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A Phase 3, Multi-center, Multi-national, Placebo-controlled, Randomized, Double-blind 26 Week Study to Assess the Safety and Efficacy of CaPre in Patients With Severe Hypertriglyceridemia

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Trial Profile

A Phase 3, Multi-center, Multi-national, Placebo-controlled, Randomized, Double-blind 26 Week Study to Assess the Safety and Efficacy of CaPre in Patients With Severe Hypertriglyceridemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Omega-3 phospholipid (Primary)
  • Indications Hyperlipidaemia; Hypertriglyceridaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms TRILOGY 2
  • Sponsors Acasti Pharma

    • Most Recent Events

    • 31 Aug 2020 According to an Acasti Pharma media release, the company has decided not to host a conference call today as previously disclosed, as there is no additional material information at this time that can be shared beyond what is contained in this press release.
    • 31 Aug 2020 According to an Acasti Pharma media release, the company plans to pool together the results from the two studies (Trilogy 1 & 2) to better understand this phenomenon in post-hoc explorations. Clinical advisors of the study will review the full dataset once it is available, and will complete the full data analyses as contemplated in the Statistical Analysis Plan, including the secondary and exploratory endpoints and the pooling of the data from TRILOGY 1 and 2.
    • 31 Aug 2020 According to an Acasti Pharma media release, based on the results of the study the company will not file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for patients with severe hypertriglyceridemia, and does not plan to conduct additional clinical trials for CaPre.
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