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Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty

NCT00657150 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2055

Last updated 2014-07-02

Study results available
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Summary

The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

Enoxaparin

40 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
2008-03-31
Primary Completion
2009-09-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Hungary
  • India
  • Italy
  • Netherlands
  • New Zealand
  • 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 NCT00657150 on ClinicalTrials.gov