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A Multinational, Multicenter, Randomized, Double-Blind study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Hip Fracture Surgery (SAVE HIP 2) [Estudio Multinacional, Multicéntrico, Randomizado, Doble Ciego, para comparar la eficacia y seguridad de AVE5026 frente a enoxaparina en la Prevención de Tromboembolismo Venoso en Pacientes sometidos a Cirugía de Fractura de Cadera]

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Trial Profile

A Multinational, Multicenter, Randomized, Double-Blind study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Hip Fracture Surgery (SAVE HIP 2) [Estudio Multinacional, Multicéntrico, Randomizado, Doble Ciego, para comparar la eficacia y seguridad de AVE5026 frente a enoxaparina en la Prevención de Tromboembolismo Venoso en Pacientes sometidos a Cirugía de Fractura de Cadera]

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2016

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At a glance

  • Drugs Semuloparin (Primary) ; Enoxaparin sodium
  • Indications Deep vein thrombosis; Pulmonary embolism; Thromboembolism; Venous thromboembolism
  • Focus Registrational; Therapeutic Use
  • Acronyms SAVE-HIP2
  • Sponsors Sanofi

Most Recent Events

  • 16 Mar 2012 Primary endpoint 'Venous-thromboembolism-event-rate' has not been met according to results published in the Journal of Thrombosis and Haemostasis.
  • 03 Feb 2010 Sanofi Synthelabo added as trial sponsor and lead centre as reported by Clinical Trials Registry - India record.
  • 03 Feb 2010 New source identified and integrated (Clinical Trials Registry - India record).

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