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

Phase 2

Completed

• Conditions: Gout and Hyperuricemia
• Interventions: Drug: RDEA3170; Drug: Placebo; Drug: Allopurinol

• Registration Number: NCT02078219
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-05
• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Primary Completion: 2015-03-13
• Study Completion: 2015-03-13
• Results First Submitted: 2017-07-19
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-21
• Last Update Submitted: 2019-08-21
• Results First Posted: 2019-09-24
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RDEA3170 1	RDEA3170	RDEA3170 5mg followed by RDEA3170 7.5mg
RDEA3170 3	RDEA3170	RDEA3170 12.5mg followed by RDEA3170 15mg
RDEA3170 4	Placebo	RDEA3170 Placebo
RDEA3170 2	RDEA3170	RDEA3170 10mg followed by RDEA3170 12.5mg
Allopurinol	Allopurinol	Allopurinol 200mg

Primary Outcome Measures

Name	Time	Method
Percent Changes of Serum Uric Acid Levels From Baseline Levels	Baseline and Week 16	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL	Weeks 1,2,4,6,8,10,12,16,18,20,24	To compare the percentage of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit
Absolute Change of Serum Uric Acid Levels From Baseline Levels	Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24	To compare the absolute change of serum uric acid levels from baseline levels
Percent Change in sUA	Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24	To compare percent change in sUA at each study visit.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Shinagawa-ku, Japan