CompletedPhase 2

Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia

Japan204 participantsStarted 2014-01-05

Plain-language 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.

Who can participate

Age range20 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Percent Changes of Serum Uric Acid Levels From Baseline Levels

Timeframe: Baseline and Week 16

Trial details

NCT IDNCT02078219

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-03-13

Results submitted2017-07-19

View on ClinicalTrials.gov More Gout and Hyperuricemia trials