Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02078219 | Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia | PHASE2 | COMPLETED | 204 | — | — | Jan 5, 2014 | Mar 13, 2015 | Sep 24, 2019 | 14 | Japan |
The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group.
| Arm | Type | Description |
|---|---|---|
| RDEA3170 1 | EXPERIMENTAL | RDEA3170 5mg followed by RDEA3170 7.5mg |
| RDEA3170 2 | EXPERIMENTAL | RDEA3170 10mg followed by RDEA3170 12.5mg |
| RDEA3170 3 | EXPERIMENTAL | RDEA3170 12.5mg followed by RDEA3170 15mg |
| RDEA3170 4 | PLACEBO_COMPARATOR | RDEA3170 Placebo |
| Allopurinol | OTHER | Allopurinol 200mg |
| Name | Type | Description |
|---|---|---|
| RDEA3170 | DRUG | Oral Treatment |
| Allopurinol | DRUG | Oral Treatment |
| Placebo | DRUG | Oral Treatment |
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, diabe...