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.
Phase of Trial: Phase III
Latest Information Update: 08 Oct 2018
At a glance
- Drugs Esmirtazapine (Primary)
- Indications Insomnia
- Focus Registrational; Therapeutic Use
- Acronyms AQUAMARINE
- Sponsors Merck Sharp & Dohme
- 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.