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Bioequipotency Study of Idrabiotaparinux and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs

NCT00311090 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 757

Last updated 2016-03-21

No results posted yet for this study

Summary

The three purposes of this study are the following:

* To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;
* To compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment;
* To check the ability of avidin (SSR29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.

Conditions

  • Deep Venous Thrombosis

Interventions

DRUG

Idrabiotaparinux sodium

0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection

DRUG

Idraparinux sodium

0.5 mL pre-filled syringe for 2.5 mg Subcutaneous injection

DRUG

Avidin

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

DRUG

Placebo (for Avidin)

Avidin matching powder in 10 mg/mL solution Intravenous infusion for 30 minutes

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • France
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • New Zealand
  • Poland
  • Russia
  • South Africa
  • Spain
  • Turkey (Türkiye)

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 NCT00311090 on ClinicalTrials.gov