A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, 24-Week Phase 2 Study to Evaluate Efficacy and Safety of RDEA3170 5mg, 7.5mg, 10mg, 12.5mg and 15mg Versus Placebo and Open-Label Allopurinol 200mg as a Reference Arm in Japanese Patients With Gout or Asymptomatic Hyperuricemia
Phase 2
- Conditions
- Gout and Hyperuricemia
- Registration Number
- JPRN-jRCT2080222512
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Subject meets any of the following criteria and with sUA 10.0 mg/dL or more:
a. sUA level of >7.0 mg/dL at 7 days prior to baseline with gout;
b. sUA level of 8.0 mg/dL or more at 7 days prior to baseline without gout but with complications (hypertension, ischemic heart disease, diabetes, metabolic syndrome);
c. sUA level of 9.0 mg/dL or more 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method