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Clinical trials for 2005-005068-97

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    The EU Clinical Trials Register currently displays   44258   clinical trials with a EudraCT protocol, of which   7344   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).

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    1 result(s) found for: 2005-005068-97. Displaying page 1 of 1.
    EudraCT Number: 2005-005068-97 Sponsor Protocol Number: AC-052-414 Start Date*: Information not available in EudraCT
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - bli...
    Medical condition: Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA: a.Idiopathic (IPAH) b.Familial (FPAH) c.Associated w...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064908 Associated with (APAH) LLT
    9.1 10064909 Idiopathic (IPAH) LLT
    9.1 10064910 Familial (FPAH) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) DK (Completed) GB (Completed) ES (Completed) PT (Completed) GR (Completed) BE (Completed) CZ (Completed) SK (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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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