A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Long Term Safety Study of MK-4305 in Patients With Primary Insomnia

Trial Profile

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Long Term Safety Study of MK-4305 in Patients With Primary Insomnia

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Oct 2014

At a glance

  • Drugs Suvorexant (Primary)
  • Indications Insomnia
  • Focus Adverse reactions; Pharmacogenomic; Registrational
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 08 Nov 2012 Results from this trial were used to support an NDA for suvorexant, which was accepted for review by the FDA in November 2012.
    • 10 Sep 2012 Results from the 12-month treatment phase of the trial were presented at SLEEP 2012 according to a Merck media release.
    • 10 Sep 2012 Results have been presented at the 21st Congress of the European Sleep Research Society (ESRS) according to a Merck media release. Results were also reported in the media release.
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