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CS-747S PhaseIII trial - A Double-blind Study of CS-747S Versus Clopidogrel Sulfate in Patients with Thrombotic Stroke Having Risk Factors for Stroke Recurrence

Trial Profile

CS-747S PhaseIII trial - A Double-blind Study of CS-747S Versus Clopidogrel Sulfate in Patients with Thrombotic Stroke Having Risk Factors for Stroke Recurrence

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jan 2024

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At a glance

  • Drugs Prasugrel (Primary) ; Clopidogrel
  • Indications Acute coronary syndromes; Stroke
  • Focus Registrational; Therapeutic Use
  • Acronyms PRASTRO-III
  • 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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