At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 7 enrolled
Drug / intervention
Dabigatran etexilate +2 moredrug
Likely dose
Dabigatran etexilate 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Dabigatran etexilate for Cardiovascular Diseases and Kidney Failure, Chronic. Completed, enrolled 7 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Diseases, Kidney Failure, Chronic
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2010
First PostedNov 2010
Primary CompletionMay 2011
TodayJul 2026
First PostedNov 16, 2010
Enrollment StartNov 1, 2010
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.6 years ago
Interventions
Dabigatran etexilatedrug
150 mg capsule
Dabigatran etexilatedrug
75 mg capsule
Dabigatran etexilatedrug
110 mg capsule