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Clinical Trial Details

Trial ID: L0595
Source ID: NCT01241539
Associated Drug: Dabigatran Etexilate
Title: Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01241539/results
Conditions: Cardiovascular Diseases|Kidney Failure, Chronic
Interventions: DRUG: Dabigatran etexilate|DRUG: Dabigatran etexilate|DRUG: Dabigatran etexilate
Outcome Measures: Primary: Dialysis Clearance of Dabigatran, Dialysis clearance of dabigatran from blood (CLD,b) and dialysis clearance of dabigatran from plasma (CLD) were calculated and indicate how quickly dabigatran is cleared out from blood or plasma., 4 hours|Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis, Extent of dabigatran that is removed from blood during one complete 4-hour cycle of dialysis was computed by the difference of plasma concentration at the start and at the end of dialysis relative to the start concentration and is therefore measured as a percentage., 4 hours|Plasma Concentration Extraction Ratio, Plasma concentration extraction ratio was measured directly at the dialysis machine and computed as the difference of the predialysis plasma concentration and the postdialysis plasma concentration relative to the predialysis concentration on the percentage scale (minimum: 0 percent of extraction (worst), maximum: 100 percent of extraction)., 4 hours | Secondary: Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h), Area under the concentration-time curve of total and free dabigatran in plasma over the time interval from 0 to 8 hours after the second and third administration of dabigatran., Days 2 and 3|Maximum Plasma Concentrations of Dabigatran (Cmax), Maximum measured concentration of total and free dabigatran in plasma after the second and third administration of dabigatran., Days 2 and 3|Time to Maximum Plasma Concentration (Tmax), Time to maximum plasma concentration of total and free dabigatran in plasma after the third administration of dabigatran., Day 3|Coagulation Parameters, Assessment of blood coagulation parameters 'activated partial thromboplastin time' (aPTT) and 'factor IIa inhibition' (anti-FIIa) measured with the diluted thrombin time assay. Time to the formation of a fibrin clot (coagulation) is measured in seconds., Day 3|Safety and Tolerability, Tolerability refers to the number of non-tolerable patients as assessed through the subjective examination of adverse events (AE). Safety refers to the number of patients with treatment emergent AEs. These numbers are presented on the overall Dabigatran treatment., 2 periods of 5 days each|Additional Safety Parameters, By study design abnormalities could be due to dialysis or Dabigatran., 2 periods of 5 days each
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 7
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose:
Start Date: 2010-11
Completion Date:
Results First Posted: 2012-07-27
Last Update Posted: 2014-04-07
Locations: 1160.121.1 Boehringer Ingelheim Investigational Site, Berlin, Germany
URL: https://clinicaltrials.gov/show/NCT01241539