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 ® - 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

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

European Trial Register of EU studies.