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Clinical trials for Bile acid sequestrants

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 ).  
     
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    21 result(s) found for: Bile acid sequestrants. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2014-004856-68 Sponsor Protocol Number: CB8025-21427 Start Date*: 2015-04-29
    Sponsor Name:CymaBay Therapeutics, Inc.
    Full Title: A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH)
    Medical condition: Homozygous Familial Hypercholesterolemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) NL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2008-007058-36 Sponsor Protocol Number: 733-005 Start Date*: 2009-06-25
    Sponsor Name:Aegerion Pharmaceuticals
    Full Title: A Phase III Study of Microsomal Triglyceride Transfer Protein (MTP) Inhibitor AEGR-733 in Patients with Homozygous Familial Hypercholesterolemia on Current Lipid-lowering Therapy
    Medical condition: Homozygous Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10048373 Hypercholesterolaemia aggravated LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-000396-20 Sponsor Protocol Number: Dropizol_2020 Start Date*: 2021-01-02
    Sponsor Name:Mech-Sense, Aalborg University Hospital
    Full Title: Opium tincture against chronic diarrhea - Patients: An investigator initiated, randomized placebo-controlled, clinical trial
    Medical condition: Chronic diarrhea
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10066556 Chronic diarrhea LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    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: 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: 2011-004287-30 Sponsor Protocol Number: LAL-CL06 Start Date*: 2014-06-19
    Sponsor Name:Alexion Pharmaceuticals inc
    Full Title: A Multicenter, Open-Label Study of Sebelipase Alfa in Patients with Lysosomal Acid Lipase Deficiency
    Medical condition: Lysosomal Acid Lipase Deficiency (LALD)
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004850 10024579 Lysosomal storage disorders HLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DK (Completed) ES (Completed) GB (Completed) IT (Prematurely Ended) DE (Completed) BE (Completed) HR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2008-000465-37 Sponsor Protocol Number: 0524A-082 Start Date*: 2008-05-30
    Sponsor Name:Laboratoires Merck Sharp & Dohme - Chibret
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Ther...
    Medical condition: Dyslipidemia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020604 Hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) AT (Prematurely Ended) ES (Prematurely Ended) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-005400-15 Sponsor Protocol Number: 20110271 Start Date*: 2012-03-22
    Sponsor Name:Amgen Inc
    Full Title: A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial Hypercholesterolemia
    Medical condition: Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000012386 10057100 Homozygous familial hypercholesterolaemia LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GR (Completed) CZ (Completed) GB (Completed) ES (Completed) IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2016-003376-49 Sponsor Protocol Number: MDCO-PCS-16-02 Start Date*: 2017-06-20
    Sponsor Name:The Medicines Company
    Full Title: An Open-Label, Single-Arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of ALN-PCSSC in Subjects with Homozygous Familial Hypercholesterolemia
    Medical condition: Homozygous Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004850 10057080 Homozygous familial hypercholesterolemia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2005-003449-15 Sponsor Protocol Number: 301012-CS5 Start Date*: 2007-07-12
    Sponsor Name:Genzyme Europe B.V.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ISIS 301012 as Add-on Therapy in Homozygous Familial Hypercholesterolemia Subjects
    Medical condition: Reduction of low density lipoprotein C (LDL-C) in Homozygous Familial Hypercholesterolemia (HoFH)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10057080 Homozygous familial hypercholesterolemia LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-000641-13 Sponsor Protocol Number: BIO89-100-221 Start Date*: 2020-09-30
    Sponsor Name:89bio, Inc.
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of BIO89-100 in Subjects with Severe Hypertriglyceridemia
    Medical condition: Severe Hypertriglyceridemia (SHTG)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10020870 Hypertriglyceridemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-005399-40 Sponsor Protocol Number: 20110233 Start Date*: 2012-03-09
    Sponsor Name:Amgen Inc
    Full Title: A two part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Part A - Open-label, Single-arm, Multicenter Pilot...
    Medical condition: Homozygous familial hypercholesterolaemia
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10057100 Homozygous familial hypercholesterolaemia LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) ES (Completed) IT (Completed) NL (Completed) Outside EU/EEA
    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: 2019-003611-62 Sponsor Protocol Number: LIB003-003 Start Date*: 2020-03-20
    Sponsor Name:LIB Therapeutics, LLC
    Full Title: Randomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 with Evolocumab in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy.
    Medical condition: Homozygous Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10057080 Homozygous familial hypercholesterolemia LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001446-25 Sponsor Protocol Number: FHGT002 Start Date*: 2017-09-20
    Sponsor Name:University of Pennsylvania
    Full Title: AAV8-mediated Low Density Lipoprotein Receptor (LDLR) Gene Replacement in Subjects with Homozygous Familial Hypercholesterolemia (HoFH)
    Medical condition: Adults with homozygous familial hypercholesterolemia
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) IT (Prematurely Ended)
    Trial results: View results
    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: 2015-003511-37 Sponsor Protocol Number: K-877-301 Start Date*: 2017-01-16
    Sponsor Name:Kowa Research Institute, Inc.
    Full Title: A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double­Blind, 12-Week Study With a 40-Week, Active-Controlled, Double­Blind Extension to Evaluate the Efficacy and Safety of K-877 in Adult ...
    Medical condition: severe hypertriglyceridemia [fasting TG levels >=500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10020667 Hyperlipidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-004394-49 Sponsor Protocol Number: LIB003-007 Start Date*: 2021-08-12
    Sponsor Name:LIB Therapeutics, LLC
    Full Title: Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at ...
    Medical condition: Patients With Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10057079 Heterozygous familial hypercholesterolemia LLT
    20.0 100000004850 10057080 Homozygous familial hypercholesterolemia LLT
    20.1 100000004849 10007648 Cardiovascular disease, unspecified LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) 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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