CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,973 enrolled
Drug / intervention
Enoxaparin +4 moredrug
Likely dose
Enoxaparin 40 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.

Search/NCT01225822
NCT01225822Phase 2Completed
CompareCT.gov

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

Boehringer Ingelheim·interventional·Posted Oct 21, 2010·Updated May 19, 2014

In Brief

A Phase 2 clinical trial evaluating Enoxaparin and BIBR 1048 for Venous Thromboembolism. Completed, enrolled 1,973 participants across 59 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism
CountriesAustria, Belgium, Czechia, Denmark, Finland, France, Hungary, Italy, Netherlands, Norway, South Africa, Sweden
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 21, 2010
Enrollment StartNov 1, 2002
Primary CompletionAug 1, 2003
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.7 years ago

Interventions

Enoxaparindrug

Enoxaparin 40 mg s.c once a day for 5-10 days of treatment period

BIBR 1048drug

50 mg b.i.d BIBR 1048 capsule twice a day for 5-10 days of treatment period

BIBR 1048drug

150 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period

BIBR 1048drug

225 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period

BIBR 1048drug

300 mg q.d BIBR 1048 capsule for 5-10 treatment period