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Clinical trials for PAH WHO Group I AND Hypertension

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   44344   clinical trials with a EudraCT protocol, of which   7373   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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    47 result(s) found for: PAH WHO Group I AND Hypertension. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2021-000199-12 Sponsor Protocol Number: A011-13 Start Date*: 2022-07-19
    Sponsor Name:Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and Hig...
    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: BE (Trial now transitioned) SE (Prematurely Ended) DE (Trial now transitioned) FR (Trial now transitioned) DK (Trial now transitioned) ES (Ongoing) AT (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned) CZ (Trial now transitioned) PL (Trial now transitioned) PT (Trial now transitioned) HR (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2009-012057-38 Sponsor Protocol Number: CQTI571A2301 Start Date*: 2009-08-13
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arteria...
    Medical condition: Pulmonary arterial hypertension (PAH) patients who have a PVR ≥800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) ES (Completed) FR (Completed) SE (Completed) BE (Completed) IT (Completed) NL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-002817-21 Sponsor Protocol Number: AC-065A310 Start Date*: Information not available in EudraCT
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as ...
    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: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) PL (Trial now transitioned) SE (Trial now transitioned) DE (Ongoing) ES (Ongoing) HU (Trial now transitioned) BE (Trial now transitioned) BG (Trial now transitioned) PT (Trial now transitioned) LT (Trial now transitioned) FI (Trial now transitioned) IT (Trial now transitioned) IE (Trial now transitioned)
    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: 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: 2004-000478-30 Sponsor Protocol Number: AC-052-364 Start Date*: 2004-10-28
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in pat...
    Medical condition: Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. T...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) AT (Completed) ES (Completed) CZ (Completed) GB (Completed) BE (Completed) DK (Completed) IT (Completed)
    Trial results: View results
    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) FR (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-021344-17 Sponsor Protocol Number: CQTI571A2102 Start Date*: 2011-01-28
    Sponsor Name:NOVARTIS FARMA
    Full Title: A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-admini...
    Medical condition: Pulmonary arterial hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064911 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-002440-14 Sponsor Protocol Number: AC-055-302 Start Date*: 2008-05-15
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomati...
    Medical condition: To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) DE (Completed) NL (Completed) FR (Completed) FI (Completed) SE (Completed) AT (Completed) DK (Completed) SK (Completed) PT (Prematurely Ended) IT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2008-003482-68 Sponsor Protocol Number: BAY 63-2521/12934 Start Date*: 2008-11-26
    Sponsor Name:Bayer HealthCare AG
    Full Title: Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptom...
    Medical condition: Pulmonary Arterial Hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IE (Prematurely Ended) AT (Completed) ES (Completed) NL (Completed) FR (Completed) SE (Completed) GB (Completed) CZ (Completed) DK (Completed) BE (Completed) IT (Completed) PT (Completed) GR (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: 2018-003093-27 Sponsor Protocol Number: GB002-1101 Start Date*: 2019-08-16
    Sponsor Name:GB002, Inc.
    Full Title: A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB00...
    Medical condition: Pulmonary Arterial Hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10077739 Pulmonary arterial hypertension WHO functional class I LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2018-001187-33 Sponsor Protocol Number: APD811-301 Start Date*: 2019-02-12
    Sponsor Name:Arena Pharmaceuticals, Inc.
    Full Title: A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients
    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: FR (Trial now transitioned) DE (Trial now transitioned) SE (Prematurely Ended) GB (GB - no longer in EU/EEA) HU (Trial now transitioned) DK (Trial now transitioned) PL (Trial now transitioned) CZ (Trial now transitioned) BE (Trial now transitioned) BG (Trial now transitioned) NL (Trial now transitioned) GR (Trial now transitioned) PT (Trial now transitioned) IT (Trial now transitioned) HR (Completed) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-004793-17 Sponsor Protocol Number: 402-C-1302 Start Date*: 2017-05-03
    Sponsor Name:Reata Pharmaceuticals, Inc.
    Full Title: A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Pulmonary Hypertension
    Medical condition: Pulmonary Hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10037401 Pulmonary hypertensions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Prematurely Ended) ES (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: 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
    EudraCT Number: 2017-004738-27 Sponsor Protocol Number: A011-09 Start Date*: 2018-08-15
    Sponsor Name:Acceleron Pharma Inc.
    Full Title: A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonar...
    Medical condition: Pulmonary Arterial Hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10077739 Pulmonary arterial hypertension WHO functional class I LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-011150-17 Sponsor Protocol Number: AMB112565 Start Date*: 2010-08-26
    Sponsor Name:GlaxoSmithKline R&D Ltd
    Full Title: AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension
    Medical condition: Pulmonary arterial hypotension
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) ES (Completed) BE (Completed) SE (Completed) GB (Completed) AT (Completed) GR (Completed) DE (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-001387-39 Sponsor Protocol Number: 1.4 Start Date*: 2019-03-15
    Sponsor Name:Thoraxklinik-Heidelberg gGmbH
    Full Title: A prospective, randomized, controlled trial to assess the effect of long-term oxygen therapy on 6-minute walking distance, clinical parameters and hemodynamics in patients with pulmonary arterial h...
    Medical condition: pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-001498-21 Sponsor Protocol Number: A011-14 Start Date*: 2021-11-11
    Sponsor Name:Acceleron Pharma Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) W...
    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: ES (Ongoing) IT (Trial now transitioned) NL (Trial now transitioned) BE (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned)
    Trial results: View results
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