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Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium)

NCT00951574 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1166

Last updated 2012-02-01

No results posted yet for this study

Summary

In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in double-blind conditions to a treatment with subcutaneous low molecular weight heparin (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy or up to a maximum of 4 months (+/- 10 days).

Conditions

Interventions

DRUG

Nadroparin calcium

Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).

DRUG

saline solution (placebo)

Pre-filled syringes of 0.4 ml , 1 subcutaneous injection/day (every 24 hours).

Sponsors & Collaborators

  • Italfarmaco

    lead INDUSTRY

Principal Investigators

  • Giancarlo Agnelli, MD · Internal and Vascular Medicine University of Perigia (Italy)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2007-05-31
Completion
2008-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT00951574 on ClinicalTrials.gov