Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
172 participants
INTERVENTIONAL
2013-08-31
2014-07-31
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
DOUBLE
Study Groups
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RDEA3170 5 mg qd
No titration.
RDEA3170 5 mg
RDEA3170 10 mg qd
Increase from RDEA3170 5 mg to RDEA3170 10 mg qd at Week 2.
RDEA3170 10 mg
RDEA3170 12.5 mg qd
Increase from RDEA3170 10 mg to RDEA3170 12.5 mg qd at Week 4.
RDEA3170 12.5 mg
Placebo
Placebo group
Placebo
Interventions
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Placebo
RDEA3170 5 mg
RDEA3170 10 mg
RDEA3170 12.5 mg
Eligibility Criteria
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Inclusion Criteria
* Subject has a serum urate level ≥ 6.5 mg/dL and ≤ 10.0 mg/dL during the Screening Period.
* Subject has a body mass index \< 40 kg/m2.
Exclusion Criteria
* Subject has a history or suspicion of kidney stones.
* Subject has a history or suspicion of drug abuse within the past 5 years.
* Subject has a history of symptomatic myositis/myopathy or rhabdomyolysis.
* Subject has a known or suspected human immunodeficiency virus infection.
* Subject has a positive test for active hepatitis B or hepatitis C infection.
* Subject has a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia, or treated in situ Grade 1 cervical cancer.
* Subject within the last 12 months with: unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis; or subjects currently receiving anticoagulants.
* Subject has a QT interval corrected for heart rate according to Fridericia's formula \> 450 msec during the Screening Period, confirmed by a repeat assessment.
* Subject has uncontrolled hypertension.
* Subject has an estimated creatinine clearance \< 60 mL/min.
* Subject has an alkaline phosphatase \> 2.0 x upper limit of normal during the Screening Period.
* Subject has active liver disease or impaired hepatic function.
* Subject is receiving chronic treatment with more than 325 mg salicylates per day.
* Subject has a medical condition that requires or may require systemic immunosuppressive (eg, chronic low-dose oral prednisone) or immunomodulatory treatment.
* Subject is unable to take colchicine for gout flare prophylaxis.
* Subject is receiving strong or moderate CYP3A inhibitors, p-glycoprotein inhibitors, or digoxin.
* Subject received any strong enzyme- inducing drug or product (eg, rifampin, rifabutin, phenytoin, phenobarbital, St. John's Wort) within 2 months prior to Day 1 or refuses to refrain from taking these medications until the end of the study.
* Subject received an investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to the Screening Period.
* Subject has any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
18 Years
70 Years
ALL
No
Sponsors
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Ardea Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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J. Hall, MD
Role: STUDY_DIRECTOR
Ardea Biosciences, Inc.
Locations
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Birmingham, Alabama, United States
Gulf Shores, Alabama, United States
Mobile, Alabama, United States
Glendale, Arizona, United States
Peoria, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Gold River, California, United States
Irvine, California, United States
San Leandro, California, United States
San Ramon, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Jacksonville, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Winter Haven, Florida, United States
Dunwoody, Georgia, United States
Honolulu, Hawaii, United States
Meridian, Idaho, United States
Gurnee, Illinois, United States
Elizabethtown, Kentucky, United States
Lexington, Kentucky, United States
Metairie, Louisiana, United States
Jackson, Mississippi, United States
Reno, Nevada, United States
New York, New York, United States
Charlotte, North Carolina, United States
Hickory, North Carolina, United States
Shelby, North Carolina, United States
Shelby, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Perrysburg, Ohio, United States
Willoughby Hills, Ohio, United States
Altoona, Pennsylvania, United States
Greenville, South Carolina, United States
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Rock Hill, South Carolina, United States
Spartanburg, South Carolina, United States
Spring Hill, Tennessee, United States
Houston, Texas, United States
Bountiful, Utah, United States
Midlothian, Virginia, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Countries
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Other Identifiers
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RDEA3170-201
Identifier Type: -
Identifier Source: org_study_id
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