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Clinical trials for Mipomersen

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 ).  
     
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    8 result(s) found for: Mipomersen. Displaying page 1 of 1.
    EudraCT Number: 2011-001480-42 Sponsor Protocol Number: MIPO3801011 Start Date*: 2012-04-26
    Sponsor Name:Genzyme Corporation and its Affiliates
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients with Familial Hypercholesterolemi...
    Medical condition: Heterozygous familial hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10057079 Heterozygous familial hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) SE (Completed) BE (Completed) GB (Completed) FR (Completed) HU (Completed) DE (Completed) CZ (Completed) GR (Completed) IT (Completed) PL (Completed) SK (Completed) NL (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2011-002539-24 Sponsor Protocol Number: MICA Start Date*: 2012-05-03
    Sponsor Name:Hospital of the University of Munich
    Full Title: Effect of Mipomersen on LDL-Cholesterol Levels in Patients with Severe LDL-Hypercholesterolemia and Atherosclerosis Treated by Regular LDL-Apheresis
    Medical condition: In this trial, the effect of mipomersen is tested on LDL-cholesterol levels in patients with severe LDL-hypercholesterolemia and atherosclerosis which are regularly treated by LDL-apheresis.
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10027424 Metabolic and nutritional disorders congenital HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-003450-10 Sponsor Protocol Number: ISIS 301012-CS6 Start Date*: 2008-10-02
    Sponsor Name:Genzyme Europe B.V.
    Full Title: An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 301012 in Patients with Familial Hypercholesterolemia or Severe Hypercholesterolemia
    Medical condition: Patients with homozygous and heterozygous familial hypercholesterolemia or severe hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020604 Hypercholesterolemia LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-006020-53 Sponsor Protocol Number: MIPO3500108 Start Date*: 2009-04-08
    Sponsor Name:Genzyme Europe B.V.
    Full Title: A Prospective Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering...
    Medical condition: Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who are Not on Apheresis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020603 Hypercholesterolaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-004390-44 Sponsor Protocol Number: LIB003-004 Start Date*: 2021-09-08
    Sponsor Name:LIB Therapeutics, LLC
    Full Title: Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Heterozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering T...
    Medical condition: Heterozygous Familial Hypercholesterolemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004392-40 Sponsor Protocol Number: LIB003-005 Start Date*: 2021-12-21
    Sponsor Name:LIB Therapeutics, LLC
    Full Title: Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Cardiovascular Disease on Stable Lipid-Lowering Therapy Requirin...
    Medical condition: Patients With Cardiovascular Disease on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004849 10007648 Cardiovascular disease, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NO (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004393-22 Sponsor Protocol Number: LIB003-006 Start Date*: 2022-01-13
    Sponsor Name:LIB Therapeutics, LLC
    Full Title: Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Cardiovascular Disease, or at High Risk for Cardiovascular Disea...
    Medical condition: Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease, on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004849 10007648 Cardiovascular disease, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NO (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-002871-20 Sponsor Protocol Number: LIB003-012 Start Date*: 2022-04-21
    Sponsor Name:LIB Therapeutics, LLC
    Full Title: Randomized, Open Label, Phase 3 Study to Evaluate the Efficacy and Safety of Lerodalcibep (LIB003) compared to Inclisiran in Patients With Cardiovascular Disease, or at High Risk for Cardiovascula...
    Medical condition: Patients with atherosclerotic cardiovascular (CV) disease (ASCVD) or high risk of ASCVD who need additional LDL-C reduction
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004849 10007648 Cardiovascular disease, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) NO (Completed) ES (Ongoing)
    Trial results: (No results available)
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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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