Value through Innovation27 July 2016

Clinical Study Results

  • ACTILYSE ® - Stroke
    Clinical Study Number 135.312
    Study Indication Stroke
    Product ACTILYSE ®
    Generic Name Alteplase
    Lab Code
    Clinical Phase IIIb
    Study Title

    ECASS III – European Cooperative Acute Stroke Study III: A placebo controlled trial of alteplase in acute ischemic hemispheric stroke where thrombolysis is initiated between 3 and 4 hours 30 minutes after stroke onset.

    Study Document Trial synopsis 135.312_CO english
  • ACTILYSE ® - Stroke
    Clinical Study Number 135.313
    Study Indication Stroke
    Product ACTILYSE ®
    Generic Name Alteplase
    Lab Code
    Clinical Phase IV
    Study Title

    Safe implements of Thrombolysis in Stroke -MOnitoring STudy (SITS-MOST)

    Study Document Trial synopsis 135.313_CO english
  • ACTILYSE ® - Stroke
    Clinical Study Number 135.315
    Study Indication Stroke
    Product ACTILYSE ®
    Generic Name Alteplase
    Lab Code
    Clinical Phase IV
    Study Title

    Actilyse PMS study final report

    Study Document Trial synopsis 135.315_CO english
  • ACTILYSE ® - Myocardial Infarction
    Clinical Study Number 135.301
    Study Indication Myocardial Infarction
    Product ACTILYSE ®
    Generic Name Alteplase
    Lab Code
    Clinical Phase IV
    Study Title

    A multicentre, feasibility study of pre-hospital treatment of acute myocardial infarction based on diagnosis by interpretation of remotely acquired ECG and thrombolysis with accelerated alteplase (Actilyse®). Pre-Hospital Alteplase Remote Advice Of Hospital (PHARAOH)

    Study Document Trial synopsis 135.301 english
  • ACTILYSE ® - Stroke
    Clinical Study Number 135.317
    Study Indication Stroke
    Product ACTILYSE ®
    Generic Name Alteplase
    Lab Code
    Clinical Phase IV
    Study Title

    SITS-NEW Safe Implementation of Thrombolysis in Stroke in the Non EUWorld: An International observational study of the Safety and Efficacy of Thrombolysis in stroke

    Study Document Trial synopsis 135.317 english
  • ACTILYSE ® - Catheter Obstruction
    Clinical Study Number 135.323
    Study Indication Catheter Obstruction
    Product ACTILYSE ®
    Generic Name Alteplase
    Lab Code
    Clinical Phase III
    Study Title

    A multicenter, open-label, randomised, clinical trial to compare the efficacy and safety of Actilyse® 2 mg/ 2 ml versus saline solution in restoring function of an occluded central venous access device

    Study Document Trial synopsis 135.323_DR english
  • ACTILYSE ® - Stroke
    Clinical Study Number 135.331
    Study Indication Stroke
    Product ACTILYSE ®
    Generic Name Alteplase
    Lab Code
    Clinical Phase IIIb
    Study Title

    An open label, multicentre, single-arm trial to assess safety and efficacy of alteplase (rt-PA) in Chinese patients with acute ischemic hemispheric stroke where thrombolysis is initiated between 3 and 4.5 hours after stroke onset

    Study Document Trial synopsis 135.331 english

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.