Clinical trial NCT02078219: Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout and Hyperuricemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Ardea Biosciences, Inc.
First posted: 2014-03-05
Enrollment: 204
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Changes of Serum Uric Acid Levels From Baseline Levels
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
timeFrame: Weeks 1,2,4,6,8,10,12,16,18,20,24
measure: Percent Change in sUA
timeFrame: Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24
measure: Absolute Change of Serum Uric Acid Levels From Baseline Levels
timeFrame: Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24
Other outcomes:
Locations:
city: Chofu-shi
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Kitakyushu-shi
country: Japan
facility: Research Site
city: Matsudo-shi
country: Japan
facility: Research Site
city: Noda-shi
country: Japan
facility: Research Site
city: Ota-ku
country: Japan
facility: Research Site
city: Saitama-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Shinagawa-ku
country: Japan
facility: Research Site
Study officials:
References: