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HPS-4/TIMI 65/ORION-4: A Double-blind Randomized Placebo-controlled Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Atherosclerotic Cardiovascular Disease

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Trial Profile

HPS-4/TIMI 65/ORION-4: A Double-blind Randomized Placebo-controlled Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Atherosclerotic Cardiovascular Disease

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2023

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At a glance

  • Drugs Inclisiran (Primary)
  • Indications Atherosclerosis; Cardiovascular disorders; Hypercholesterolaemia; Myocardial ischaemia; Stroke
  • Focus Adverse reactions; Registrational
  • Acronyms HPS-4/TIMI 65/ORION-4; ORION-4
  • Sponsors Novartis; Novartis Pharmaceuticals

    • Most Recent Events

    • 03 Aug 2021 According to an Alnylam Pharmaceuticals media release, Novartis announced that the resubmission to the FDA for the inclisiran NDA to address the Complete Response Letter (CRL) was filed with an action date of January 1, 2022.
    • 28 Apr 2021 Planned primary completion date changed from 1 Dec 2024 to 1 Jul 2026.
    • 29 Mar 2021 According to an Alnylam Pharmaceuticals media release, response to U.S. Complete Response Letter to be submitted Q2-Q3 2021.
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