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

Gout and Hyperuricemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078219
• Other study ID #: D5491C00001
• Secondary ID: RDEA3170-203
• Status: Completed
• Phase: Phase 2
• Start date: January 5, 2014
• Est. completion date: March 13, 2015

Study information

• Verified date: August 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: March 13, 2015
• Est. primary completion date: March 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gout
• Gout and Hyperuricemia
• Hyperuricemia

Intervention

Drug:
• RDEA3170
Oral Treatment
• Allopurinol
Oral Treatment
• Placebo
Oral Treatment

Locations

Country	Name	City	State
Japan	Research Site	Chofu-shi
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Kitakyushu-shi
Japan	Research Site	Matsudo-shi
Japan	Research Site	Noda-shi
Japan	Research Site	Ota-ku
Japan	Research Site	Saitama-shi
Japan	Research Site	Sendai-shi
Japan	Research Site	Sendai-shi
Japan	Research Site	Sendai-shi
Japan	Research Site	Sendai-shi
Japan	Research Site	Shinagawa-ku

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Ardea Biosciences, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Changes of Serum Uric Acid Levels From Baseline Levels	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.	Baseline and Week 16
Secondary	Percentage of Subjects With a Serum Uric Acid Level =6.0 mg/dL	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	Weeks 1,2,4,6,8,10,12,16,18,20,24
Secondary	Percent Change in sUA	To compare percent change in sUA at each study visit.	Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24
Secondary	Absolute Change of Serum Uric Acid Levels From Baseline Levels	To compare the absolute change of serum uric acid levels from baseline levels	Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24