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Clinical trials for Eisenmenger's syndrome

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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    9 result(s) found for: Eisenmenger's syndrome. Displaying page 1 of 1.
    EudraCT Number: 2012-004411-31 Sponsor Protocol Number: AC-055-308 Start Date*: 2013-02-01
    Sponsor Name:ACTELION PHARMACEUTICALS LTD.
    Full Title: Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome.
    Medical condition: Eisenmenger Syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10058554 Eisenmenger's syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) BG (Completed) GB (Completed) DE (Completed) AT (Completed) PT (Completed) ES (Completed) HU (Completed) CZ (Completed) RO (Completed) PL (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2006-004705-26 Sponsor Protocol Number: CRO529 Start Date*: 2007-05-10
    Sponsor Name:Imperial College London
    Full Title: Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology
    Medical condition: Eisenmenger Syndrome (pulmonary hypertension due to congenital heart disease)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10058554 Eisenmenger's syndrome LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-003335-33 Sponsor Protocol Number: AC-055-305 Start Date*: 2013-02-27
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome.
    Medical condition: Eisenmenger Syndrome
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10058554 Eisenmenger's syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) BG (Completed) BE (Completed) DE (Completed) PT (Completed) NL (Completed) AT (Completed) ES (Completed) HU (Completed) CZ (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2007-002774-64 Sponsor Protocol Number: HP 3.1 Start Date*: 2007-12-04
    Sponsor Name:Deutsches Herzzentrum Berlin, Kompetenznetz Angeborene Herzfehler
    Full Title: Therapy of PAH – Treatment with Sildenafil in Eisenmenger Patients
    Medical condition: Patients with pre-existing congenital heart disease may develop Eisenmenger physiology (EP), characterized by development of pulmonary arterial hypertension and intracardiac right to left shunt. Th...
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-000021-57 Sponsor Protocol Number: 01000 Start Date*: 2006-03-10
    Sponsor Name:Rigshospitalet
    Full Title: Bosentan and Sildenfil for patients with Eisenmenger syndrome
    Medical condition: Eisenmengers syndrome is condition with severe pulmonary arterial hypertension due to a shunting of blood from the left side of the heart to the right side of the heart. When the pressure in the pu...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2014-000091-25 Sponsor Protocol Number: 2014GU001B Start Date*: 2014-09-01
    Sponsor Name:Royal Brompton and Harefield NHS Foundation Trust
    Full Title: A single-centre, placebo-controlled, double-blinded, randomized, cross-over study of Iloprost (Ventavis®) in patients with Eisenmenger syndrome
    Medical condition: Pulmonary Arterial Hypertension Eisenmenger syndrome
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004855 10037405 Pulmonary hypertension primary LLT
    17.0 100000004855 10037406 Pulmonary hypertension secondary LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-002754-74 Sponsor Protocol Number: 67896062PAH1013 Start Date*: Information not available in EudraCT
    Sponsor Name:ACTELION Pharmacteuticals Ltd.
    Full Title: A multicenter, open-label, single-arm study to assess the pharmacokinetics and safety of macitentan in children aged 1 month to <2 years with pulmonary arterial hypertension
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-021825-11 Sponsor Protocol Number: AC-052-373 Start Date*: 2011-04-28
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with...
    Medical condition: Pulmonary arterial hypertension (PAH) in children
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064908 Associated with (APAH) LLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064909 Idiopathic (IPAH) LLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064910 Familial (FPAH) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) HU (Completed) DE (Completed) ES (Completed) CZ (Completed) FR (Ongoing) IT (Completed) BG (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-004106-16 Sponsor Protocol Number: AC-052-375 Start Date*: Information not available in EudraCT
    Sponsor Name:Actelion pharmaceuticals Ltd
    Full Title: A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children wit...
    Medical condition: Pulmonary arterial hypertension (PAH) in children
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064908 Associated with (APAH) LLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064909 Idiopathic (IPAH) LLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064910 Familial (FPAH) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) FR (Ongoing) PT (Completed) BG (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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