SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism

NCT00062803 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2009-04-29

No results posted yet for this study

Summary

Patients who have a pulmonary embolism (blood clot in the lung) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood-thinning) drug, SR34006, with the standard way of treating a pulmonary embolism. The standard treatment includes injections or infusions of an anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth.

Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.

Conditions

Interventions

DRUG

SR34006

DRUG

(LMW)heparin

DRUG

Warfarin VKA

DRUG

Acenocoumarol VKA

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2005-10-31
Completion
2005-10-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00062803 on ClinicalTrials.gov