The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia

Trial Profile

The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Sep 2017

At a glance

  • Drugs Volanesorsen (Primary)
  • Indications Hypertriglyceridaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms COMPASS
  • Sponsors Ionis Pharmaceuticals
  • Most Recent Events

    • 12 Sep 2017 According to an Akcea Therapeutics media release, based on the data from the Phase 3 APPROACH and COMPASS studies, the company has filed a New Drug Submission (NDS) to Health Canada for volanesorsen for the treatment of familial chylomicronemia syndrome (FCS) and received a priority review for the volanesorsen NDS from Health Canada.
    • 31 Aug 2017 According to an Akcea Therapeutics media release, based on the data from the Phase 3 APPROACH and COMPASS studies, company has submitted a new drug application (NDA) to the US FDA for volanesorsen for the treatment of familial chylomicronemia syndrome (FCS).
    • 08 Aug 2017 According to an Akcea Therapeutics media release, the company is on track to file for regulatory approval in the U.S. and Canada in September 2017.
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