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Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Severe Renal Impairment

2014-08-27 03:13:48 | BioPortfolio

Summary

Primary Objective:

- To study effect of severe renal impairment on the pharmacokinetics of otamixaban.

Secondary Objective:

- To assess the pharmacodynamic effects of otamixaban on subjects with severe renal impairment and in matched subjects with normal renal function.

Description

The duration of each part of the study for one subject was 28 days of screening, 1 day of treatment, with 5 days in the unit (Day -1 to Day 4) and a 8 to 11 days of follow-up after start of infusion.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Renal Impairment

Intervention

OTAMIXABAN (XRP0673)

Location

Sanofi-Aventis Investigational Site Number 840003
Miami Gardens
Florida
United States
33169

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:48-0400

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Medical and Biotech [MESH] Definitions

The prototypical uricosuric agent. It inhibits the renal excretion of organic anions and reduces tubular reabsorption of urate. Probenecid has also been used to treat patients with renal impairment, and, because it reduces the renal tubular excretion of other drugs, has been used as an adjunct to antibacterial therapy.

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