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Efficacy, Safety And Tolerability Of PF-06743649 In Gout Subjects.

Last updated on February 22, 2019

FOR MORE INFORMATION
Study Location
MRA Clinical Research, LLC
Miami, Florida, 33143 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gout
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Subject meets the diagnosis of gout as per the American Rheumatism Association
Criteria for the Classification of acute Arthritis of Primary Gout.

- Subjects taking urate lowering therapy at the time of screening must be willing to
discontinue their prior urate lowering therapy from the time of Screening Visit 1
until completion of the study period Day 16.

- Subjects taking urate lowering therapy at the time of screening must have a serum
urate level of >= 8.0 mg/dL at time of the second screening visit.

- Subjects NOT taking urate lowering therapy at the time of screening must have a serum
urate level of >= 8.0 mg/dL at both screening visits 1 and 2.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Positive medical history or current evidence of medical or psychiatric
condition/disease, or ECG or laboratory abnormality that may increase the risk
associated with study participation or investigational product administration or may
interfere with the interpretation of study results and, in the judgment of the
Investigator, would make the subject inappropriate for entry into this study.

- Chronic kidney disease classified as moderate or severe (Clinical Practice Guideline,
National Kidney Foundation)12; with GFR Cockcroft-Gault equation.

- Subjects with current tophaceous gout.

- Gout flare that has not resolved for at least 2 weeks prior to randomization.

NCT02187029
Pfizer
Terminated
Efficacy, Safety And Tolerability Of PF-06743649 In Gout Subjects.

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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