A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy
Randomization had to take place just prior to the first study drug injection (randomization
ratio 1:1).
The study period per participant was variable depending on the duration of chemotherapy. It
included:
- a screening period up to 3 weeks,
- a double-blind treatment period,
- a follow-up period of 1 month.
Study end date was at the latest 7 months following the randomization of the last
participant (6 months treatment and 1 month follow-up).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death
VTE included any symptomatic Deep Vein Thrombosis [DVT] of lower or upper limbs and any non-fatal Pulmonary Embolism [PE] as confirmed by a Central Independent Adjudication Committee [CIAC] after review of compression ultrasound or venography for DVT, ventilation/perfusion lung scan, pulmonary angiogram or spiral computer tomography lung scan for PE. VTE-related death included fatal PE and unexplained deaths without confirmatory autopsy. Any sudden death could be classified as fatal PE by the CIAC unless diagnostic test results strongly indicated an alternative diagnosis".
From randomization up to 3 days after last study drug injection
No
Alexander Turpie, MD
Study Chair
HHS-General Hospital, Hamilton, Canada
United States: Food and Drug Administration
EFC6521
NCT00694382
June 2008
November 2010
Name | Location |
---|---|
Investigational Site Number 840001 | Vallejo, California 94589 |
Investigational Site Number 840026 | Charlotte, North Carolina 28262 |
Investigational Site Number 840034 | Waco, Texas 76708 |
Investigational Site Number 840009 | Modesto, California 95355 |
Investigational Site Number 840019 | Jacksonville, Florida 32256 |
Investigational Site Number 840011 | Palo Alto, California 94301 |
Investigational Site Number 840004 | Houston, Texas 77030 |
Investigational Site Number 840006 | Birmingham, Alabama 35211 |
Investigational Site Number 840007 | Casa Grande, Arizona 85222 |
Investigational Site Number 840060 | Tucson, Arizona 85704 |
Investigational Site Number 840050 | Fountain Valley, California 92708 |
Investigational Site Number 840072 | Fullerton, California 92835 |
Investigational Site Number 840037 | Indian Wells, California 92210 |
Investigational Site Number 840069 | La Verne, California 91750 |
Investigational Site Number 840029 | West Covina, California 91790 |
Investigational Site Number 840005 | Norwich, Connecticut 06360 |
Investigational Site Number 840064 | Torrington, Connecticut 06790 |
Investigational Site Number 840038 | Woodbridge, Connecticut 06525 |
Investigational Site Number 840025 | Washington, District of Columbia 20017 |
Investigational Site Number 840052 | Washington, District of Columbia 20010 |
Investigational Site Number 840074 | Clearwater, Florida 33756 |
Investigational Site Number 840051 | Rockledge, Florida 32955 |
Investigational Site Number 840073 | Sarasota, Florida 34239 |
Investigational Site Number 840070 | Roswell, Georgia 30076 |
Investigational Site Number 840016 | Park Ridge, Illinois 60068 |
Investigational Site Number 840028 | Quincy, Illinois 62301 |
Investigational Site Number 840008 | Skokie, Illinois 60077 |
Investigational Site Number 840033 | Goshen, Indiana 46526 |
Investigational Site Number 840010 | Indianapolis, Indiana 46237 |
Investigational Site Number 840014 | Louisville, Kentucky 40202 |
Investigational Site Number 840048 | Mount Sterling, Kentucky 40353 |
Investigational Site Number 840047 | Metairie, Louisiana 70056 |
Investigational Site Number 840032 | Ruston, Louisiana 71270 |
Investigational Site Number 840042 | Bethesda, Maryland 20817 |
Investigational Site Number 840066 | Easton, Maryland 21601 |
Investigational Site Number 840059 | Tupelo, Mississippi 38801 |
Investigational Site Number 840024 | Rochester, New York 14642 |
Investigational Site Number 840031 | Syracuse, New York 13210 |
Investigational Site Number 840020 | Durham, North Carolina 27710 |
Investigational Site Number 840021 | Durham, North Carolina 27710 |
Investigational Site Number 840046 | Bismarck, North Dakota 58501 |
Investigational Site Number 840003 | Middletown, Ohio 45042 |
Investigational Site Number 840022 | Sylvania, Ohio 43560 |
Investigational Site Number 840075 | East Providence, Rhode Island 02915 |
Investigational Site Number 840067 | Beaumont, Texas 77701 |
Investigational Site Number 840035 | Sugar Land, Texas 77055 |
Investigational Site Number 840063 | Kennewick, Washington 99336 |
Investigational Site Number 840018 | Tacoma, Washington 98431 |