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

NCT01225822 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1973

Last updated 2014-05-19

Study results available
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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.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

Enoxaparin

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

DRUG

BIBR 1048

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

DRUG

BIBR 1048

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

DRUG

BIBR 1048

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

DRUG

BIBR 1048

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2003-08-31

Countries

  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Hungary
  • Italy
  • Netherlands
  • Norway
  • South Africa
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01225822 on ClinicalTrials.gov