Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Active Reference, Parallel-Group Polysomnography Study to Assess the Efficacy and Safety of a 16-Day Oral Administration of ACT-078573 [almorexant] in Adult Subjects With Chronic Primary Insomnia.

Trial Profile

Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Active Reference, Parallel-Group Polysomnography Study to Assess the Efficacy and Safety of a 16-Day Oral Administration of ACT-078573 [almorexant] in Adult Subjects With Chronic Primary Insomnia.

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Mar 2016

At a glance

  • Drugs Almorexant (Primary) ; Zolpidem
  • Indications Insomnia
  • Focus Registrational; Therapeutic Use
  • Acronyms RESTORA; RESTORA-1
  • Sponsors Actelion Pharmaceuticals
  • Most Recent Events

    • 15 Mar 2012 According to EudraCT this trial is ongoing in Slovakia, Spain, United Kingdom, France and NCT reports trial status as completed. I have retained NCT because it is consistent with MR.
    • 15 Mar 2012 Additional location (England) added as reported by European Clinical Trials Database.
    • 05 Feb 2010 Actual end date changed from Oct 2009 to Nov 2009 as reported by ClinicalTrials.gov.
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