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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

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

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222512
Enrollment
Unknown
Registered
2014-06-04
Start date
2014-06-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout and Hyperuricemia

Interventions

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 ma

Sponsors

AstraZeneca
Lead Sponsor
Ardea Biosciences, Inc.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026