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RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery

NCT00168805 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2101

Last updated 2014-05-19

Study results available
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Summary

A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s \[150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery\] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

Conditions

  • Arthroplasty, Replacement, Knee
  • Thromboembolism

Interventions

DRUG

enoxaparin

40 mg once daily

DRUG

dabigatran etexilate

150 mg once daily

DRUG

dabigatran etexilate

220 mg once daily

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
2004-11-30
Primary Completion
2006-05-31

Countries

  • Australia
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • South Africa
  • Spain
  • 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 NCT00168805 on ClinicalTrials.gov