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COMPLETED Phase 3

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

NCT00694382 · View on ClinicalTrials.gov ↗

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

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00694382

The ClinicalTrials.gov registry entry for NCT00694382 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 3,212 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 2 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions — of which Semuloparin 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: NCT00694382 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Connecticut. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00694382?

The interventions under investigation include: Semuloparin sodium (DRUG), Placebo (for semuloparin) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00694382?

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 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.

Related

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