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Clinical trials for Macitentan

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   44343   clinical trials with a EudraCT protocol, of which   7372   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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    33 result(s) found for: Macitentan. Displaying page 1 of 2.
    1  2  Next»
    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: 2016-001062-28 Sponsor Protocol Number: AC-055-312 Start Date*: 2017-01-25
    Sponsor Name:ACTELION Pharmaceuticals Ltd
    Full Title: A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children 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
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) AT (Completed) PT (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) FR (Completed) FI (Completed) Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2019-004131-24 Sponsor Protocol Number: 67896062CTP3001 Start Date*: 2020-05-29
    Sponsor Name:ACTELION Pharmaceuticals Ltd.
    Full Title: A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in ino...
    Medical condition: 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
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) DE (Completed) GB (GB - no longer in EU/EEA) HU (Completed) PL (Completed) ES (Prematurely Ended) AT (Completed) SK (Completed) LT (Completed) FR (Completed) IT (Prematurely Ended) PT (Prematurely Ended) DK (Completed)
    Trial results: View results
    EudraCT Number: 2017-003934-10 Sponsor Protocol Number: AC-055-314 Start Date*: 2018-03-19
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary arterial hypertension previousLy treated with mAcitentan in clinical studies
    Medical condition: Pulmonary arterial hypertension (PAH)
    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: FR (Completed) PL (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-002950-56 Sponsor Protocol Number: AC-055E201 Start Date*: 2014-02-20
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chron...
    Medical condition: Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004855 10068739 Chronic thromboembolic pulmonary hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) AT (Completed) BE (Completed) GB (Completed) HU (Completed) NL (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2010-022710-77 Sponsor Protocol Number: AC-055C301 Start Date*: 2011-06-16
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers a...
    Medical condition: Ischemic digital ulcers associated with systemic sclerosis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10028395 - Musculoskeletal and connective tissue disorders 10042953 Systemic sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) CZ (Completed) DK (Prematurely Ended) BG (Completed) FI (Completed) IT (Completed) PL (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 (Trial now transitioned) HU (Trial now transitioned) SE (Trial now transitioned) FR (Trial now transitioned) GB (GB - no longer in EU/EEA) DK (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned) PT (Trial now transitioned) BE (Trial now transitioned) NO (Completed) SK (Trial now transitioned) AT (Trial now transitioned) IT (Trial now transitioned) BG (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: 2023-000984-30 Sponsor Protocol Number: 67896062PAH3001 Start Date*: 2024-01-03
    Sponsor Name:Janssen Pharmaceutical K.K.
    Full Title: A Multicenter, Open-label, Phase III Study to Assess the Efficacy, Safety, and Pharmacokinetics of Macitentan in Japanese Pediatric Patients (≥3 months to <15 years) with Pulmonary Arterial Hyperte...
    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, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2018-002623-42 Sponsor Protocol Number: 66623 Start Date*: 2019-02-18
    Sponsor Name:Academic Medical Center
    Full Title: Vasospastic angina treatment by Endothelin Receptor Antagonism; a proof of concept study
    Medical condition: Vasospastic angina, i.e. epicardial vasospasm or microvascular coronary dysfunction.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10002383 Angina pectoris PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022969-95 Sponsor Protocol Number: AC-055C302 Start Date*: 2011-12-21
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers a...
    Medical condition: Ischemic digital ulcers associated with systemic sclerosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10042953 Systemic sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) IE (Prematurely Ended) ES (Prematurely Ended) BE (Prematurely Ended) NL (Completed) PT (Prematurely Ended) PL (Prematurely Ended) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003457-25 Sponsor Protocol Number: AC-055E202 Start Date*: 2014-06-13
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic...
    Medical condition: Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10068739 Chronic thromboembolic pulmonary hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) GB (GB - no longer in EU/EEA) HU (Completed) DE (Completed) AT (Completed) NL (Completed) LT (Completed) FR (Completed)
    Trial results: View results
    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: 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: 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: 2016-003653-15 Sponsor Protocol Number: AC-055G202 Start Date*: 2017-09-12
    Sponsor Name:ACTELION Pharmaceuticals Ltd
    Full Title: A multi-center, double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascu...
    Medical condition: Heart failure with preserved ejection fraction and pulmonary vascular disease
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004849 10076396 Heart failure with preserved ejection fraction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) GB (GB - no longer in EU/EEA) DK (Completed) CZ (Completed) AT (Completed) SE (Completed) ES (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2014-004624-21 Sponsor Protocol Number: AC-055-404 Start Date*: 2015-04-13
    Sponsor Name:ACTELION Pharmaceuticals Ltd.
    Full Title: A randomized, double-blind, placebo-controlled, prospective, multicenter, parallel group study to assess the safety and efficacy of macitentan in patients with portopulmonary hypertension
    Medical condition: Portopulmonary hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10067281 Portopulmonary hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) CZ (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-001603-37 Sponsor Protocol Number: AC-055G203 Start Date*: 2019-07-16
    Sponsor Name:ACTELION Pharmaceuticals Ltd
    Full Title: A long-term, multicenter, single-arm, open-label extension of the SERENADE study, to assess the safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction and...
    Medical condition: Heart failure with preserved ejection fraction and pulmonary vascular disease
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004849 10076396 Heart failure with preserved ejection fraction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended) DE (Prematurely Ended) HU (Prematurely Ended) DK (Prematurely Ended) SE (Prematurely Ended) RO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-006054-17 Sponsor Protocol Number: AC-055B201 Start Date*: Information not available in EudraCT
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis
    Medical condition: To evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021240 Idiopathic pulmonary fibrosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) ES (Completed) SI (Completed) SE (Completed) IT (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
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