Flag of the European Union EU Clinical Trials Register Help

Clinical trials for extended-release guanfacine (Intuniv)

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   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).

    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.
    How to search [pdf]
    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.
    Advanced Search: Search tools
     
    5 result(s) found for: extended-release guanfacine (Intuniv). Displaying page 1 of 1.
    EudraCT Number: 2011-004668-31 Sponsor Protocol Number: SPD503-318 Start Date*: 2012-03-14
    Sponsor Name:Shire Pharmaceutical Development Ltd
    Full Title: A Phase 3, Open-label, Multicentre, Protocol to Provide Access to Guanfacine Hydrochloride Extended Release for European Subjects with Attention-deficit/Hyperactivity Disorder (ADHD) who Participat...
    Medical condition: Attention Deficit/Hyperactivity Disorder (ADHD)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004873 10064104 ADHD LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) SE (Completed) AT (Completed) ES (Completed) IE (Completed) BE (Completed) IT (Completed) NL (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-018579-12 Sponsor Protocol Number: SPD503-316 Start Date*: 2011-01-26
    Sponsor Name:Shire Pharmaceutical Development Ltd
    Full Title: A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children...
    Medical condition: Attention-Deficit/Hyperactivity Disorder (ADHD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10068451 ADHD, combined type LLT
    14.1 10037175 - Psychiatric disorders 10068453 ADHD, predominantly inattentive type LLT
    14.1 10037175 - Psychiatric disorders 10068452 ADHD, predominantly hyperactive-impulsive type LLT
    14.1 10037175 - Psychiatric disorders 10064104 ADHD LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) NL (Prematurely Ended) FR (Completed) ES (Completed) SE (Completed) IE (Completed) AT (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-018161-12 Sponsor Protocol Number: SPD503-315 Start Date*: 2010-12-23
    Sponsor Name:Shire Development Inc
    Full Title: A Phase 3, Double-blind, Placebo-controlled, Multicentre, Randomised withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adol...
    Medical condition: Attention-Deficit/Hyperactive Disorder (ADHD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004873 10068451 ADHD, combined type LLT
    14.1 100000004873 10068453 ADHD, predominantly inattentive type LLT
    14.1 100000004873 10068452 ADHD, predominantly hyperactive-impulsive type LLT
    14.1 100000004873 10064104 ADHD LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) NL (Completed) ES (Completed) SE (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002598-36 Sponsor Protocol Number: 16IC3372 Start Date*: 2017-03-03
    Sponsor Name:Imperial College London
    Full Title: Randomised Clinical Trial of Noradrenergic Add-on Therapy with Extended-Release Guanfacine in Alzheimer's Disease
    Medical condition: Alzheimer's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10001897 Alzheimer's disease (incl subtypes) HLT
    20.0 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    20.0 10029205 - Nervous system disorders 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2011-002221-21 Sponsor Protocol Number: SPD503-312 Start Date*: 2011-08-30
    Sponsor Name:Shire Development Inc
    Full Title: A Phase 3, Double-blind, Randomized, Multi-center, Placebo controlled, Dose-optimization Study Evaluating the Safety, Efficacy, and Tolerability of Once daily Dosing with Extended-release Guanfacin...
    Medical condition: Attention-Deficit/Hyperactivity Disorder (ADHD)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10037175 - Psychiatric disorders 10068451 ADHD, combined type LLT
    14.0 10037175 - Psychiatric disorders 10068453 ADHD, predominantly inattentive type LLT
    14.0 10037175 - Psychiatric disorders 10068452 ADHD, predominantly hyperactive-impulsive type LLT
    14.0 10037175 - Psychiatric disorders 10064104 ADHD LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    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.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 16 11:28:39 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA