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



Status:Completed
Conditions:Gout
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 60
Updated:2/7/2015
Start Date:July 2014
End Date:January 2015
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

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A Randomized, Double Blind, Third Party Open, Placebo Controlled Multi-center Study Of Efficacy, Safety And Tolerability Of Pf-06743649 In Gout Subjects

The purpose of the study is to assess the effect of PF-06743649 in lowering serum uric acid
in subjects suffering from gout following 14 days of dosing, as well as assessing safety and
tolerability.


Inclusion Criteria:

- 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:

- 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 < 60 mL/min/1.73m2 calculated by the
Cockcroft-Gault equation.

- Subjects with current tophaceous gout.

- Gout flare that has not resolved for at least 2 weeks prior to randomization.
We found this trial at
4
sites
6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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Miami, Florida 33143
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Overland Park, Kansas 23112
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Overland Park, Kansas 23112
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