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Clinical trials for Bosentan

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 ).  
     
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    74 result(s) found for: Bosentan. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2007-000221-22 Sponsor Protocol Number: BANDY 070112 Start Date*: 2007-10-15
    Sponsor Name:John Pernow
    Full Title: Effect of bosentan on macro- and microvascular function in patients with type 2 diabetes
    Medical condition: Type 2 diabetes and albuminuria.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-023366-49 Sponsor Protocol Number: Bosentan for HPS Start Date*: 2011-07-22
    Sponsor Name:Med. Univ. Wien, Univ. Klinikum für Interne Medizin III
    Full Title: Bosentan for treatment ofhepatopulmonary syndrome in patients with liver cirrhosis - a prospective double blind randomized controlled clinical study
    Medical condition: HPS is by far the most frequent respiratory complication of cirrhosis leading to significantly increased mortality. The only therapeutic option is liver transplantation. Many patients with HPS who ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-004288-23 Sponsor Protocol Number: Start Date*: 2008-04-28
    Sponsor Name:Medizinische Universität Graz
    Full Title: Frühtherapie der pulmonal arteriellen Hypertonie (PAH)
    Medical condition: Exercise induced pulmonary hypertension in patients with connective tissue disaeses
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-005303-32 Sponsor Protocol Number: AC-052-438 Start Date*: 2012-03-05
    Sponsor Name:Actelion Pharmaceuticals Nederland bv
    Full Title: Effects of bosentan in a HOMogenEous population of SSc subjects with an early or active SSc nailfold capillaroscopic pattern (HOME II)
    Medical condition: Digital Ulcera in Systemic Sclerodermia patients
    Disease: Version SOC Term Classification Code Term Level
    14.1 10022891 - Investigations 10053400 Endothelin increased PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2006-003133-33 Sponsor Protocol Number: EMG-2006 Start Date*: 2006-07-14
    Sponsor Name:Hôpital Erasme
    Full Title: Etude des effets d’un antagoniste non spécifique de l’endothéline (le bosentan) sur l’activité orthosympathique et le chémoréflexe.
    Medical condition: healthy subjects obstructive sleep apnea (Bosentan is used in clinic in pulmonary hypertension)
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023908-27 Sponsor Protocol Number: AC-052-427 Start Date*: 2011-03-16
    Sponsor Name:Actelion Pharmaceuticals Nederland bv
    Full Title: Effects of bosentan in a HOMogenEous population of SSc subjects with a predefined restriction of blood flow in the hands (HOME)
    Medical condition: Digital Ulcera in Systemic Sclerodermia patients
    Disease: Version SOC Term Classification Code Term Level
    12.1 10053400 Endothelin increased LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2006-001464-23 Sponsor Protocol Number: A1481243 Start Date*: 2006-06-08
    Sponsor Name:Pfizer Ltd,Ramsgate Road,Sandwich CT13 9NJ
    Full Title: A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 ...
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) GB (Completed) IT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2010-023822-19 Sponsor Protocol Number: bosentan2010 Start Date*: 2011-04-06
    Sponsor Name:Juan Pedro Barret Nerín
    Full Title: ESTUDIO DE LA EFICACIA DE BOSENTAN EN LA MODULACIÓN DE LA RESPUESTA INFLAMATORIA Y DE LA CICATRIZACIÓN EN PACIENTES QUEMADOS
    Medical condition: Quemaduras profundas quirúrgicas
    Disease: Version SOC Term Classification Code Term Level
    13 10043418 Quemaduras térmicas HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-021793-12 Sponsor Protocol Number: AC-052-374 Start Date*: 2011-04-04
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with p...
    Medical condition: Pulmonary arterial hypertension (PAH) in children
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004855 10064910 Familial (FPAH) LLT
    16.1 100000004855 10064909 Idiopathic (IPAH) LLT
    16.1 100000004855 10064908 Associated with (APAH) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) CZ (Completed) FR (Ongoing) NL (Completed) ES (Completed) IT (Completed) PL (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-001967-70 Sponsor Protocol Number: AC-052-367 Start Date*: 2005-10-13
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertensi...
    Medical condition: Idiopathic or familial pulmonary arterial hypertension
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-005157-63 Sponsor Protocol Number: AC-052-365 Start Date*: 2005-06-15
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: An open label, multicenter study to assess the pharmacokinetics, tolerability, and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertens...
    Medical condition: Idiopathic or familial PAH
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-005066-37 Sponsor Protocol Number: AC-052-415 Start Date*: 2006-03-15
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospe...
    Medical condition: Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital s...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) IT (Completed) 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: 2004-000745-37 Sponsor Protocol Number: AC-052-413 Start Date*: 2004-10-11
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUS...
    Medical condition: Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-002686-21 Sponsor Protocol Number: Bosentan1 Start Date*: 2005-02-22
    Sponsor Name:Dept of Dermatology
    Full Title: Efficacy of Endothelin 1 receptor antagonist Bosentan in secondary Raynauds Syndrom
    Medical condition: secondary Raynauds Syndrome
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2005-001965-33 Sponsor Protocol Number: AC-052-366 Start Date*: 2005-11-01
    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 bosentan in patients with inoperable chronic thromboe...
    Medical condition: Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10037436 Pulmonary thromboembolism LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) ES (Completed) AT (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-004533-21 Sponsor Protocol Number: 03602 Start Date*: 2010-06-25
    Sponsor Name:ICIN
    Full Title: The role of Bosentan in fontan patients: improvement of aerobic capacity
    Medical condition: To study whether bosentan (endothelin receptor inhibitor) improves aerobic capacity (VO2max) and exercise performance in adult patients with a Fontan operation.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-005333-11 Sponsor Protocol Number: 0722 Start Date*: 2007-12-28
    Sponsor Name:University Hospital of Grenoble
    Full Title: Comparaison des effets du bosentan et de la pression positive continue sur les complications cardiovasculaires du syndrome d’apnées du sommeil
    Medical condition: Syndrome d'apnées du sommeil et hypertension artérielle
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-021825-11 Sponsor Protocol Number: AC-052-373 Start Date*: 2011-04-28
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with...
    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, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) HU (Completed) DE (Completed) ES (Completed) CZ (Completed) FR (Ongoing) IT (Completed) BG (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-001183-24 Sponsor Protocol Number: AC-052-321 Start Date*: 2007-03-06
    Sponsor Name:ACTELION PHARMACEUTICALS LTD
    Full Title: Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequ...
    Medical condition: Idiopathic Pulmonary Fibrosis (IPF)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10021240 Idiopathic pulmonary fibrosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed) IE (Completed) GB (Completed) FR (Completed) DE (Completed) AT (Completed) DK (Completed) CZ (Completed) IT (Completed) SK (Completed) ES (Completed)
    Trial results: View results
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    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.

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