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Clinical trials for Connective Tissue Diseases AND Bosentan (Tracleer) AND 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
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    7 result(s) found for: Connective Tissue Diseases AND Bosentan (Tracleer) AND bosentan. Displaying page 1 of 1.
    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: 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: 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: 2011-001736-30 Sponsor Protocol Number: Start Date*: 2011-11-30
    Sponsor Name:Med. Univ. Wien, Klinik für Dermatologie
    Full Title: BOSENTAN FOR THE TREATMENT OF SKIN ULCERS IN DIABETIC MICROANGIOPATHY
    Medical condition: Bosentan for the treatment of skin ulcera in diabetic Microangiopathy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-002796-28 Sponsor Protocol Number: CEASESTIFFNESS Start Date*: 2016-04-12
    Sponsor Name:University Medical Center Groningen (UMCG)
    Full Title: The Clinical Efficacy And Subclinical Effects on arterial STIFFNESS of bosentan therapy added to usual care in patients with systemic sclerosis with digital ulcers.
    Medical condition: Systemic sclerosis (SSc) is characterized by skin fibrosis and visceral disease, mainly of the lungs, kidneys and the heart, accompanied by microvascular damage ultimately leading to digital ischem...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    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: 2009-017155-10 Sponsor Protocol Number: 10-aifa-2005-01 Start Date*: 2006-11-07
    Sponsor Name:CASA DI CURA PRIVATA S.RAFFAELE - PISANA
    Full Title: Evaluation of tolerability and efficacy of the combination Sildenafil/Bosentan in patients with severe pulmonary hypertension.
    Medical condition: severe pulmonary hypertension
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10037401 Pulmonary hypertensions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
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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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