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Clinical trials for Alirocumab

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 ).  
     
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    31 result(s) found for: Alirocumab. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2018-000981-12 Sponsor Protocol Number: ALIROCKS_05MAR2018_V3 Start Date*: 2018-05-11
    Sponsor Name:Medical University of Graz
    Full Title: A PILOT STUDY INVESTIGATING THE EFFECTS OF LIPID-THERAPY INTENSIFICATION WITH ALIROCUMAB ON ENDOTHELIAL FUNCTION, CAROTID ARTERIES, LIPOPROTEIN PARTICLE SUBFRACTIONS, INFLAMMATION AND POST-PRANDIAL...
    Medical condition: Primary Hypercholesterolemia in secondary prevention after an acute atherosclerotic, ischaemic cardiovascular event for patients with diagnostically confirmed coronary heart disease and / or periph...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-001903-60 Sponsor Protocol Number: EFC14643 Start Date*: 2018-07-04
    Sponsor Name:Sanofi-aventis recherche & développement
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Heterozygous Famil...
    Medical condition: Hypercholesterolaemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10020603 Hypercholesterolaemia PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) FR (Completed) IT (Completed) DE (Completed) AT (Completed) Outside EU/EEA NL (Completed) HU (Completed) SI (Completed) ES (Completed) PL (Completed) FI (Completed) BG (Completed) CZ (Completed) NO (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: 2011-005698-21 Sponsor Protocol Number: EFC11570 Start Date*: 2013-03-05
    Sponsor Name:sanofi-aventis Recherche & Développement
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recentl...
    Medical condition: Acute coronary syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 10007541 - Cardiac disorders 10051592 Acute coronary syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) BE (Completed) NO (Completed) EE (Completed) LT (Completed) HU (Completed) ES (Completed) CZ (Completed) LV (Completed) DE (Completed) IT (Completed) BG (Completed) FI (Completed) AT (Completed) PT (Completed) DK (Completed) NL (Completed) PL (Completed) SK (Completed) SI (Completed) HR (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2015-001934-19 Sponsor Protocol Number: LPS14354 Start Date*: 2016-02-15
    Sponsor Name:Sanofi-Aventis Groupe
    Full Title: A Randomized, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab Versus Usual Care in Patients with Type 2 Diabetes and Mixed Dyslipidemia at High Cardiovascular Ris...
    Medical condition: Dyslipidemia
    Disease: Version SOC Term Classification Code Term Level
    18.1 10027433 - Metabolism and nutrition disorders 10058108 Dyslipidaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DE (Completed) GB (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003766-85 Sponsor Protocol Number: DFI14223 Start Date*: 2017-08-03
    Sponsor Name:sanofi-aventis recherche&developpement
    Full Title: An 8-Week Open-Label, Sequential, Repeated Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Heterozygous Familial Hypercholesterolemia Followed ...
    Medical condition: Hypercholesterolaemia
    Disease: Version SOC Term Classification Code Term Level
    19.1 10027433 - Metabolism and nutrition disorders 10020603 Hypercholesterolaemia PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) ES (Completed) CZ (Completed) FR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-002572-40 Sponsor Protocol Number: LTS13463 Start Date*: 2013-11-28
    Sponsor Name:sanofi-aventis recherche et développement
    Full Title: Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients with Heterozygous Familial Hypercholesterol...
    Medical condition: na
    Disease: Version SOC Term Classification Code Term Level
    16.0 10027433 - Metabolism and nutrition disorders 10020603 Hypercholesterolaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed) BE (Completed) NL (Completed) GB (Completed) NO (Completed) CZ (Completed) FI (Completed) AT (Completed) DE (Completed) DK (Completed) PT (Completed) RO (Completed) HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2015-000620-28 Sponsor Protocol Number: LPS14245 Start Date*: 2015-07-06
    Sponsor Name:sanofi-aventis groupe
    Full Title: A Multi-Country, Multicenter, Single-Arm, Open-Label Study to Document the Safety, Tolerability and Effect of Alirocumab on atherogenic lipoproteins in High Cardio-Vascular Risk Patients With Sever...
    Medical condition: Hypercholesterolemia
    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: DK (Completed) CZ (Completed) SK (Completed) BE (Completed) IT (Completed) HU (Completed) AT (Completed) DE (Completed) FR (Completed) SE (Completed) ES (Completed) FI (Completed) PL (Completed) GR (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2017-001502-15 Sponsor Protocol Number: 2016-01382 Start Date*: 2017-12-13
    Sponsor Name:Insel Gruppe AG - Inselspital
    Full Title: Effects of the PCSK9 Antibody AliroCuMab on Coronary Atherosclerosis in PatieNts with Acute Myocardial Infarction. A Serial, Multivessel, Intravascular Ultrasound, Near-Infrared Spectroscopy And Op...
    Medical condition: Patients presenting with acute myocardial infarction (non-ST-elevation myocardial infarction or acute ST-elevation myocardial infarction) and with elevated cholesterol levels.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10028597 Myocardial infarction acute LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) AT (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
    EudraCT Number: 2013-002659-14 Sponsor Protocol Number: EFC13786 Start Date*: 2013-12-23
    Sponsor Name:sanofi-aventis Recherche & Développement
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Alirocumab in Patients with Primary Hypercholesterolemia Not Treated With a Statin
    Medical condition: Hypercholesterolaemia
    Disease: Version SOC Term Classification Code Term Level
    18.1 10027433 - Metabolism and nutrition disorders 10020603 Hypercholesterolaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NL (Completed) ES (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2017-002297-39 Sponsor Protocol Number: EFC14660 Start Date*: 2018-09-19
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia
    Medical condition: Homozygous Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10020603 Hypercholesterolaemia PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NO (Completed) FR (Completed) NL (Completed) IT (Completed) DK (Completed) AT (Completed) SI (Completed) ES (Completed) BG (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004794-41 Sponsor Protocol Number: Vista Start Date*: 2017-03-02
    Sponsor Name:Academical medical centre, dep of internal medicine
    Full Title: Arterial wall inflammation measured with 18F-FDG PET/CT in patients with statin intolerance before and after treatment with a PCSK-9 inhibitor
    Medical condition: Patients with CV-risk and statin intolerance due to statin-associated muscle symptoms (SAMS)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-000351-95 Sponsor Protocol Number: R727-CL-1628 Start Date*: 2017-07-18
    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 HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
    Medical condition: HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10057080 Homozygous familial hypercholesterolemia LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) AT (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-000799-92 Sponsor Protocol Number: LPS14355 Start Date*: 2015-12-31
    Sponsor Name:sanofi-aventis Groupe
    Full Title: A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of Alirocumab in insulin treated patients with type 1 or type 2 diabetes and with hyperchole...
    Medical condition: Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004861 10020604 Hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (Completed) NL (Completed) AT (Completed) FR (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-003483-12 Sponsor Protocol Number: 1.00 Start Date*: 2018-06-28
    Sponsor Name:Verein zur Förderung der Forschung auf dem Gebiet der Arteriosklerose, Thrombose und vaskulären Biologie (ATVB)
    Full Title: Pilot Study: The LIPL-PLATELET Study LIPid paneLs And PLATELET activity in coronary heart disease
    Medical condition: the platelet activity in patients with coronary heart disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-002343-29 Sponsor Protocol Number: R727-CL-1308 Start Date*: 2013-10-21
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients with Primary Hypercholesterolemia
    Medical condition: Primary Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004861 10020604 Hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) SK (Completed) BG (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2016-003253-15 Sponsor Protocol Number: 58836 Start Date*: 2017-01-25
    Sponsor Name:Franciscus Gasthui
    Full Title: MODULATION OF POSTPRANDIAL LIPEMIA, INFLAMMATION, AND VASCULAR FUNCTION BY PCSK9 INHIBITION IN DIABETES.
    Medical condition: Diabetes mellitus type 2
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    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: 2017-003170-13 Sponsor Protocol Number: R1500-CL-1719 Start Date*: 2018-03-15
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: An open-label study to evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia
    Medical condition: Homozygous familial hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004861 10020604 Hypercholesterolemia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed) CZ (Completed) FR (Completed) GR (Completed) GB (GB - no longer in EU/EEA) AT (Completed) IT (Completed)
    Trial results: View results
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