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Clinical trials for Esmirtazapine

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    6 result(s) found for: Esmirtazapine. Displaying page 1 of 1.
    EudraCT Number: 2007-002523-33 Sponsor Protocol Number: 21108 Start Date*: 2007-10-31
    Sponsor Name:NV Organon
    Full Title: A double-blind, randomized, parallel group, placebo-controlled sleep laboratory efficacy and safety study with Org 50081 in elderly subjects with chronic primary insomnia
    Medical condition: Primary insomnia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036701 Primary insomnia LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) DK (Completed) GB (Completed) HU (Completed) CZ (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-003636-35 Sponsor Protocol Number: 176005 Start Date*: 2007-10-15
    Sponsor Name:NV Organon
    Full Title: A randomized long-term safety study of Org 50081 in elderly outpatients with chronic primary insomnia examining the effects of 1.5 mg or 3.0 mg of Org 50081
    Medical condition: Primary insomnia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036701 Primary insomnia LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: FI (Completed) NL (Completed) SE (Completed) DE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2004-000472-14 Sponsor Protocol Number: 177001 Start Date*: 2004-11-17
    Sponsor Name:Organon Hungary Ltd.
    Full Title: A multicenter, randomized, parallel-group, double- blind, placebo-controlled trial to evaluate the efficacy and safety of four different doses of Org 50081 in the treatment of moderate to severe va...
    Medical condition: moderate to severe vasomotor symptoms associated with the menopause
    Disease: Version SOC Term Classification Code Term Level
    7.0 10020411 LLT
    Population Age: Adults Gender: Female
    Trial protocol: HU (Completed) CZ (Completed) SK (Completed) ES (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-005237-10 Sponsor Protocol Number: 176003 Start Date*: 2009-01-28
    Sponsor Name:NV Organon
    Full Title: A twenty-six weeks, open-label extension trial to evaluate safety and efficacy of Org 50081 in outpatients with chronic primary insomnia who completed clinical trial protocol 21106.
    Medical condition: Primary insomnia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036701 Primary insomnia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) SE (Prematurely Ended) DE (Completed) FR (Prematurely Ended) NL (Completed) HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-000469-36 Sponsor Protocol Number: 46101 Start Date*: 2004-11-08
    Sponsor Name:NV Organon
    Full Title: A multicenter, randomized, parallel-group, double-blind, placebo-controlled trial to evaluate the efficacy and safety of four different doses of Org 50081 in the treatment of moderate to severe vas...
    Medical condition: moderate to severe vasomotor symptoms associated with the menopause
    Disease: Version SOC Term Classification Code Term Level
    7.0 10020411 LLT
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed) FI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-005236-92 Sponsor Protocol Number: 21106 Start Date*: 2008-04-22
    Sponsor Name:NV Organon
    Full Title: 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.
    Medical condition: Primary insomnia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036701 Primary insomnia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) FR (Completed) HU (Prematurely Ended) SE (Completed) NL (Completed) DE (Completed) BE (Completed) IT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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