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Clinical trials for Fontan procedure

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    3 result(s) found for: Fontan procedure. Displaying page 1 of 1.
    EudraCT Number: 2016-004433-24 Sponsor Protocol Number: 59498 Start Date*: 2017-05-17
    Sponsor Name:Leids Universitair Medisch Centrum
    Full Title: ACE inhibition in Fontan patients: its effect on body fluid regulation.
    Medical condition: Patients with univentricular hearts palliated by the Fontan procedure
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-002610-76 Sponsor Protocol Number: 39039039CHD3001/BAY59-7939-18226 Start Date*: 2016-09-21
    Sponsor Name:Janssen-Cilag International N.V
    Full Title: A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years ...
    Medical condition: thromboprophylaxis
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10040729 Single ventricle LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) ES (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-004828-11 Sponsor Protocol Number: RECHMPL18_0038_prom_7574 Start Date*: 2022-01-10
    Sponsor Name:University Hospital of Montpellier
    Full Title: Phosphodiesterase-type 5 inhibitors in adult and adolescent patients with univentricular heart disease: a multi-center, randomized, double blind phase III study
    Medical condition: adult and adolescent patients with univentricular heart diseases and pulmonary arterial pressure
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
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    Query did not match any studies.
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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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