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NCT00311090 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Deep Venous Thrombosis, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
757
Enrollment target
20
Study locations

NCT00311090 is a Phase 3 study of Deep Venous Thrombosis that has completed, run by Sanofi. The registered enrollment target is 757 participants, above the 382-participant average among 9 other Deep Venous Thrombosis trials with a reported enrollment target (98% higher). The trial reports 20 study locations across 2 states.

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The verdict

NCT00311090, a Phase 3 study of Deep Venous Thrombosis, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
757 participants
Enrollment target
20
Study locations

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 Studied

Interventions

  • DRUG Idrabiotaparinux sodium
  • DRUG Idraparinux sodium
  • DRUG Avidin
  • DRUG Placebo (for Avidin)

Study Locations (20)

Other

  • Sanofi-Aventis - Buenos Aires
  • Sanofi-Aventis - Macquarie Park
  • Sanofi-Aventis - Vienna
  • Sanofi-Aventis - Diegem
  • Sanofi-Aventis - São Paulo
  • Sanofi-Aventis - Laval
  • Sanofi-Aventis - Prague
  • Sanofi-Aventis - Copenhagen
  • sanofi-aventis France - Paris
  • sanofi-aventis Israel - Netanya
  • Sanofi-aventis - Milan
  • sanofi-aventis Mexico - México
  • sanofi-aventis, Netherlands - Gouda
  • Sanofi-Aventis - New Zealand
  • Sanofi-Aventis - Warsaw
  • Sanofi-aventis - Moscow
  • Sanofi-Aventis - Midrand
  • Sanofi-Aventis - Barcelona
  • sanofi-aventis Turkey - Istanbul

New Jersey

  • Sanofi-Aventis - Bridgewater

Trial Details

FieldValue
Enrollment Target 757 participants
Start Date 2006-04
Est. Completion 2008-01
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00311090

The ClinicalTrials.gov registry entry for NCT00311090 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 757 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 382-participant average among 9 other Deep Venous Thrombosis trials with a reported enrollment target (98% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Deep Venous Thrombosis appearing as the primary indexed condition, and to 4 interventions - of which Idrabiotaparinux sodium is the first listed.

NCT00311090 reports 20 study locations spanning 2 distinct geographic areas - top geographies include Other, New Jersey.

Frequently Asked Questions

What is clinical trial NCT00311090 about?

NCT00311090 is a clinical study titled "Bioequipotency Study of Idrabiotaparinux and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs". 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;...

What is the current status of trial NCT00311090?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 757 participants. The study started on 2006-04. Estimated completion is 2008-01.

What conditions does trial NCT00311090 study?

This clinical trial studies the following conditions: Deep Venous Thrombosis.

What interventions are being tested in trial NCT00311090?

The interventions under investigation include: Idrabiotaparinux sodium (DRUG), Idraparinux sodium (DRUG), Avidin (DRUG), Placebo (for Avidin) (DRUG).

Who is sponsoring clinical trial NCT00311090?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00311090 being conducted?

This trial has 20 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.