Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Heterozygote

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   43881   clinical trials with a EudraCT protocol, of which   7295   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
     
    42 result(s) found for: Heterozygote. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2006-001913-13 Sponsor Protocol Number: 0524A-041 Start Date*: 2006-11-29
    Sponsor Name:Merck & Co., Inc.
    Full Title: A Worldwide, Double-Blind, Randomized, Placebo-Controlled Study of MK-0524A 2g Coadministered with Intensive LDL-C Lowering Therapy Compared to Intensive LDL-C Lowering Therapy Alone on Carotid Art...
    Medical condition: heterozygous familial hypercholesterolemia (HeFH)
    Disease: Version SOC Term Classification Code Term Level
    9.0 10057099 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) FR (Prematurely Ended) SE (Prematurely Ended) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-002911-80 Sponsor Protocol Number: LOCHNES Start Date*: 2018-12-18
    Sponsor Name:AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO "PAOLO GIACCONE" DI PALERMO
    Full Title: Open-label study to evaluate the safety, tolerability, and efficacy of LOmitapide for the treatment of patients with Familial CHylomicroNEmia Syndrome
    Medical condition: Familial Chylomicronemia Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10058108 Dyslipidaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-002774-34 Sponsor Protocol Number: A2581172 Start Date*: Information not available in EudraCT
    Sponsor Name:Pfizer Inc,235 East 42nd Street,New York,NY 10017
    Full Title: A 8-WEEK, OPEN-LABEL, PHASE 1 STUDY TO EVALUATE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF ATORVASTATIN IN CHILDREN AND ADOLESCENTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
    Medical condition: HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
    Disease: Version SOC Term Classification Code Term Level
    9.1 10057079 Heterozygous familial hypercholesterolemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Not Authorised) Outside EU/EEA
    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: 2020-002757-18 Sponsor Protocol Number: CKJX839C12301 Start Date*: 2020-12-21
    Sponsor Name:Novartis Pharma AG
    Full Title: Two part (double-blind inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2]) randomized multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in ad...
    Medical condition: Heterozygous Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10057079 Heterozygous familial hypercholesterolemia LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) NO (Completed) DE (Completed) SI (Ongoing) NL (Ongoing) GR (Ongoing) FR (Ongoing) IT (Ongoing) PL (Ongoing) HR (Ongoing) SK (Ongoing) CZ (Ongoing)
    Trial results: (No results available)
    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: 2004-004269-14 Sponsor Protocol Number: A5091026 Start Date*: 2005-02-21
    Sponsor Name:Pfizer AB
    Full Title: Phase 3, Multi-center, double-blind, randomized, parallel group study of the efficacy, safety, and tolerability of fixed combination torcetrapib (CP-529,414)/Atorvastatin administered orally, once ...
    Medical condition: Heterozygous Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    7.1 10057079 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) IS (Completed)
    Trial results: View results
    EudraCT Number: 2011-001483-21 Sponsor Protocol Number: KBT009 Start Date*: 2011-06-15
    Sponsor Name:Karo Bio AB
    Full Title: A Placebo-controlled, Double-blind, Randomised, Parallel-group, Long-term Phase III Trial Assessing the Safety and Efficacy of 50 µg and 100 µg/day of eprotirome in Patients with Heterozygous Famil...
    Medical condition: Heterozygous Familial Hypercholesterolaemia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10057099 Heterozygous familial hypercholesterolaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) GB (Prematurely Ended) AT (Prematurely Ended) DK (Completed) CZ (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-006130-95 Sponsor Protocol Number: A2581173 Start Date*: 2009-04-23
    Sponsor Name:PFIZER
    Full Title: “Estudio abierto, prospectivo, de tres años de duración para evaluar la eficacia, la seguridad y la tolerabilidad clínicas de la atorvastatina en niños y adolescentes con hipercolesterolemia famili...
    Medical condition: "Hipercolesterolemia familiar heterocigótica (HFHe) en niños y adolescentes" "HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN CHILDREN AND ADOLESCENTS"
    Disease: Version SOC Term Classification Code Term Level
    9.1 10057079 Heterozygous familial hypercholesterolemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) HU (Completed) BE (Completed) IT (Completed) DE (Completed) GR (Completed) SK (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-001915-29 Sponsor Protocol Number: 20110110 Start Date*: 2011-10-26
    Sponsor Name:Amgen Inc
    Full Title: A Multicenter, Controlled, Open-Label Extension (OLE) Study To Assess the Long-Term Safety and Efficacy of Evolocumab (AMG 145)
    Medical condition: Hypercholesterolaemia
    Disease: Version SOC Term Classification Code Term Level
    18.0 10027433 - Metabolism and nutrition disorders 10020603 Hypercholesterolaemia PT
    18.0 100000004850 10057099 Heterozygous familial hypercholesterolaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) SE (Completed) NO (Completed) BE (Completed) HU (Completed) GB (Completed) NL (Completed) DK (Completed) DE (Completed) ES (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2015-002276-25 Sponsor Protocol Number: 20120124 Start Date*: 2016-10-21
    Sponsor Name:Amgen Inc
    Full Title: Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects Fr...
