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Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia | Clinical Trials | Clareo Health

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

A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, 24-Week Phase II Study to Evaluate Efficacy and Safety of RDEA3170 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg Versus Placebo and Open-Label Allopurinol 200 mg as a Reference Arm in Japanese Patients With Gout or Asymptomatic Hyperuricemia

NCT02078219•AstraZeneca

View on ClinicalTrials.gov

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

Age

20 - 70 years

Sex

ALL

Healthy Volunteers

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, diabetes, metabolic syndrome);
•3. 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

Locations (14)

Research Site

Chofu-shi, Japan

Research Site

Fukuoka, Japan

Research Site

Fukuoka, Japan

Research Site

Fukuoka, Japan

Research Site

Kitakyushu-shi, Japan

Research Site

Matsudo-shi, Japan

Research Site

Noda, Japan

Research Site

Ōta-ku, Japan

Research Site

Saitama-shi, Japan

Research Site

Sendai, Japan

Key Dates

Start Date

January 5, 2014

Primary Completion Date

March 13, 2015

Completion Date

March 13, 2015

Last Updated

September 24, 2019

Enrollment

204

ACTUAL participants

Conditions

Gout and Hyperuricemia

Interventions

RDEA3170

DRUG

Allopurinol

DRUG

Placebo

DRUG

PK Effects of SHR4640 on Repaglinide and Midazolam, and the Impact of SHR4640 on QT Interval

NCT06196580

Gout and Hyperuricemia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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