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Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment

Renal Impairment Clinical Trial

Official title:
An Open-label, Parallel-group Study to Determine the Single and Multiple Dose Pharmacokinetics of Elinogrel and Its Metabolite in Patients With Mild, Moderate, and Severe Renal Impairment Compared to Healthy Subjects

Clinical Trial Summary

The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its metabolite in patients with mild, moderate, and severe renal impairment compared to healthy volunteers.

Clinical Trial Description

Multiple-dose, open-label parallel-group design in patients with mild, moderate or severe renal impairment and age (±7 years), sex and weight (±15% BMI) matched healthy subjects. - mild renal impairment: CrCl from 50 to ≤80 ml/min - moderate renal impairment: CrCl from 30 to <50 ml/min - severe renal impairment: CrCl of <30 ml/min ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00984113
Study type Interventional
Source Alexion
Contact
Status Terminated
Phase Phase 1
Start date September 2009
Completion date December 2009
View Details
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