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A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.

NCT00246025 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2014-06-09

Study results available
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Summary

The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-response.

Conditions

  • Arthroplasty, Replacement, Knee
  • Venous Thrombosis

Interventions

DRUG

Dabigatran etexilate

Dabigatran etexilate 110 mg capsule, once a day, oral administration

DRUG

Dabigatran etexilate

Dabigatran etexilate 150 mg capsule, once a day, oral administration

DRUG

Dabigatran Etexilate

Dabigatran etexilate 220 mg capsule, once a day, oral administration

DRUG

placebo

matching placebo capsule, once a day, oral administration

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2007-06-30

Countries

  • Japan

Study Locations

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Entities

Drugs
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 NCT00246025 on ClinicalTrials.gov