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Clinical trials for Heterozygous Familial Hypercholesterolemia

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    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).

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    60 result(s) found for: Heterozygous Familial Hypercholesterolemia. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2015-004003-23 Sponsor Protocol Number: ISIS703802 Start Date*: 2016-09-28
    Sponsor Name:Ionis Pharmaceuticals, Inc.
    Full Title: A Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of ISIS 703802, Targeting ANGPTL3, Administered S...
    Medical condition: Heterozygous familial hypercholesterolemia and Homozygous familial hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10054380 Familial hypercholesterolemia LLT
    19.0 100000004850 10057080 Homozygous familial hypercholesterolemia LLT
    19.0 100000004850 10057079 Heterozygous familial hypercholesterolemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (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: 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: 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: 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: 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 (Completed) NL (Completed) GR (Completed) FR (Completed) IT (Completed) PL (Completed) HR (Completed) SK (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2012-001365-32 Sponsor Protocol Number: 20110117 Start Date*: 2012-09-06
    Sponsor Name:Amgen Inc
    Full Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, 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
    15.0 10010331 - Congenital, familial and genetic disorders 10057079 Heterozygous familial hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) NL (Completed) SE (Completed) GB (Completed) DE (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: 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: 2022-002316-23 Sponsor Protocol Number: CKJX839C12001B Start Date*: 2023-01-16
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: An open-label, single arm, multicenter extension study to evaluate long-term safety and tolerability of inclisiran in participants with heterozygous or homozygous familial hypercholesterolemia who...
    Medical condition: Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10049593 Familial hypercholesterolaemia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Trial now transitioned) NO (Trial now transitioned) DE (Ongoing) NL (Trial now transitioned) HU (Trial now transitioned) GR (Trial now transitioned) FR (Trial now transitioned) SI (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-004084-31 Sponsor Protocol Number: 1002-041 Start Date*: 2023-01-23
    Sponsor Name:Esperion Therapeutics, Inc.
    Full Title: AN OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF BEMPEDOIC ACID IN PEDIATRIC PATIENTS (6 TO 17 YEARS OF AGE) WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
    Medical condition: HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
    Disease: Version SOC Term Classification Code Term Level
    21.0 10027433 - Metabolism and nutrition disorders 10020604 Hypercholesterolemia LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10054380 Familial hypercholesterolemia LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10057079 Heterozygous familial hypercholesterolemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Ongoing) NL (Trial now transitioned) DK (Trial now transitioned)
    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: 2018-002810-11 Sponsor Protocol Number: R727-CL-1609 Start Date*: 2018-11-19
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: Long Term Safety Study of PRALUENT in Patients with Heterozygous Familial Hypercholesterolemia or with Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk and Previously Enr...
    Medical condition: Heterozygous Familial Hypercholesterolemia or Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10054380 Familial hypercholesterolemia LLT
    20.1 100000004861 10020604 Hypercholesterolemia LLT
    20.0 10007541 - Cardiac disorders 10068617 Coronary heart disease LLT
    20.0 10007541 - Cardiac disorders 10007649 Cardiovascular disorder PT
    20.0 100000004850 10057079 Heterozygous familial hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Prematurely Ended) BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-001443-49 Sponsor Protocol Number: MK0524A-158 Start Date*: 2012-11-20
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ER Niacin/Laropiprant in Adolescents with Heterozygous Familial Hypercholesterolemia
    Medical condition: Heterozygous Familial Hypercholesterolaemia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10058108 Dyslipidaemia PT
    14.1 10027433 - Metabolism and nutrition disorders 10020603 Hypercholesterolaemia PT
    14.1 100000004850 10057099 Heterozygous familial hypercholesterolaemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) Outside EU/EEA
    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: 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: 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: 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: 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
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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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