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COMPLETED Phase 3

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

NCT00311090 · View on ClinicalTrials.gov ↗

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

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00311090

The ClinicalTrials.gov registry entry for NCT00311090 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 757 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00311090 reports 20 study locations spanning 2 distinct geographic areas — top geographies include Other, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00311090?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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