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Clinical trials for Benfluorex

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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    • 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   44364   clinical trials with a EudraCT protocol, of which   7388   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 ).  
     
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    2 result(s) found for: Benfluorex. Displaying page 1 of 1.
    EudraCT Number: 2005-004798-60 Sponsor Protocol Number: CL3-00780-148 Start Date*: Information not available in EudraCT
    Sponsor Name:I.R.I.S. Institut de Recherches Internationales Servier
    Full Title: A one-year multicentre, international, randomised, double-blind study with comparison of benfluorex (150 mg od to 150 mg tid) versus pioglitazone (30 mg od to 45 mg od) in combination with sulfonyl...
    Medical condition: Type II Diabetes
    Disease: Version SOC Term Classification Code Term Level
    7.0 10012613 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2011-001283-22 Sponsor Protocol Number: CL3-00780-150 Start Date*: 2011-07-13
    Sponsor Name:Institut de Recherches Internationales Servier (I.R.I.S.)
    Full Title: International follow-up study, after the investigational drug exposure in diabetic patients previously included in the REGULATE trial (benfluorex versus pioglitazone).
    Medical condition: Type II diabetes The medical condition investigated in the REGULATE trial (CL3-00780-148) was type II diabetes. The applied CL3-00780-150 trial, REGULATE follow-up study, is thus performed in d...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (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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