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 ]

The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group.


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