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Clinical trials for Custodiol®-N

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   44393   clinical trials with a EudraCT protocol, of which   7405   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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    7 result(s) found for: Custodiol®-N. Displaying page 1 of 1.
    EudraCT Number: 2012-003776-40 Sponsor Protocol Number: CL-N-CSM-AV-III/05/12 Start Date*: 2013-11-08
    Sponsor Name:Dr. Franz Köhler Chemie GmbH
    Full Title: A Prospective Randomized Double Blind Multicenter Phase III Study Comparing two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N versus Custodiol
    Medical condition: Patients with aortic valve disease and has to undergo aortic valve surgery +/- bypass surgery.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-005503-13 Sponsor Protocol Number: 1.0_Custodiol Start Date*: 2015-02-16
    Sponsor Name:Essen University Hospital, University of Essen, Klinik für Allgemein-, Viszeral- und Transplantationschirugie
    Full Title: A prospective randomized single blind monocenter phase II study of organ perfusion with Custodiol-N compared with Custodiol solution in living donor kidney transplantation
    Medical condition: kidney preservation by Custodiol-N or Custodiol solution before living related kidney transplantation
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004865 10023438 Kidney transplant LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-001112-29 Sponsor Protocol Number: CL-N-HTX-CSM-III/04/12 Start Date*: 2015-07-27
    Sponsor Name:Dr. Franz Köhler Chemie GmbH
    Full Title: A Prospective, randomized, single blind, multicenter Phase III study of organ perfusion with Custodiol-N solution compared with Custodiol solution in Heart transplantation
    Medical condition: Patients that has to undergo (is suitable for) a heart transplantation
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002198-20 Sponsor Protocol Number: CLNKLPTXIII07AT17 Start Date*: 2018-11-28
    Sponsor Name:Dr. Franz Köhler Chemie GmbH
    Full Title: A Prospective, randomized, single blind, multicentre Phase III study on organ preservation with Custodiol-N solution compared with Custodiol solution in organ transplantation (kidney, liver and pan...
    Medical condition: patients who will undergo kidney, liver or kidney-pancreatic transplantation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001872-12 Sponsor Protocol Number: CL-N-LTX-III/08-ESP/19 Start Date*: 2021-12-28
    Sponsor Name:Dr. Franz Köhler Chemie GmbH
    Full Title: A Prospective, randomized, single blind, multicenter Phase III study on organ preservation with Custodiol-N solution compared with Custodiol solution in liver transplantation
    Medical condition: Liver transplantation.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10024714 Liver transplant PT
    21.0 10042613 - Surgical and medical procedures 10024716 Liver transplantation LLT
    21.1 10042613 - Surgical and medical procedures 10050434 Prophylaxis against liver transplant rejection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-005992-81 Sponsor Protocol Number: CL-N-CSM-III/01/08 Start Date*: 2011-03-21
    Sponsor Name:Dr. F. Köhler Chemie GmbH
    Full Title: A Prospective Randomized Double Blind Multicenter Phase III Study Comparing two Methods of Cardioplegia in Coronary Artery Bypass Surgery Custodiol-N versus Custodiol
    Medical condition: The study population will be selected from both genders with coronary artery disease (CAD) who are to undergo cardiopulmonary bypass for coronary artery bypass surgery. The ratio of incidence for b...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10007541 - Cardiac disorders 10011078 Coronary artery disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-001795-34 Sponsor Protocol Number: CL-N-HTX-Paed-II/10/20 Start Date*: 2023-01-30
    Sponsor Name:Dr. Franz Köhler Chemie GmbH
    Full Title: A prospective randomized single blind multicenter phase II study of organ perfusion with Custodiol-N compared with Custodiol in heart transplantation in children
    Medical condition: Preservation of hearts prior to heart transplantation in children
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10019314 Heart transplant PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing)
    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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