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-
Latest Information Update: 09 Jan 2024
At a glance
- Drugs Prasugrel (Primary) ; Clopidogrel
- Indications Stroke
- Focus Adverse reactions; Registrational
- Acronyms PASTRO II
- Sponsors Daiichi Sankyo Company; Ube Industries
- 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.