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Clinical trials for Colesevelam

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   44359   clinical trials with a EudraCT protocol, of which   7383   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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    10 result(s) found for: Colesevelam. Displaying page 1 of 1.
    EudraCT Number: 2016-001452-22 Sponsor Protocol Number: SJ-641 Start Date*: 2018-08-29
    Sponsor Name:Zealand University Hospital
    Full Title: Treatment effect of colesevelam for bile acid diarrhoea
    Medical condition: Bile acid diarrhoea
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10069703 Bile acid malabsorption PT
    20.1 10017947 - Gastrointestinal disorders 10066557 Chronic diarrhoea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2005-003511-75 Sponsor Protocol Number: WEL-410 Start Date*: 2005-10-18
    Sponsor Name:Sankyo Pharma Development (SPhD)
    Full Title: Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Colesevelam HCl Administered to Pediatric Patients with Heterozygous Familial Hypercholesterolemia on a Stable Dose of Stat...
    Medical condition: Pediatric Heterozygous Familial Hypercholesterolemia (heFH)
    Disease: Version SOC Term Classification Code Term Level
    8.0 10057079 LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed) NO (Ongoing) HU (Completed) SK (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2021-000667-74 Sponsor Protocol Number: CV006 Start Date*: 2021-11-30
    Sponsor Name:Medisch Centrum Leeuwarden BV
    Full Title: The effect of bile acid binding with colesevelam on postprandial glucose concentrations in patients after RYGB and cholecystectomy : a meal test study
    Medical condition: Post Bariatric Hypoglycemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004861 10059038 Postprandial hypoglycemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-010727-91 Sponsor Protocol Number: 00695 Start Date*: 2011-03-01
    Sponsor Name:LMU München, Campus Großhadern
    Full Title: Colesevelam for the treatment of bile acid malabsorption in patients with Crohn’s disease (Colesevelam für die Therapie der Gallensäuren-Malabsorption bei M. Crohn-Patienten)
    Medical condition: Morbus Crohn
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-001559-38 Sponsor Protocol Number: GEICAM/2018-06 Start Date*: 2022-01-20
    Sponsor Name:GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)
    Full Title: A Randomized Phase II Study to Evaluate the Incidence of Discontinuations due to Diarrhoea at 3 Cycles in patients with Early-stage HER2-positive (HER2+), Hormone Receptor-positive (HR+) Breast Can...
    Medical condition: HER2+, HR+ Early stage Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER2 positive breast cancer PT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10083234 Hormone receptor positive breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-000582-37 Sponsor Protocol Number: CHOL00107 Start Date*: 2007-09-21
    Sponsor Name:Genzyme Europe BV
    Full Title: A Phase 4 Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Study of Colesevelam as Add-on Therapy in Patients with Familial Hypercholesterolaemia
    Medical condition: Familial hypercholesterolaemia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10049593 Familial hypercholesterolaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) FR (Completed) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-001638-33 Sponsor Protocol Number: IKEM-CEM-01 Start Date*: 2012-10-10
    Sponsor Name:Institute for Clinical and Experimental Medicine
    Full Title: Cholesterol 7alpha-hydroxylase polymorphism as a predictor cholesterolemia responsiveness
    Medical condition: hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10020604 Hypercholesterolemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-000533-31 Sponsor Protocol Number: 17GA001 Start Date*: 2017-11-07
    Sponsor Name:Nottingham University Hospitals NHS Trust
    Full Title: TReatment of Irritable bowel syndrome using Titrated ONdansetron Trial
    Medical condition: Irritable Bowel Syndrome with Diarrhoea
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10060845 Diarrhea predominant irritable bowel syndrome LLT
    21.1 100000004856 10060849 Diarrhoea predominant irritable bowel syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003708-62 Sponsor Protocol Number: BIAsp-4157 Start Date*: 2015-06-03
    Sponsor Name:Novo Nordisk A/S
    Full Title: A 32-week randomised, multinational, treat-to-target, open label, parallel group comparison of stepwise insulin intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with in...
    Medical condition: Diabetes Mellitus, Type 2
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) HU (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
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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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