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Clinical trials for Evolocumab

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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    42 result(s) found for: Evolocumab. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2016-002983-16 Sponsor Protocol Number: EVOLAFER01 Start Date*: 2017-05-03
    Sponsor Name:SERVICIO DE NEFROLOGIA
    Full Title: PILOT STUDY TO COMPARE THE EFFICACY OF EVOLOCUMAB VS LDL-APHERESIS IN PATIENTS WITH HYPERCHOLESTEROLEMIA
    Medical condition: FAMILIAR HYPERCHOLESTEROLEMIA
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-004656-30 Sponsor Protocol Number: ICOR-2016-05 Start Date*: 2018-10-19
    Sponsor Name:Instituto de Investigación en Ciencias de la Salud Germans Trias i Pujol (IGTP)
    Full Title: EVOlocumab in stable Heart Failure with reduced ejection fraction of ischemic etiology: EVO-HF Pilot
    Medical condition: stable coronary artery disease and stable heart failure with reduced ejection fraction
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10078289 Heart failure with reduced ejection fraction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2018-002483-11 Sponsor Protocol Number: 18HH4626 Start Date*: 2019-05-15
    Sponsor Name:Imperial College London
    Full Title: CHOlesterol Reduction with Evolocumab and coronAry microvascuLar function: The CHORAL Flow Study
    Medical condition: Coronary artery disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10022891 - Investigations 10005422 Blood cholesterol PT
    21.1 10022891 - Investigations 10002434 Angiogram coronary LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-000723-14 Sponsor Protocol Number: 20120119 Start Date*: 2014-07-11
    Sponsor Name:Amgen Inc.
    Full Title: A Double-blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate Safety and Efficacy of Evolocumab (AMG 145) in Combination With Statin Therapy in Diabetic Subjects With Hyperlipidemia...
    Medical condition: Hyperlipidemia or mixed dyslipidemia in Diabetic Subjects
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-004780-36 Sponsor Protocol Number: 20130295 Start Date*: 2016-04-22
    Sponsor Name:Amgen Inc.
    Full Title: A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease
    Medical condition: Dyslipidemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004861 10020604 Hypercholesterolemia LLT
    21.0 100000004861 10058110 Dyslipidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) PL (Completed) HU (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2014-001976-75 Sponsor Protocol Number: 20130385 Start Date*: 2014-09-11
    Sponsor Name:Amgen Inc
    Full Title: A Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Evolocumab on Cognitive Function in Patients with Clinically Evident Cardiovascular Disease and Receiving Statin Back...
    Medical condition: Dyslipidemia
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004861 10020604 Hypercholesterolemia LLT
    17.0 100000004861 10058110 Dyslipidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GR (Completed) IT (Completed) FI (Completed) EE (Completed) SK (Completed) LV (Completed) DE (Completed) LT (Completed) CZ (Completed) PT (Completed) BE (Completed) HU (Completed) DK (Completed) ES (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2016-004066-26 Sponsor Protocol Number: 20160250 Start Date*: 2017-08-16
    Sponsor Name:Amgen Inc
    Full Title: A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
    Medical condition: Dyslipidemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004861 10020604 Hypercholesterolemia LLT
    21.0 100000004861 10058110 Dyslipidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) SE (Completed) DK (Prematurely Ended) PT (Completed) BE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-001524-30 Sponsor Protocol Number: 20140128 Start Date*: 2014-12-11
    Sponsor Name:Amgen Inc.
    Full Title: A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab
    Medical condition: Hypercholesterolaemia
    Disease: Version SOC Term Classification Code Term Level
    19.0 10027433 - Metabolism and nutrition disorders 10020603 Hypercholesterolaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) IT (Completed) BE (Completed) DE (Completed) IS (Completed) GB (Completed) ES (Prematurely Ended) CZ (Completed) IE (Prematurely Ended) NL (Completed) SE (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2019-003360-45 Sponsor Protocol Number: 38RC19.186 Start Date*: 2020-01-29
    Sponsor Name:University Hospital Grenoble
    Full Title: Effect of impact of PCSK9 inhibitor on coronary microvascular dysfunction in patients with atherosclerotic cardiovascular disease proved by myocardial ischemia and needing coronarography.
    Medical condition: atherosclerotic cardiovascular disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001065-17 Sponsor Protocol Number: EXO_01 Start Date*: Information not available in EudraCT
    Sponsor Name:Fondazione IRCCS Policlinico San Matteo
    Full Title: Early treatment with evOlocumab in patients with sT-elevation myocardial Infarction undergoing primary pCi
    Medical condition: Acute myocardial infarction with persistent ST segment elevation (STEMI)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-004565-14 Sponsor Protocol Number: 20170625 Start Date*: 2019-09-13
    Sponsor Name:Amgen Inc.
    Full Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardia...
    Medical condition: Dyslipidemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004861 10058110 Dyslipidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) NL (Trial now transitioned) GB (GB - no longer in EU/EEA) SE (Trial now transitioned) HU (Trial now transitioned) DK (Trial now transitioned) DE (Trial now transitioned) PL (Trial now transitioned) BG (Trial now transitioned) ES (Ongoing) PT (Trial now transitioned) FI (Trial now transitioned) AT (Trial now transitioned) LT (Trial now transitioned) LV (Trial now transitioned) EE (Trial now transitioned) SK (Trial now transitioned) GR (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned) IS (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: 2018-001234-18 Sponsor Protocol Number: NA Start Date*: 2019-03-06
    Sponsor Name:Imperial College NHS Trust
    Full Title: Effect of EVOlocumab on CARotid plaque composition in asymptomatic carotid artery stenosis (EVOCAR-1)
    Medical condition: Carotid stenosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    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: 2016-001176-30 Sponsor Protocol Number: 20167169 Start Date*: 2016-06-15
    Sponsor Name:Clinical Research Institute, HUCH Ltd.
    Full Title: Effects of PCSK9 inhibition by Evolocumab on postprandial lipid metabolism in type 2 diabetes
    Medical condition: type 2 diabetes
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2017-004129-33 Sponsor Protocol Number: CRC2017EVO Start Date*: 2018-08-02
    Sponsor Name:Friedrich-Alexander-Universtiy Erlangen-Nürnberg, Medical Faculty
    Full Title: Randomized, double-blind, placebo controlled, parallel-group, prospective clinical study to analyse the effect of evolocumab on vascular function.
    Medical condition: atherosclerotic cardiovascular disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004866 10051615 Atherosclerotic cardiovascular disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-001398-97 Sponsor Protocol Number: 20110118 Start Date*: 2012-10-17
    Sponsor Name:Amgen Inc
    Full Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Co...
    Medical condition: Dyslipidemia
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004861 10020604 Hypercholesterolemia LLT
    18.1 100000004861 10058110 Dyslipidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) SK (Completed) PL (Completed) GR (Completed) LT (Completed) BE (Completed) IT (Completed) NL (Completed) DK (Completed) AT (Completed) HU (Completed) PT (Completed) ES (Completed) CZ (Completed) EE (Completed) IS (Completed) GB (Completed) DE (Completed) BG (Completed) SE (Completed) LV (Completed) IE (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2021-005272-19 Sponsor Protocol Number: 20190184 Start Date*: 2023-01-08
    Sponsor Name:Amgen Inc
    Full Title: EVOLVE-MI: A Pragmatic Randomized Multicenter Trial of EVOLocumab Administered Very Early to Reduce the Risk of Cardiovascular Events in Patients Hospitalized With Acute Myocardial Infarction
    Medical condition: Dyslipidemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 10027433 - Metabolism and nutrition disorders 10020604 Hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-004735-12 Sponsor Protocol Number: 20130286 Start Date*: 2017-04-06
    Sponsor Name:Amgen Inc
    Full Title: A Double Blind, Randomized, Placebo Controlled, Multicenter Study toEvaluate Safety, Tolerability, and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects with HIV and with Hyperlipidemia and/or ...
    Medical condition: HIV and hyperlipidemia or mixed dyslipidemia.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10020604 Hypercholesterolemia LLT
    20.1 100000004861 10020667 Hyperlipidemia LLT
    20.0 100000004848 10020180 HIV positive LLT
    20.0 100000004861 10058110 Dyslipidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) PT (Completed) GB (Completed) BE (Completed) ES (Completed) GR (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-003815-37 Sponsor Protocol Number: MDCO-PCS-16-01 Start Date*: 2017-02-24
    Sponsor Name:Novartis Pharma AG
    Full Title: An open label, active comparator extension trial to assess the effect of long term dosing of inclisiran and evolocumab given as subcutaneous injections in subjects with high cardiovascular risk and...
    Medical condition: Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004861 10020604 Hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) NL (Ongoing)
    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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