- Trials with a EudraCT protocol (49)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (4)
49 result(s) found for: Pulmonary Shunt.
Displaying page 1 of 3.
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. | |||||||||||||
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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. | |||||||||||||
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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 | |||||||||||||
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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) | |||||||||||||||||||||||
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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 | |||||||||||||
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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) | |||||||||||||
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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 | |||||||||||||
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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 | |||||||||||||
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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) | |||||||||||||
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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 | |||||||||||||
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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 | ||||||||||||||||||
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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 | |||||||||||||
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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 | |||||||||||||
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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 | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: NL (Ongoing) | |||||||||||||
Trial results: (No results available) |
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