NCT01241539

Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis

Open Label, Non Randomized, Multiple Dose Phase I Study to Investigate the Elimination, Pharmacokinetics, Pharmacodynamics and Safety of Dabigatran Etexilate (Pradaxa) Under Steady State Conditions Before, During and After Haemodialysis in Patients With End Stage Renal Disease (ESRD) Undergoing Regular Haemodialysis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.

Conditions

• Cardiovascular Diseases
• Kidney Failure, Chronic

Interventions

Type	Name	Description
DRUG	Dabigatran etexilate	150 mg capsule
DRUG	Dabigatran etexilate	75 mg capsule
DRUG	Dabigatran etexilate	110 mg capsule

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-05-01
• First posted: 2010-11-16
• Last updated: 2014-04-07
• Results posted: 2012-07-27

Locations

1 site across 1 country: Germany