A 6-month, double-blind, randomized, placebo-controlled, parallel group outpatient trial, investigating the efficacy and safety of Org 50081 in adult patients with chronic primary insomnia.

Trial Profile

A 6-month, double-blind, randomized, placebo-controlled, parallel group outpatient trial, investigating the efficacy and safety of Org 50081 in adult patients with chronic primary insomnia.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2014

At a glance

  • Drugs Esmirtazapine (Primary)
  • Indications Insomnia
  • Focus Registrational; Therapeutic Use
  • Acronyms AQUAMARINE
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 15 Mar 2012 This trial is recruiting in United Kingdom and France and prematurely ended in Sweden (Parent trial; EudraCT2007-005236-92).
    • 15 Mar 2012 Planned number of patients changed from 186 to 440 as reported by EudraCT. (Parent trial; EudraCT2007-005236-92)
    • 09 Dec 2009 Actual patient number changed from 452 to 460 as reported by ClinicalTrials.gov. record NCT00631657.
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