Expired Study
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Orlando, Florida 32809


Purpose:

The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg Apixaban in subjects with normal renal function and subjects with end stage renal disease (ESRD) maintained with hemodialysis.


Study summary:

Primary Purpose : To provide a clear understanding of the pharmacokinetics of Apixaban in subjects with ESRD and to determine the effect of hemodialysis on Apixaban pharmacokinetics .


Criteria:

Inclusion Criteria: - The signed informed consent form. - Subjects with normal renal function classified based on calculated creatinine clearance determined by the cockcroft-gault calculation. - Eligible subjects with ESRD that is maintained with chronic and stable hemodialysis. Exclusion Criteria: - Any history of abnormal bleeding or coagulation disorders including those in a first degree relative under 50 years of age. - History of significant head injury within the last two years. - Any gastrointestinal surgery that could impact the absorption of study drug. - Not expected to continue the hemodialysis treatment for the duration of the study. - INR, PT, or aPTT above the upper limit of normal, unless agreed upon between the investigator and BMS medical monitor. - History of allergy to Apixaban or Factor Xa inhibitors.


NCT ID:

NCT01340586


Primary Contact:

Study Director
Bristol-Myers Squibb
Bristol-Myers Squibb


Backup Contact:

N/A


Location Contact:

Orlando, Florida 32809
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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