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A double-blind study to assess the efficacy and safety of clazosentan in reducing cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage treated by endovascular coiling

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Trial Profile

A double-blind study to assess the efficacy and safety of clazosentan in reducing cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage treated by endovascular coiling

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2023

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At a glance

  • Drugs Clazosentan (Primary)
  • Indications Cerebral vasospasm
  • Focus Registrational; Therapeutic Use
  • Acronyms Coiling study
  • Sponsors Actelion Pharmaceuticals; Idorsia Pharmaceuticals
  • Most Recent Events

    • 07 Dec 2023 According to an Idorsia Pharmaceuticals media release, based on scientific and clinical data from an extensive Japanese Phase 3 program (JapicCTI163369,JapicCTI163368), the PIVLAZ (clazosentan sodium) 150 mg has received marketing approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) securing.
    • 01 Dec 2022 Results of pooled analysis from two studies: apicCTI-163368 and JapicCTI-163369 published in the Journal of Neurosurgery
    • 26 Apr 2022 Status changed from active, no longer recruiting to completed.
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