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Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

NCT00168818 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3494

Last updated 2014-05-19

Study results available
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Summary

The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

Conditions

  • Thromboembolism
  • Arthroplasty, Replacement, Hip

Interventions

DRUG

dabigatran etexilate

daily dose 150 mg once daily, half a dose on the day of surgery

DRUG

dabigatran etexilate

daily dose 150 mg once daily, half a dose on the day of surgery

DRUG

enoxaparin

40 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
2006-07-31

Countries

  • Australia
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Norway
  • 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 NCT00168818 on ClinicalTrials.gov