At a glance
ClinicalIndex Comparison RecordN/ACompleted· 472 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in 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.
Observational Cohort Study to Evaluate Safety and Efficacy of Pradaxa (Dabigatran Etexilate) in Patients With Moderate Renal Impairment (Creatinine Clearance 30-50 ml/Min) Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery
In Brief
An observational study for Arthroplasty, Replacement and Thromboembolism. Completed, enrolled 472 participants across 53 sites in 7 countries.
Detailed Summary
An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsArthroplasty, Replacement, Thromboembolism
CountriesAustria, France, Germany, Italy, Spain, Sweden, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2009
Enrollment StartApr 2009
Primary CompletionJul 2014
TodayJul 2026
First PostedFeb 19, 2009
Enrollment StartApr 1, 2009
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 17.4 years ago