Phase 2
N=204
Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia
Gout and Hyperuricemia
Bottom Line
View on ClinicalTrials.gov: NCT02078219 ↗Enrolled (actual)
204
Serious AEs
2.0%
Results posted
Sep 2019
Primary outcome: Primary: Percent Changes of Serum Uric Acid Levels From Baseline Levels — -30.93; -49.91; -54.32; -2.05 Percent change — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RDEA3170 (Drug); Allopurinol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Changes of Serum Uric Acid Levels From Baseline Levels |
-30.93; -49.91; -54.32; -2.05; -39.09 | <0.0001 sig |
| SECONDARY Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL |
26.8; 31.7; 39.0; 0; 19.5; 29.3 | — |
| SECONDARY Percent Change in sUA |
-19.72; -20.29; -19.93; -0.25; -20.74; -21.03 | — |
| SECONDARY Absolute Change of Serum Uric Acid Levels From Baseline Levels |
-1.68; -1.74; -1.68; -0.05; -1.82; -1.81 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subject meets any of the following criteria and with sUA ≤10.0 mg/dL:
- sUA level of >7.0 mg/dL at 7 days prior to baseline with gout;
- 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);
- 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
Data sourced from ClinicalTrials.gov (NCT02078219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.