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Clinical trials for 2021-001441-12

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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    The EU Clinical Trials Register currently displays   44336   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: 2021-001441-12. Displaying page 1 of 1.
    EudraCT Number: 2021-001441-12 Sponsor Protocol Number: OP0595-5 Start Date*: 2023-03-10
    Sponsor Name:Meiji Seika Pharma Co., Ltd.
    Full Title: A Phase 3, Multi-Center, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in the Treatment of Compli...
    Medical condition: Complicated urinary tract infection (cUTI) and acute uncomplicated pyelonephritis (AP)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10021881 - Infections and infestations 10080628 Complicated urinary tract infection LLT
    20.1 10021881 - Infections and infestations 10001032 Acute pyelonephritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Trial now transitioned) BG (Trial now transitioned) SK (Trial now transitioned) CZ (Trial now transitioned) LV (Trial now transitioned)
    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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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