    Medical condition: Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10057100 Homozygous familial hypercholesterolaemia LLT
    18.1 100000004850 10057099 Heterozygous familial hypercholesterolaemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) NO (Completed) HU (Completed) AT (Completed) BE (Completed) CZ (Completed) GR (Completed) ES (Completed) NL (Completed) PT (Completed) SI (Completed) PL (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2004-002627-40 Sponsor Protocol Number: P02579 Start Date*: 2005-06-15
    Sponsor Name:Schering-Plough Research Institute
    Full Title: Efficacy, Safety, and Tolerability of Ezetimibe in Coadministration With Simvastatin in the Therapy of Adolescents With Heterozygous Familial Hypercholesterolemia
    Medical condition: Adolescent (age >=10 and <=17 years) subjects with Heterozygous Familial Hypercholesterolemia (HeFH).
    Disease: Version SOC Term Classification Code Term Level
    7.0 10057099 LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) AT (Completed) DE (Completed) IT (Completed) ES (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-001917-20 Sponsor Protocol Number: R727-CL-1216.03 Start Date*: 2015-02-27
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia Undergoing Lipid A...
    Medical condition: Heterozygous Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10057079 Heterozygous familial hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-004299-69 Sponsor Protocol Number: ARCHITECT Start Date*: 2018-04-25
    Sponsor Name:Fundación Hipercolesterolemia Familiar
    Full Title: Low interventional, open and multicentric clinical trial to evaluate the effect of alirocumab on volume, architecture and composition of atheroma plaque in patients with familial hypercholesterole...
    Medical condition: Heterozygous familial hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10057099 Heterozygous familial hypercholesterolaemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-001528-39 Sponsor Protocol Number: 20090158 Start Date*: 2011-07-13
    Sponsor Name:Amgen Inc
    Full Title: "A Double-blind, Radomized, Placebo-comtrolled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Subjects with Heterozygous Familial Hypercholesterolemia"
    Medical condition: Heterozygous familial hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    13.1 10010331 - Congenital, familial and genetic disorders 10057099 Heterozygous familial hypercholesterolaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed) DE (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2021-005064-22 Sponsor Protocol Number: TA-8995-301 Start Date*: 2022-09-22
    Sponsor Name:NewAmsterdam Pharma B.V.
    Full Title: Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROOKLYN): A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Partici...
    Medical condition: dyslipidemia heterozygous familial hypercholesterolemia (HeFH)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004848 10020049 High cholesterol LLT
    20.0 100000004850 10057079 Heterozygous familial hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) NL (Ongoing) CZ (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000963-15 Sponsor Protocol Number: MATCH0.1 Start Date*: 2016-01-19
    Sponsor Name:University of Edinburgh [...]
    1. University of Edinburgh
    2. NHS Lothian
    Full Title: MAcrophage Therapy for Liver Cirrhosis (MATCH)
    Medical condition: Liver Cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004871 10024667 Liver cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2014-002277-11 Sponsor Protocol Number: 20120123 Start Date*: 2015-06-23
    Sponsor Name:Amgen Inc
    Full Title: Double-blind, Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Characterize the Efficacy, Safety, and Tolerability of 24 Weeks of Evolocumab for Low Density Lipoprotein-Choleste...
    Medical condition: Heterozygous familial hypercholesterolaemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10057079 Heterozygous familial hypercholesterolemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) ES (Completed) IT (Completed) Outside EU/EEA GR (Completed) NL (Completed) GB (Completed) AT (Completed) HU (Completed) SI (Completed) PT (Completed) PL (Completed) NO (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2008-006271-70 Sponsor Protocol Number: P05522 Start Date*: 2009-03-03
    Sponsor Name:Schering-Plough Research Institute, A Division of Schering Corporation,
    Full Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Efficacy and Safety Study of Ezetimibe Monotherapy in Children (Ages 6 to 10 Years) With Primary Hypercholesterolemia (Heterozygous Fa...
    Medical condition: -Primary Hypercholesterolemia (Heterozygous Familial [HeFH]) -Primary Hypercholesterolemia (Nonfamilial)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10057079 Heterozygous familial hypercholesterolemia LLT
    9.1 10020604 Hypercholesterolemia LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) FR (Completed) IT (Completed) GR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-002997-28 Sponsor Protocol Number: ISIS304801-CS20 Start Date*: 2021-03-17
    Sponsor Name:Akcea Therapeutics, Inc.
    Full Title: An Open-Label Study of Volanesorsen (ISIS 304801) Administered Subcutaneously to Pediatric Patients with Familial Chylomicronemia Syndrome (FCS)
    Medical condition: Familial Chylomicronemia Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10020606 Hyperchylomicronaemia PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    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.
    1  2  3  Next»
    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-Mon May 20 03:47:45 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA