Value through Innovation27 July 2016

Clinical Study Results

  • 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 ® - Coronary Artery Disease
    Clinical Study Number 9.169
    Study Indication Coronary Artery Disease
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised, crossover study comparing the biochemical and platelet effects of modified-release dipyridamole/aspirin (200mg/25 mg bd; Asasantin Retard®) with aspirin (75 mg qd) in coronary artery disease patients with aspirin resistance manifesting as persistent thromboxane formation.

    Study Document Trial synopsis 9.169_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
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.197
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Drug-Drug Interaction Study of the Effect of Omeprazole 80 mg q.d. at Steady State on the Pharmacokinetics and Pharmacodynamics of Aggrenox ® Every 12 Hours at Steady State in Healthy Male and Female Volunteers (an Open-Label, Randomized, Crossover Study)

    Study Document Trial synopsis 9.197_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.127
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics and safety of Asasantin extended release (RAD-SP) 200/25 mg capsules b.i.d. in randomised, double-blind, placebo­ controlled study in Japanese healthy male volunteers

    Study Document Trial synopsis 9.127_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.130
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, two-period, cross over trial to compare the effects of acetylsalicylic acid (75 mg/day) with the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole (200 mg) (bd) on serum thromboxane B2 formation and platelet aggregation in healthy volunteers

    Study Document Trial synopsis 9.130_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.131
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Tolerability of a two week treatment with Asasantin extended release 200/25 mg capsules b.i.d, compared to reduced dose during the first week of treatment in a double-blind, randomised, placebo controlled parallel group comparison trial in healthy female and male subjects

    Study Document Trial synopsis 9.131_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.136
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Impact of food on pharmacokinetics and pharmacodynamics of Asasantin extended release (ER) 200/25 mg capsules b.i.d. in a randomized, open, 2-way cross-over study in healthy subjects.

    Study Document Trial synopsis 9.136_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.138
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Comparison of pharmacokinetics of dipyridamole in Asasantin extended release (ER) 200/25 mg capsules bid and in a combination of Persantin immediate release tablets (100 mg qid) and ASA tablets (25 mg bid) in an open, randomized, 2-way crossover study in healthy subjects.

    Study Document Trial synopsis 9.138_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.142
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Mechanism of dipyridamole action in platelets: in-vivo study with healthy volunteers

    Study Document Trial synopsis 9.142 english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.144
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, 3-way cross-over study to compare the pharmacokinetics of dipyridamole in three different Asasantin ER extended release (ER) 200 mg dipyridamole/25 mg ASA formulations in healthy male and female volunteers.

    Study Document Trial synopsis 9.144 english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.146
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase IV
    Study Title

    Comparison of pharmacokinetics of dipyridamole administered as Aggrenox® (dipyridamole extended release plus aspirin) capsule versus dipyridamole immediate release plus aspirin following alteration of stomach pH by the prior administration of a proton-pump inhibitor: An open-label 2-way randomized cross-over study in healthy male and female subjects age 40-65.

    Study Document Trial synopsis 9.146_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.149
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a new Asasantin capsule formulation (extended release combination 200 mg Dipyridamole/25 mg ASA) compared to the commercially available Asasantin capsule formulation (Aggrenox®; extended release combination 200 mg dipyridamole/25 mg ASA) following multiple oral administration at steady state after a run-inphase (Persantine ER BID for 2 days each: 25 mg, 50 mg, 100 mg; 150 mg [Persantine®]; 200 mg Dipyridamole/25 mg ASA [AsasantinER]) - an open label, randomized, multiple-dose, two-way crossover,change-over study in healthy male and female volunteers.

    Study Document Trial synopsis 9.149 english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.158
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of dipyridamole after Asasantin (extended release 200 mg dipyridamole/25mg ASA) in 3 experimental formulations (given b.i.d. over 3 or 5 days, respectively) relative to the standard formulation in 16 healthy female and male subjects. Intraindividual comparison, randomised, open.

    Study Document Trial synopsis 9.158 english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.163
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of dipyridamole of Asasantin p.o. (extended release 200 mg dipyridamole/25 mg ASA) in three experimental formulations (given BID over 3 days each) relative to the standard formulation aftera run-in phase (Persantine ER BID for 2 days each: 25 mg, 50 mg,100 mg; 150 mg [Persantine®]; 200 mg Persantine /25 mg ASA [Asasantin ER] in healthy male subjects. Four-way, change-over,randomised, open

    Study Document Trial synopsis 9.163 english

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