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 and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function.
NCT01126086 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 and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function.
- Lead sponsor
- Sanofi
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- May 31, 2010
- Completion date
- April 30, 2011
- Enrollment
- 25 (actual)
- Sites
- 3
Conditions
As the registry lists them; a condition with its own page is linked.
hepatic impairment