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CS-747S PhaseIII trial -Double-blind study of CS-747S versus clopidogrel bisulfate in elderly and/or low body weight patients with ischemic cerebrovascular accident-

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Trial Profile

CS-747S PhaseIII trial -Double-blind study of CS-747S versus clopidogrel bisulfate in elderly and/or low body weight patients with ischemic cerebrovascular accident-

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Jan 2024

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At a glance

  • Drugs Prasugrel (Primary) ; Clopidogrel
  • Indications Stroke
  • Focus Adverse reactions; Registrational
  • Acronyms PASTRO II
  • Sponsors Daiichi Sankyo Company; Ube Industries

    • Most Recent Events

    • 24 Dec 2021 According to a Daiichi Sankyo Company media release, the company has obtained a supplemental new drug application approval for additional indication and dosage and administration of the antiplatelet agents "Efient 3.75 mg Tablets" and "Efient 2.5 mg Tablets" in Japan.
    • 15 Dec 2020 According to a Daiichi Sankyo Company media release, the supplemental application is based on the results of a phase 3 study in thrombotic stroke patients in Japan (PRASTRO-III study), as well as other phase 3 studies in Japan targeting patients with ischemic cerebrovascular disease (PRASTRO-I and PRASTRO-II studies).
    • 15 Dec 2020 According to a Daiichi Sankyo Company media release, a supplemental application for the antiplatelet agent, prasugrel hydrochloride (hereafter, prasugrel), was filed in Japan to expand the indication for prevention of recurrence of ischemic stroke as a partial change in items of the pharmaceutical manufacturing and marketing approval for prasugrel.

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