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Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic Approach

NCT00345618 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3202

Last updated 2016-03-21

No results posted yet for this study

Summary

Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.

Conditions

Interventions

DRUG

Idrabiotaparinux sodium

0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection

DRUG

Warfarin

Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month) Oral administration

DRUG

Placebo (for idrabiotaparinux sodium)

0.5 mL pre-filled syringe Subcutaneous injection

DRUG

Avidin

100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes

DRUG

Placebo (for warfarin)

Warfarin matching capsules Oral administration

DRUG

Enoxaparin

Prefilled syringes as locally registered Subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czechia
  • Denmark
  • Egypt
  • Estonia
  • France
  • Greece
  • India
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT00345618 on ClinicalTrials.gov