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Clinical trials for 2011-001255-36

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    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).

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    1 result(s) found for: 2011-001255-36. Displaying page 1 of 1.
    EudraCT Number: 2011-001255-36 Sponsor Protocol Number: GS-US-205-0162 Start Date*: 2012-01-16
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients with Cyst...
    Medical condition: Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10070608 Infective pulmonary exacerbation of cystic fibrosis PT
    14.1 10021881 - Infections and infestations 10068288 Cystic fibrosis pulmonary exacerbation LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) FR (Ongoing) AT (Completed) ES (Completed) NL (Completed) IE (Completed) IT (Completed) Outside EU/EEA
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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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