levels from baseline levels [ Time Frame: After 16 weeks of treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of subjects with a serum uric acid level ≤6.0 mg/dL [ Time Frame: Every 1 to 4 weeks, up to 16 weeks ]To compare the proportion of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit
- Serum uric acid levels [ Time Frame: Every 1 to 4 weeks, up to 16 weeks ]To compare serum uric acid levels at each study visit
- Absolute change of serum uric acid levels from baseline levels [ Time Frame: Every 1 to 4 weeks, up to 16 weeks ]To compare the absolute change of serum uric acid levels from baseline levels
- Percent change of serum uric acid levels from baseline [ Time Frame: Every 1 to 4 weeks, up to 16 weeks ]To compare percent change of serum uric acid levels from baseline levels
- Adverse Events, laboratory tests, vital signs, electrocardiograms, gout flare and pain assessment [ Time Frame: Every 1 to 4 weeks, up to 18 weeks ]To evaluate the safety and tolerability of RDEA3170 in patients with gout or asymptomatic hyperuricemia
Original Secondary Outcome:
- Proportion of subjects with a serum uric acid level ?6.0 mg/dL [ Time Frame: Every 1 to 4 weeks, up to 16 weeks ]To compare the proportion of subjects whose serum uric acid levels are ? 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit
- Serum uric acid levels [ Time Frame: Every 1 to 4 weeks, up to 16 weeks ]To compare serum uric acid levels at each study visit
- Absolute change of serum uric acid levels from baseline levels [ Time Frame: Every 1 to 4 weeks, up to 16 weeks ]To compare the absolute change of serum uric acid levels from baseline levels
- Percent change of serum uric acid levels from baseline [ Time Frame: Every 1 to 4 weeks, up to 16 weeks ]To compare percent change of serum uric acid levels from baseline levels
- Adverse Events, laboratory tests, vital signs, electrocardiograms, gout flare and pain assessment [ Time Frame: Every 1 to 4 weeks, up to 18 weeks ]To evaluate the safety and tolerability of RDEA3170 in patients with gout or asymptomatic hyperuricemia
Information By: AstraZeneca
Dates:
Date Received: February 26, 2014
Date Started: January 2014
Date Completion:
Last Updated: March 25, 2015
Last Verified: March 2015