Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild, Moderate and Severe Renal Impairment
| Status: | Archived |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | April 2010 |
| End Date: | August 2011 |
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
Primary Objective:
- To study effect of mild, moderate and severe renal impairment on the pharmacokinetics
of Otamixaban.
Secondary Objective:
- To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and
severe renal impairment and in matched subjects with normal renal function.
The study period for one subject is broken down as follows:
- 2 to 28 days of screening,
- 1 day of treatment,
- 8 to 11 days of follow-up after start of infusion.
There are 5 days in the unit starting the day before the start of infusion.
We found this trial at
4
sites
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