NCT02078219

Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gout and Hyperuricemia

Interventions

Type	Name	Description
DRUG	RDEA3170	Oral Treatment
DRUG	Allopurinol	Oral Treatment
DRUG	Placebo	Oral Treatment

Timeline

• Start date: 2014-01-05
• Primary completion: 2015-03-13
• Completion: 2015-03-13
• First posted: 2014-03-05
• Last updated: 2019-09-24
• Results posted: 2019-09-24

Locations

14 sites across 1 country: Japan