CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 63 enrolled
Drug / intervention
Pradaxa, dabigatran etexilatedrug
Likely dose
Pradaxa, dabigatran etexilate 75mgfrom 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.

Search/NCT01896297
NCT01896297Phase 4Completed
CompareCT.gov

A Prospective, Open Label Study to Evaluate the Pharmacokinetics of Dabigatran in Non-valvular Atrial Fibrillation (NVAF) Patients With Severely Impaired Renal Function on Dabigatran Etexilate 75 mg BID Therapy

Boehringer Ingelheim·interventional·Posted Jul 11, 2013·Updated Nov 30, 2016

In Brief

A Phase 4 clinical trial evaluating Pradaxa, dabigatran etexilate for Atrial Fibrillation. Completed, enrolled 63 participants across 26 sites.

Detailed Summary

The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by Cockcroft-Gault formula. The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and simulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 11, 2013
Enrollment StartJul 1, 2013
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.0 years ago

Interventions

Pradaxa, dabigatran etexilatedrug

75mg BID by oral