A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK-4305 in Patients With Primary Insomnia - Study B

Trial Profile

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK-4305 in Patients With Primary Insomnia - Study B

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jul 2017

At a glance

  • Drugs Suvorexant (Primary)
  • Indications Insomnia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • 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.
    • 13 Jun 2012 Primary endpoint 'Wake-time-after-sleep-onset' has been met.
    • 13 Jun 2012 Primary endpoint 'Total-sleep-time' has been met.
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