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

Trial Profile

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 31 Dec 2018

At a glance

  • Drugs Omega-3 phospholipid (Primary)
  • Indications Hypertriglyceridaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms TRILOGY 1
  • Sponsors Acasti Pharma
  • Most Recent Events

    • 31 Dec 2018 According to an Acasti Pharma media release, the two Phase 3 TRILOGY trials (TRILOGY 1 & 2) have now exceeded 65% patient randomization, and more than 100 patients have completed their 6 month treatment plan. In total, about 1,500 patients have been enrolled till date.
    • 20 Dec 2018 According to an Acasti Pharma media release, as of December 19, 2018, more than 60% of the required total of 500 patients for the two studies have been randomized. Additional patients may still be added to this TRILOGY program as needed by early next year to achieve final randomization targets. The company expects to report top-line results from these studies before the end of 2019.
    • 20 Dec 2018 According to an Acasti Pharma media release, the comapny has reached the enrollment targets in these TRILOGY (1 and 2) phase 3 trials. Total 1,450 patients have been enrolled at 150 clinical sites across the U.S., Canada and Mexico.
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