Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy (SAVE-ONCO)
Tracking Information
Start Date ICMJE | June 2008 |
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Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: August 11, 2008) | Time-to-first occurrence of symptomatic Deep Venous Thrombosis of lower or upper limbs, non fatal Pulmonary embolism, and VTE-related deaths [ Time Frame: From randomization up to 3 calendar days after last study drug injection ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: June 6, 2008) | Time-to-first occurrence of symptomatic Deep Venous Thrombosis of lower or upper limbs, non fatal Pulmonary embolism, and VTE-related deaths [ Time Frame: From randomization up to 3 calendar days after last study drug injection ] |
Change History | Complete list of historical versions of study NCT00694382 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: July 31, 2008) |
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Original Secondary Outcome Measures ICMJE (submitted: June 6, 2008) |
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Descriptive Information
Brief Title ICMJE | Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy |
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Official Title ICMJE | 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 |
Brief Summary | The primary objective is to compare the efficacy of once daily (q.d.) subcutaneous (s.c.) injections of AVE5026 with placebo in the prevention of venous thromboembolism (VTE) in cancer patients at high risk for VTE and who are undergoing chemotherapy. The secondary objectives are to evaluate the safety of AVE5026, to document AVE5026 exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population. |
Detailed Description | The study treatment duration is variable depending on the duration of chemotherapy. |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 3200 | ||||
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Estimated Completion Date | September 2010 | ||||
Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial | ||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, 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, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00694382 | ||||||||
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Responsible Party | ICD Study Director, Sanofi-aventis | ||||||||
Study ID Numbers ICMJE | EFC6521, EudraCT 2007-007943-29 | ||||||||
Study Sponsor ICMJE | Sanofi-Aventis | ||||||||
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Investigators ICMJE |
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Information Provided By | Sanofi-Aventis |
Source: http://clinicaltrials.gov/