Trial Condition(s):

Thromboembolic disorders

BAY59-7939, Dialysis Heamofiltration Study

Bayer Identifier:

12890

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-003913-27

Study Completed

Trial Purpose

The main objective of the study was to investigate the effect of hemodialysis on the pharmacokinetics (PK) maximum observed drug concentration in measured matrix after single dose administration (Cmax), Cmax divided by dose per body weight (Cmax,norm), area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) and AUC divided by dose per body weight (AUCnorm)) of rivaroxaban (Xarelto / BAY59-7939) in subjects with end-stage renal disease (ESRD) on hemodialysis and age-, body weight-, and gender-matched healthy volunteers.

Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
32
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Kiel, Germany, 24105

Status
Completed
 

Trial Design