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

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.

Timeline

Start

2014-01-05

Primary completion

2015-03-13

Completion

2015-03-13

Outcome

Met primary endpoint

registry RDEA3170 Treatment Group 1 vs RDEA3170 Placebo Treatment Group; p <0.0001; Mean Difference (Final Values) -29.28 NCT02078219 ↗

registry RDEA3170 Treatment Group 2 vs RDEA3170 Placebo Treatment Group; p <0.0001; Mean Difference (Final Values) -49.25 NCT02078219 ↗

registry RDEA3170 Treatment Group 3 vs RDEA3170 Placebo Treatment Group; p <0.0001; Mean Difference (Final Values) -53.33 NCT02078219 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Allopurinol	Small molecule	200 mg	Oral
Subject	Verinurad	Small molecule	7.5 mg	Oral
Subject	Verinurad	Small molecule	12.5 mg	Oral
Subject	Verinurad	Small molecule	15 mg	Oral

Indications