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Clinical trials for Blalock Taussig shunt

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
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    • 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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    4 result(s) found for: Blalock Taussig shunt. Displaying page 1 of 1.
    EudraCT Number: 2004-001841-14 Sponsor Protocol Number: PICOLO Start Date*: 2005-01-10
    Sponsor Name:SANOFI-SYNTHELABO
    Full Title: Dose-ranging pharmacodynamic assessment of platelet aggregation inhibition with clopidogrel in children of Blalock-Taussig shunt age categories (neonates and infants/toddlers)
    Medical condition: neonates or infants/toddlers at risk of thrombosis
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) BE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-000946-38 Sponsor Protocol Number: EFC5314 Start Date*: 2007-01-24
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: International randomized double blind clinical study evaluating the efficacy and safety of clopidogrel 0.2mg/kg once daily versus placebo in neonates and infants with cyanotic congenital heart dise...
    Medical condition: Neonates or infants (age less than or equal to 92 days at the time of randomization) with systemic to pulmonary arterial shunt for palliation of cyanotic congenital heart disease.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10019273 Heart disease congenital LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DE (Completed) FI (Completed) SE (Completed) DK (Completed) PT (Completed) FR (Completed) HU (Completed) IT (Completed) NL (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-000134-22 Sponsor Protocol Number: MDCO-CAN-15-01 Start Date*: 2021-01-14
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: A Prospective, Open-Label, Single-Arm, Multi-Center Study to Assess The Pharmacokinetics/Pharmacodynamics (PK/PD) AND Safety Of Different Cangrelor Doses In Neonatal Subjects At Risk Of Thrombosis.
    Medical condition: Postoperative neonatal cardiac subjects who are undergoing surgery for placement of systemic-to pulmonary artery palliative shunts (e.g., Blalock-Taussig or central shunt), right ventricle to pulmo...
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000475-90 Sponsor Protocol Number: DU176b-C-U313 Start Date*: 2018-03-27
    Sponsor Name:Daiichi Sankyo Inc
    Full Title: AN OPEN-LABEL, RANDOMISED, PARALLEL-GROUP, MULTICENTRE, OBSERVATIONAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF EDOXABAN TOSYLATE IN CHILDREN FROM 38 WEEKS GESTATIONAL AGE TO LESS THAN 18 YEARS OF A...
    Medical condition: thromboembolism
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004866 10043566 Thromboembolism LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed) DE (Completed) ES (Completed) AT (Completed) FR (Completed) PL (Completed) HR (Completed) IT (Ongoing)
    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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