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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death

Outcome Description:

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".

Outcome Time Frame:

From randomization up to 3 days after last study drug injection

Safety Issue:

No

Principal Investigator

Alexander Turpie, MD

Investigator Role:

Study Chair

Investigator Affiliation:

HHS-General Hospital, Hamilton, Canada

Authority:

United States: Food and Drug Administration

Study ID:

EFC6521

NCT ID:

NCT00694382

Start Date:

June 2008

Completion Date:

November 2010

Related Keywords:

• Venous Thromboembolism
• Cancer
• chemotherapy
• Thromboembolism
• Venous Thromboembolism
• Venous Thrombosis