NCT00847301

Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 472 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Arthroplasty, Replacement
• Thromboembolism

Timeline

• Start date: 2009-04-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2009-02-19
• Last updated: 2015-09-25
• Results posted: 2015-09-25

Locations

53 sites across 7 countries: Austria, France, Germany, Italy, Spain, Sweden, United Kingdom