drugset / Trial / NCT01225822

BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery

NCT01225822

Phase 2 Completed 1973 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindPrevention

Summary

The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients undergoing primary elective total hip and knee replacement.

Timeline

Start
2002-11
Primary completion
2003-08
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran etexilate Unknown 50 mg
Subject Dabigatran etexilate Unknown 150 mg
Subject Dabigatran etexilate Unknown 225 mg
Subject Dabigatran etexilate Unknown 300 mg
Comparator Enoxaparin sodium Other / unclassified 40 mg Subcutaneous