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Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels greater than or equal to 500 mg/dL and less than or equal to 2000 mg/dL.

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Trial Profile

Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels greater than or equal to 500 mg/dL and less than or equal to 2000 mg/dL.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Apr 2022

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At a glance

  • Drugs Ethyl eicosapentaenoic acid (Primary)
  • Indications Hypertriglyceridaemia
  • Focus Biomarker; Pharmacodynamics; Registrational; Therapeutic Use
  • Acronyms MARINE
  • Sponsors Amarin Corporation

Most Recent Events

  • 16 Jun 2020 According to an Amarin Corporation media release,company has a settlement agreement with Apotex that resolves patent litigation that would have resulted from the previously disclosed ANDA filed by Apotex and amended in May 2020 seeking approval of a generic form of VASCEPA based on the MARINE study. As part of the settlement agreement, Apotex may not sell a generic of VASCEPA in the US until August 9, 2029 or earlier under certain customary circumstances.
  • 28 Nov 2018 According to a Cardax Pharmaceuticals media release, Paresh N. Soni, M.D., Ph.D led the development of this clinical trial and regulatory strategy.
  • 01 Nov 2016 Results (n=215) of subgroup analyses of MARINE and ANCHOR trials published in the American Journal of Cardiology (2016).

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