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

• Status: Completed
• Trial end date: 2015-03-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Ardea Biosciences, Inc.
• Treatments: Allopurinol; Verinurad

Criteria

Inclusion Criteria:

• Subject meets any of the following criteria and with sUA ≤10.0 mg/dL:

1. sUA level of >7.0 mg/dL at 7 days prior to baseline with gout;

2. sUA level of ≥8.0 mg/dL at 7 days prior to baseline without gout but with complications (hypertension, ischemic heart disease, diabetes, metabolic syndrome);

3. sUA level of ≥9.0 mg/dL at 7 days prior to baseline without gout and complications.

Exclusion Criteria:

• Subject with an acute gout flare that has not resolved at least 14 days prior to the baseline visit.

• Subject has a history or suspicion of kidney stones.

• Subject has an estimated creatinine clearance <60 mL/min calculated by the Cockcroft Gault formula

• Subject is receiving strong or moderate CYP3A inhibitors