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Type(s) of Cancer
Colorectal, Lung, Ovarian, Pancreas, Unspecified Adult Solid Tumor
Study Phase
Phase 3
Study Completion Date
November 2010
NCT00694382Uploaded 03-14-2015
Available for Download
PDS UID: Multiple_SanofiU_2008_119
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
Provider Information
Provider Data DescriptionPrimary: To compare the efficacy of semuloparin 20 mg subcutaneous (SC), once daily (QD) with placebo SC QD for the prevention of venous thromboembolism (VTE) in cancer patients at high VTE risk and undergoing chemotherapy. Secondary: To evaluate the safety of semuloparin in cancer patients undergoing chemotherapy, to document semuloparin exposures, to try identifying a metagene predictor of VTE, and to assess the survival status at one year in this population.
SponsorSanofi US Services Inc.
Data ProviderSanofi
Partial set or SubsetOriginal Data
Patients in dataset3212
# of Patients Control1604
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/e2jd-y594
CDISC StandardSDTM
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe 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.
ConditionsVenous Thromboembolism
Cancer
Intervention TypeDrug: Semuloparin sodium
Drug: Placebo (for semuloparin)
Drug(s)Drug: Semuloparin sodium
Drug: Placebo (for semuloparin)
Total Enrolled3212
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionSemuloparin - Experimental
Placebo - Placebo Comparator
Secondary ID2007-007943-29
PubMed (PMID)22335737
33337539
Collaborator(s)N/A
Region(s)United States
Argentina
Australia
Austria
Belarus
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hong Kong
Hungary
India
Indonesia
Ireland
Israel
Italy
Korea, Republic of
Latvia
Lithuania
Malaysia
Mexico
Netherlands
Norway
Peru
Poland
Portugal
Romania
Russian Federation
Serbia
Slovakia
Slovenia
South Africa
Spain
Sweden
Switzerland
Taiwan
Ukraine
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLsanofi_ave5026_EFC6521_Clinical_Trial_Protocol.pdf
CRFsanofi_ave5026_efc6521-14-1-2-sample-crf.pdf
DATA DICTIONARYsanofi_ave5026_efc6521.xlsx
DATA (COMPARATOR ARM)sanofi_ave5026_README (EFC6521 de-identification notes).docx
DATA (COMPARATOR ARM)AVE5026_EFC6521_data.zip
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