Pharmacokinetics and –dynamics of Dabigatran Etexilate and Rivaroxaban in patients requiring PArenteral Nutrition (the PDER PAN study)
Recruiting
- Conditions
- parenteral nutrition, thrombosis, pharmacokinetics, pharmacodynamics, anticoagulant
- Registration Number
- NL-OMON26342
- Lead Sponsor
- Academic Medical Center, Amsterdam, The Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
Inclusion criteria are:
-clinically stable adult male and female patients (age between 18 and 75 years),
Exclusion Criteria
Exclusion criteria are:
-moderate/severe renal impairment (CKD EPI Creatinine Clearance < 50 mL/min according to http://www.nephron.com/MDRD_GFR.cgi), or moderate/severe hepatic impairment (class B (7-9 points) or class C (10-15 points) at the Child-Pugh score),
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the assessment of PK and PD parameters of the two drugs and the comparison to published values.
- Secondary Outcome Measures
Name Time Method The secondary outcome is the comparison between rivaroxaban PK parameters and dabigatran PK parameters (AUC, Cmax and Tmax).