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Clinical trials for Applicability domain

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    2 result(s) found for: Applicability domain. Displaying page 1 of 1.
    EudraCT Number: 2021-003791-13 Sponsor Protocol Number: BP42992 Start Date*: 2022-01-11
    Sponsor Name:F. HOFFMANN - LA ROCHE LTD.
    Full Title: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, EFFICACY, AND PHARMACODYNAMICS OF 52 WEEKS OF TREATMENT WITH BASMISANIL IN CHILDREN WITH DUP15...
    Medical condition: Dup15q Syndrome
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004850 10083952 Dup15q syndrome LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) ES (Prematurely Ended) PT (Prematurely Ended) PL (Completed) NL (Ongoing)
    Trial results: View results
    EudraCT Number: 2012-000547-27 Sponsor Protocol Number: CTIMPMCRENAL12 Start Date*: 2012-11-01
    Sponsor Name:East and North Hertfordshire NHS Trust [...]
    1. East and North Hertfordshire NHS Trust
    2. University of Hertfordshire
    Full Title: A Pilot Randomised Controlled Trial of Drug Treatment for Depression in Patients undergoing Haemodialysis
    Medical condition: Major Depressive Disorder in Patients with End Stage Renal Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10025453 Major depressive disorder NOS LLT
    14.1 10042613 - Surgical and medical procedures 10066623 Chronic haemodialysis LLT
    14.1 10038359 - Renal and urinary disorders 10014647 End stage renal failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
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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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