Clinical trial
An Open-label Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban Given as a Single 80 μg/kg Bolus Plus 100 µg/kg/h Continuous Infusion for 24 Hours in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function
NCT01120314 is registered in ClinicalTrials.gov with Sanofi as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- An Open-label Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban Given as a Single 80 μg/kg Bolus Plus 100 µg/kg/h Continuous Infusion for 24 Hours in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function
- Lead sponsor
- Sanofi
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- April 30, 2010
- Completion date
- July 31, 2011
- Enrollment
- 48 (actual)
- Sites
- 4
Conditions
As the registry lists them; a condition with its own page is linked.
renal impairment