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A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping

Trial Profile

A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Dec 2020

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At a glance

  • Drugs Clazosentan (Primary)
  • Indications Cerebral vasospasm
  • Focus Registrational; Therapeutic Use
  • Acronyms CONSCIOUS-2
  • Sponsors Actelion Pharmaceuticals
  • Most Recent Events

    • 23 Nov 2020 According to an Idorsia Pharmaceuticals Media Release, the company expects to file New Drug Application (NDA) with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in the first half of 2021 and make the full results available through scientific publication.
    • 23 Nov 2020 According to an Idorsia Pharmaceuticals Media Release, further analysis is ongoing including additional pooled analysis of data from CONSCIOUS-2 and CONSCIOUS-3 studies.
    • 23 Nov 2020 Positive top-line results from pre-planned pooled analysis from CONSCIOUS-2 and CONSCIOUS-3 studies presented in an Idorsia Pharmaceuticals Media Release.
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