Value through Innovation27 July 2016

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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 ® - 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
  • AGGRENOX ® - Stroke
    Clinical Study Number 9.182
    Study Indication Stroke
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase IV
    Study Title

    Prospective, randomised, national, multi-centre, open-label, blinded endpoint study to compare Aggrenox® b.i.d. (200 mg dipyridamole MR + 25 mg acetylsalicylic acid) when started within 24 hours of stroke onset on an acute stroke unit, and Aggrenox® b.i.d. when started after a 7-day therapy with ASA 100 mg once daily outside of an acute stroke unit, in symptomatic ischaemic stroke patients over a three months treatment period (EARLY) - An exploratory study

    Study Document
    Trial synopsis 9.182_DS_DR english
  • AGGRENOX ® - Stroke
    Clinical Study Number 9.178
    Study Indication Stroke
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase III
    Study Title

    Japanese Aggrenox Stroke Prevention vs. Aspirin Programme (JASAP): Phase III study to evaluate the preventive effect of recurrent cerebral infarction and safety of Aggrenox (a combination drug containing sustained-release dipyridamole 200 mg and acetylsalicylic acid 25 mg) twice daily compared with acetylsalicylic acid 81 mg once daily

    Study Document
    Trial Synopsis 9.178_CO english
  • AGGRENOX ® - Stroke
    Clinical Study Number 9.155
    Study Indication Stroke
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase III
    Study Title

    Tolerability of a Four Weeks Treatment with Aggrenox® Modified Release Capsules b.i.d, Compared to Reduced Dose During the First Two Weeks of Treatment in a Double-Blind, Randomized Controlled Parallel Group Comparison Trial among Taiwanese Patients with Previous TIAs or Ischemic Stroke

    Study Document
    Trial synopsis 9.155 english
  • AGGRENOX ® - Stroke
    Clinical Study Number 9.159
    Study Indication Stroke
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase III/IV
    Study Title

    PRoFESS – Prevention Regimen For Effectively avoiding Second Strokes: A double-blind, active and placebo controlled study of Aggrenox® vs. clopidogrel, with and without Micardis®

    Study Document
    Trial synopsis 9.159_DS_CO english
  • Crobenetine - Stroke
    Clinical Study Number 599.3
    Study Indication Stroke
    Product Crobenetine
    Generic Name Crobenetine
    Lab Code
    Clinical Phase II
    Study Title

    A randomised, double-blind, placebo-controlled, clinical trial to evaluate the safety and tolerability in 108 patients (18 per dose group) with acute ischemic stroke after intravenous administration from 6 to 72 hours of BIII 890, as loading dose followed by maintenance dose, in escalating dose panels from 87.5 mg up to 1495 mg (total dose)

    Study Document
    Trial synopsis 599.3_CO english
  • LISAGIL ® - Stroke
    Clinical Study Number 1093.15
    Study Indication Stroke
    Product LISAGIL ®
    Generic Name Metamizole
    Lab Code
    Clinical Phase IV
    Study Title

    A randomized, multicentre, double-blind clinical trial of Metamizole 2g /8 h, i.v. ampoules, versus Placebo every 8 h, i.v. ampoules, administered during 3 days consecutively as antithermic therapy in the acute phase of ischemic stroke. A 30-day study. (ATIS Study)

    Study Document
    Trial synopsis 1093.15 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