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Clinical trials for 2011-005452-34

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44365   clinical trials with a EudraCT protocol, of which   7389   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: 2011-005452-34. Displaying page 1 of 1.
    EudraCT Number: 2011-005452-34 Sponsor Protocol Number: SPD489-406 Start Date*: 2013-08-20
    Sponsor Name:Shire Development LLC
    Full Title: A Phase 4, Randomised, Double-blind, Multicenter, Parallel-group, Active-controlled, Forced-dose Titration, Safety and Efficacy Study of SPD489 Compared with OROS-MPH with a Placebo Referance Arm, ...
    Medical condition: Attention-deficit/hyperactivity disorder is a psychiatric disorder characterized by developmentally inappropriate degrees of inattentiveness, impulsivity, and hyperactivity
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004873 10064104 ADHD LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) IT (Prematurely Ended) HU (Completed) SE (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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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