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NCT00694382 · ClinicalTrials.gov registry record · Phase 3

Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy

A Phase 3 study of Cancer and Venous Thromboembolism, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
3,212
Enrollment target
20
Study locations

NCT00694382 is a Phase 3 study of Cancer and Venous Thromboembolism that has completed, run by Sanofi. The registered enrollment target is 3,212 participants, roughly in line with the 3,486-participant average among 615 other Cancer trials with a reported enrollment target. The trial reports 20 study locations across 6 states.

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The verdict

NCT00694382, a Phase 3 study of Cancer and Venous Thromboembolism, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
3,212 participants
Enrollment target
20
Study locations

Study Summary

The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy. The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.

Interventions

  • DRUG Semuloparin sodium
  • DRUG Placebo (for semuloparin)

Study Locations (20)

California

  • Investigational Site Number 840050 - Fountain Valley
  • Investigational Site Number 840072 - Fullerton
  • Investigational Site Number 840037 - Indian Wells
  • Investigational Site Number 840069 - La Verne
  • Investigational Site Number 840009 - Long Beach
  • Investigational Site Number 840001 - Oceanside
  • Investigational Site Number 840011 - Rancho Mirage
  • Investigational Site Number 840029 - West Covina

Florida

  • Investigational Site Number 840074 - Clearwater
  • Investigational Site Number 840019 - Jacksonville
  • Investigational Site Number 840051 - Rockledge
  • Investigational Site Number 840073 - Sarasota

Connecticut

  • Investigational Site Number 840005 - Norwich
  • Investigational Site Number 840064 - Torrington
  • Investigational Site Number 840038 - Woodbridge

Arizona

  • Investigational Site Number 840007 - Casa Grande
  • Investigational Site Number 840060 - Tucson

District of Columbia

  • Investigational Site Number 840052 - Washington D.C.
  • Investigational Site Number 840025 - Washington D.C.

Alabama

  • Investigational Site Number 840006 - Birmingham

Trial Details

FieldValue
Enrollment Target 3,212 participants
Start Date 2008-06
Est. Completion 2010-11
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00694382

The ClinicalTrials.gov registry entry for NCT00694382 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,212 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 3,486-participant average among 615 other Cancer trials with a reported enrollment target. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which Semuloparin sodium is the first listed.

NCT00694382 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Connecticut.

Frequently Asked Questions

What is clinical trial NCT00694382 about?

NCT00694382 is a clinical study titled "Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy". The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy. The secondary objectives were to eva...

What is the current status of trial NCT00694382?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,212 participants. The study started on 2008-06. Estimated completion is 2010-11.

What conditions does trial NCT00694382 study?

This clinical trial studies the following conditions: Cancer, Venous Thromboembolism.

What interventions are being tested in trial NCT00694382?

The interventions under investigation include: Semuloparin sodium (DRUG), Placebo (for semuloparin) (DRUG).

Who is sponsoring clinical trial NCT00694382?

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

Where is trial NCT00694382 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. 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

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.