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Clinical trials for Eplerenone

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   44351   clinical trials with a EudraCT protocol, of which   7378   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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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
    Study title: CLINICAL PROTOCOL FOR THE POPULATION PHARMACOKINETICS OF EPLERENONE IN PEDIATRIC AND ADULT HYPERTENSIVE PATIENTS
    Active substance: EPLERENONE
    Study summary document link (including results): NE3-01-02-055 EMA Pediatrics Web Synopsis.pdf
    View full study record
    Document reference: 26401
    Study title: PEDS I PEDIATRIC EPLERENONE DEVELOPMENT STUDY I): A RANDOMIZED, DOUBLE-BLIND, PLACEBO WITHDRAWAL, PARALLEL GROUP, DOSE-RESPONSE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EPLERENONE IN THE TREATMENT OF HYPERTENSION IN CHILDREN
    Active substance: EPLERENONE
    Study summary document link (including results): A6141001 PhRMA Clinical Study Synopsis.pdf
    View full study record
    Document reference: 26399
    Study title: PEDS II (PEDIATRIC EPLERENONE DEVELOPMENT STUDY II)--AN OPEN LABEL, LONG-TERM STUDY TO EVALUATE THE SAFETY OF EPLERENONE IN THE TREATMENT OF HYPERTENSION IN CHILDREN
    Active substance: EPLERENONE
    Study summary document link (including results): A6141077 PhRMA Web Synopsis.pdf
    View full study record
    Document reference: 26400
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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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