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Clinical trials for Cardiac and vascular disorders congenital

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   44412   clinical trials with a EudraCT protocol, of which   7421   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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    28 result(s) found for: Cardiac and vascular disorders congenital. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2016-002157-38 Sponsor Protocol Number: 57911 Start Date*: 2017-09-14
    Sponsor Name:Radboud University Medical Center
    Full Title: Treatment of congenital vascular malformations using Sirolimus: improving quality of Life
    Medical condition: congenital vascular malformation : Vascular malformations can involve lymphatic vessels, capillaries, veins and arteries or even combinations. These vascular malformations are present at birth an...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000005125 10047091 Vascular malformations and acquired anomalies HLT
    20.0 100000158692 10047090 Vascular malformation peripheral LLT
    20.0 10017947 - Gastrointestinal disorders 10070181 Gastrointestinal vascular malformation PT
    20.0 10010331 - Congenital, familial and genetic disorders 10074979 Vascular malformation PT
    Population Age: Infants and toddlers, Children, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2012-004583-22 Sponsor Protocol Number: 548.12 Start Date*: 2012-10-20
    Sponsor Name:OSPEDALE PEDIATRICO BAMBINO GESU' DI ROMA
    Full Title: Verification of the effectiveness of intravenous sildenafil compared to other pulmonary vasodilators used in the test vessel reactivity of pulmonary
    Medical condition: Subjects in children with congenital heart disease surgery or not, with echocardiographic signs of pulmonary hypertension followed at the Pediatric Cardiology Centre of the Mediterranean or reporte...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10047065 - Vascular disorders 10047065 Vascular disorders SOC
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-001784-77 Sponsor Protocol Number: ML6721 Start Date*: 2012-05-07
    Sponsor Name:University Hospitals Leuven
    Full Title: Fontan patients: Comprehensive evaluation of the pulmonary circulation to identify pulmonary vascular disease and its influence on ventricular hemodynamics.
    Medical condition: Fontan patients
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10010495 Congenital heart disease NOS LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001247-39 Sponsor Protocol Number: CV185-362 Start Date*: 2017-04-24
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban versus Vitamin K Antagonist or LMWH in Pediatric Subjects with Congenital or Acquired Heart ...
    Medical condition: Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10019273 Heart disease congenital PT
    20.0 10007541 - Cardiac disorders 10007636 Cardiomyopathy PT
    20.0 10007541 - Cardiac disorders 10019276 Heart disease, unspecified LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    20.0 10047065 - Vascular disorders 10023320 Kawasaki's disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) IT (Completed) FI (Completed) AT (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-000137-31 Sponsor Protocol Number: 2017-2019 Start Date*: 2017-12-19
    Sponsor Name:VU University Medical Center
    Full Title: Pulmonary Hypertension REversal in Clusters of Patients With Identical Pathobiological Substrates. 6-Mercaptopurine Proof-of-Concept Trial
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10037454 Pulmonary vascular disorders HLGT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10037401 Pulmonary hypertensions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-014246-29 Sponsor Protocol Number: BPS-MR-PAH-203 Start Date*: 2010-02-01
    Sponsor Name:Lung Rx
    Full Title: A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    12.0 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) BE (Prematurely Ended) DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2010-019883-36 Sponsor Protocol Number: CAMN107X2201 Start Date*: 2010-08-31
    Sponsor Name:Novartis Pharma AG
    Full Title: A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH)
    Medical condition: Pulmonary Arterial Hypertension (PAH) Class II or III patients remaining symptomatic despite at least one PAH-specific therapy.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) IT (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-002131-34 Sponsor Protocol Number: GS-US-357-1394 Start Date*: 2015-05-07
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension
    Medical condition: Men and women, ages 18 through 75 years, with a diagnosis of idiopathic PAH, heritable PAH or PAH associated with connective tissue disease (PAH-CTD), congenital heart defects (repaired), drug and ...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) NL (Completed) ES (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003438-28 Sponsor Protocol Number: AC-065A308 Start Date*: 2016-03-04
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-cont...
