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Clinical trials for remimazolam

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   44335   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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    5 result(s) found for: remimazolam. Displaying page 1 of 1.
    EudraCT Number: 2020-003689-37 Sponsor Protocol Number: RC20_0319 Start Date*: 2020-10-27
    Sponsor Name:CHU de Nantes
    Full Title: REmimazolam infusion in the context of Hypnotic Shortage in the Critical care Unit during the pandemic of COVID-19. The non-randomized, non-controlled, pilot, open, mono-centric REHSCU study.
    Medical condition: general anaesthesia in ICU
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10021723 Induction and maintenance of anaesthesia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-004565-24 Sponsor Protocol Number: CNS7056-011 Start Date*: 2015-06-22
    Sponsor Name:PAION UK Limited
    Full Title: A Randomized, Single-blind, Propofol-controlled Phase III Study Evaluating the Efficacy and Safety of Remimazolam in General Anesthesia in Adult Patients Undergoing Cardiac Surgery, Including Follo...
    Medical condition: Anesthesia in adult patients undergoing cardiac surgery.
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004865 10021722 Induction and maintenance anaesthesia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Prematurely Ended) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-000174-29 Sponsor Protocol Number: CNS7056-022 Start Date*: 2018-07-25
    Sponsor Name:PAION UK Limited
    Full Title: Phase III confirmatory efficacy and safety trial of remimazolam (CNS7056) compared with propofol for intravenous anaesthesia during elective surgery
    Medical condition: Induction and maintenance of general anaesthesia (GA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10018061 General anesthesia LLT
    20.0 100000004865 10054434 Induction and maintenance of anesthesia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Completed) GB (Prematurely Ended) NL (Prematurely Ended) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001113-32 Sponsor Protocol Number: CNS7056-010 Start Date*: 2013-08-02
    Sponsor Name:PAION UK Limited
    Full Title: A Randomized, Single-blind Phase II Study Evaluating the Efficacy, Safety and Pharmacokinetics of Remimazolam in General Anesthesia in Adult Patients Undergoing Cardiac Surgery, Including Follow-up...
    Medical condition: Anaesthesia in adult patients undergoing cardiac surgery.
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004865 10021722 Induction and maintenance anaesthesia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-004118-37 Sponsor Protocol Number: CNS7056-026 Start Date*: 2021-08-31
    Sponsor Name:PAION UK Ltd [...]
    1. PAION UK Ltd
    2. Acacia Pharma Ltd.
    Full Title: A Phase 2/3, prospective, open-label trial evaluating the efficacy, safety, and pharmacokinetics of remimazolam for intravenous sedation in paediatric patients undergoing diagnostic and/or therapeu...
    Medical condition: Paediatric procedural sedation
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004865 10083924 Sedation procedure LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
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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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