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

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2014
INTERVENTION: investigational material(s) Generic name etc : RDEA3170 INN of investigational material : Therapeutic category code : 394 Agents for treatment of gout Dosage and Administration for Investigational material : RDEA3170 5mg followed by RDEA3170 7.5mg, RDEA3170 10mg followed by RDEA3170 12.5mg, RDEA3170 12.5mg followed by RDEA3170 15mg control material(s) Generic name etc : Placebo, Allopurinol INN of investigational material : Therapeutic category code : ‐‐‐ Other Dosage and Administration for Investigational material : RDEA3170 Placebo, Allopurinol 200mg CONDITION: Gout and Hyperuricemia 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.
Epistemonikos ID: ab4c421904dc1aae4cd425f9bff77c2a6cda0aaa
First added on: Aug 26, 2024