    Medical condition: Pulmonary arterial hypertension (PAH)
    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 (Completed) NO (Completed) FR (Completed) DK (Completed) AT (Completed) GB (Completed) ES (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2021-006787-25 Sponsor Protocol Number: 16122021 Start Date*: 2022-07-06
    Sponsor Name:Rigshospitalet The Heart Center
    Full Title: Effects of DAPAgliflozin on cardiopulmonary exercise capacity and hemodynamics in Pulmonary Arterial Hypertension: A double blind randomized trial
    Medical condition: Pulmonary arterial hypertension Chronic thromboembolic pulmonary hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10065150 Associated with pulmonary arterial hypertension LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10065151 Idiopathic pulmonary arterial hypertension LLT
    24.1 10010331 - Congenital, familial and genetic disorders 10085244 Heritable pulmonary arterial hypertension PT
    21.0 10038738 - Respiratory, thoracic and mediastinal disorders 10068740 CTEPH LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-000212-41 Sponsor Protocol Number: 206246 Start Date*: 2017-08-10
    Sponsor Name:GlaxoSmithKline, S.A.
    Full Title: An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension.
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077739 Pulmonary arterial hypertension WHO functional class I LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077729 Pulmonary arterial hypertension WHO functional class III LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077740 Pulmonary arterial hypertension WHO functional class II LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-000667-40 Sponsor Protocol Number: APD811-003 Start Date*: 2015-04-23
    Sponsor Name:Arena Pharmaceuticals, Inc.
    Full Title: A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    18.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) ES (Completed) PL (Completed) RO (Ongoing) SK (Completed)
    Trial results: View results
    EudraCT Number: 2014-004066-20 Sponsor Protocol Number: AC-055-403 Start Date*: 2015-05-14
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnet...
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-002788-80 Sponsor Protocol Number: Uni-Koeln-4243 Start Date*: 2020-09-09
    Sponsor Name:University of Cologne
    Full Title: An explorative study to assess the safety, tolerability, and efficacy of AZD4831 in the treatment of pulmonary arterial hypertension (PAH) (MPO-PAH)
    Medical condition: Group 1: Pulmonary arterial hypertension (PAH) Group 2: Postcapillary pulmonary hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    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: 2020-005896-12 Sponsor Protocol Number: CBYL719F12401 Start Date*: 2021-10-20
    Sponsor Name:Novartis Pharma AG
    Full Title: EPIK-P3: A phase II study to evaluate the long-term safety and efficacy of alpelisib in patients with PIK3CA-Related Overgrowth Spectrum (PROS) who previously participated in Study CBYL719F12002 (E...
    Medical condition: PIK3CA-related overgrowth spectrum (PROS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10010331 - Congenital, familial and genetic disorders 10081236 PIK3CA related overgrowth spectrum PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) IE (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-000421-13 Sponsor Protocol Number: 1913 Start Date*: 2017-07-27
    Sponsor Name:Erasmus MC
    Full Title: Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial
    Medical condition: Congenital diaphragmatic hernia with pulmonary hypertension
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) NO (Prematurely Ended) AT (Prematurely Ended) SE (Ongoing) BE (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-004689-32 Sponsor Protocol Number: SHP675-301 Start Date*: 2021-09-24
    Sponsor Name:Shire Human Genetic Therapies, Inc.
    Full Title: A Phase 3, Open-label Study to Evaluate the Efficacy and Safety of REPLAGAL® in Treatment-naïve Subjects with Fabry Disease
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    24.1 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Prematurely Ended) FI (Prematurely Ended) GR (Prematurely Ended) PL (Prematurely Ended)
    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) FR (Completed) BE (Completed) CZ (Prematurely Ended) PL (Prematurely Ended) IT (Prematurely Ended) BG (Prematurely Ended) ES (Ongoing) AT (Prematurely Ended)
    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
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