MedTrace Logo

Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement

NCT00152971 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2615

Last updated 2014-05-05

Study results available
· View outcomes & findings →

Summary

To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery

Conditions

  • Arthroplasty, Replacement, Knee
  • Thromboembolism

Interventions

DRUG

Dabigatran Dose 1 - day 2 to completion

low dose regimen taken once daily

DRUG

Dabigatran Dose 1 - day 1

low dose regimen taken once daily

DRUG

Dabigatran Dose 2 - day 2 to completion

high dose regimen taken once daily

DRUG

Dabigatran Dose 2 - day 1

high dose regimen taken once daily

DRUG

Enoxaparin

30 mg subcutaneously twice 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
2006-06-30

Countries

  • United States
  • Canada
  • Mexico
  • United Kingdom

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 NCT00152971 on ClinicalTrials.gov