Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia
NCT ID: NCT02078219
Last Updated: 2019-09-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
204 participants
INTERVENTIONAL
2014-01-05
2015-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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RDEA3170 1
RDEA3170 5mg followed by RDEA3170 7.5mg
RDEA3170
Oral Treatment
RDEA3170 2
RDEA3170 10mg followed by RDEA3170 12.5mg
RDEA3170
Oral Treatment
RDEA3170 3
RDEA3170 12.5mg followed by RDEA3170 15mg
RDEA3170
Oral Treatment
RDEA3170 4
RDEA3170 Placebo
Placebo
Oral Treatment
Allopurinol
Allopurinol 200mg
Allopurinol
Oral Treatment
Interventions
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RDEA3170
Oral Treatment
Allopurinol
Oral Treatment
Placebo
Oral Treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 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
20 Years
70 Years
ALL
No
Sponsors
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Ardea Biosciences, Inc.
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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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
Research Site
Sendai, , Japan
Research Site
Sendai, , Japan
Research Site
Sendai, , Japan
Research Site
Shinagawa-ku, , Japan
Countries
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Other Identifiers
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RDEA3170-203
Identifier Type: OTHER
Identifier Source: secondary_id
D5491C00001
Identifier Type: -
Identifier Source: org_study_id
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