Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Pulmonary 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
  • 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   43881   clinical trials with a EudraCT protocol, of which   7295   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    49 result(s) found for: Pulmonary Shunt. Displaying page 1 of 3.
    1  2  3  Next»
    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: 2008-004999-53 Sponsor Protocol Number: LTS10916 Start Date*: 2009-02-06
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: Long-term safety study in patients included in CLARINET study with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt and for whom the shunt is still in place at...
    Medical condition: Patients at one year of age who are included in CLARINET, with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt, and for whom the shunt is still in place.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10019273 Heart disease congenital LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: PT (Completed) HU (Completed) ES (Completed) BE (Completed) DE (Completed) FR (Completed) IT (Completed) GB (Completed) Outside EU/EEA
    Trial results: View results
    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: 2004-000625-30 Sponsor Protocol Number: INOT22 Start Date*: 2004-07-21
    Sponsor Name:INO Therapeutics
    Full Title: Comparison of Supplemental Oxygen and Nitric Oxide for Inhalation Plus Oxygen in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator Testing
    Medical condition: : Nitric Oxide for inhalation at 800ppm, plus 100% O2, to be used to assess pulmonary vaso reactivity during Pulmonary Vasodilator Testing
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed)
    Trial results: View results
    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: 2020-001108-40 Sponsor Protocol Number: MK-5475-007 Start Date*: 2021-04-08
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10065150 Associated with pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) FR (Trial now transitioned) PL (Trial now transitioned) IT (Ongoing) GR (Trial now transitioned) BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-005898-29 Sponsor Protocol Number: RRK2962 Start Date*: 2008-07-04
    Sponsor Name:University Hospital Birmingham
    Full Title: The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation
    Medical condition: Patients with a Fontan circulation (that is they have had a Fontan operation for a functionally univentricular heart)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045545 Univentricular heart LLT
    9.1 10065950 Cavopulmonary anastomosis LLT
    9.1 10037456 Pulmonary vascular resistance abnormality LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-001710-32 Sponsor Protocol Number: 2006-101 Start Date*: 2006-07-05
    Sponsor Name:Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital Rigshospitalet
    Full Title: PeRioperative OXygen fraction – effect on surgical site Infection and pulmonary complications after abdominal surgery. (The PROXI-study)
    Medical condition: Laparotomy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2019-002533-11 Sponsor Protocol Number: AC-055-315 Start Date*: 2020-06-17
    Sponsor Name:ACTELION Pharmacteuticals Ltd.
    Full Title: A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Toler...
    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: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) CZ (Ongoing) HU (Ongoing) SE (Ongoing) GB (GB - no longer in EU/EEA) DK (Ongoing) NL (Ongoing) PL (Ongoing) PT (Ongoing) BE (Ongoing) NO (Completed) SK (Ongoing) AT (Ongoing) IT (Ongoing) BG (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-001187-33 Sponsor Protocol Number: ROR-PH-301(APD811-301) Start Date*: 2019-03-18
    Sponsor Name:United Therapeutics Corporation
    Full Title: A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients (ADVANCE Outcomes)
    Medical condition: pulmonary arterial hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10077731 Pulmonary hypertension WHO functional class I LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) SE (Prematurely Ended) GB (GB - no longer in EU/EEA) HU (Ongoing) DK (Ongoing) PL (Ongoing) CZ (Ongoing) BE (Ongoing) BG (Ongoing) NL (Ongoing) GR (Temporarily Halted) PT (Ongoing) IT (Ongoing) HR (Ongoing) RO (Ongoing)
    Trial results: (No results available)
    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: (No results available)
    EudraCT Number: 2013-003462-14 Sponsor Protocol Number: AC-055-310 Start Date*: 2013-12-10
    Sponsor Name:ACTELION Pharmaceuticals Ltd.
    Full Title: A multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PA...
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-004971-42 Sponsor Protocol Number: RVT-1201-2002 Start Date*: 2021-10-26
    Sponsor Name:Altavant Sciences GmbH
    Full Title: A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension
    Medical condition: Pulmonary Arterial Hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) LV (Prematurely Ended) BE (Completed) CZ (Prematurely Ended) PL (Prematurely Ended) IT (Prematurely Ended) BG (Prematurely Ended) ES (Ongoing) AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2022-000478-25 Sponsor Protocol Number: MK-7962-008 Start Date*: 2023-02-20
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children from 1 to Less Than 18 Years of Age With PAH on Standard...
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10037403 Pulmonary hypertension NOS LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-003320-23 Sponsor Protocol Number: AC-055H301 Start Date*: 2017-10-11
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects.
    Medical condition: Congenital Heart Failure
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10045545 Univentricular heart PT
    21.1 10042613 - Surgical and medical procedures 10065950 Cavopulmonary anastomosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed) FR (Completed) PL (Completed) IE (Completed) CZ (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: 2006-002235-25 Sponsor Protocol Number: A1481131 Start Date*: 2006-12-14
    Sponsor Name:Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United Kingdom
    Full Title: A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    9.0 10064911 LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) FI (Prematurely Ended) SK (Completed) Outside EU/EEA
    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: 2014-003952-29 Sponsor Protocol Number: BAY63-2521/15681 Start Date*: 2015-08-25
    Sponsor Name:Bayer AG
    Full Title: Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (...
    Medical condition: Hypertension, Pulmonary
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) IT (Ongoing) GB (Completed) DE (Ongoing) FR (Ongoing) ES (Prematurely Ended) PL (Completed) Outside EU/EEA BE (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-002022-20 Sponsor Protocol Number: NL61945.029.17 Start Date*: 2017-07-27
    Sponsor Name:VU University Medical Center
    Full Title: The effect of inspiratory oxygen fraction on the ratio of partial arterial oxygen pressure and inspiratory oxygen fraction (PaO2/FiO2 ratio) in mechanically ventilated patients with and without mil...
    Medical condition: We investigate the PaO2/FiO2 ratio in patients without and with mild to moderate ARDS
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10003083 ARDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon May 20 00:30:36 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA