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    Summary
    EudraCT Number:2012-002344-24
    Sponsor's Protocol Code Number:R727-CL-1110
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-11-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-002344-24
    A.3Full title of the trial
    A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Atorvastatin versus Ezetimibe Added-on to Atorvastatin versus Atorvastatin Dose Increase versus Switch to Rosuvastatin in Patients Who are Not Controlled on Atorvastatin
    Estudio randomizado, doble ciego para evaluar la eficacia y la seguridad de REGN727 añadido a atorvastatina en comparación con ezetimiba, añadido a atorvastatina en comparación con el aumento de dosis de atorvastatina y añadido a atorvastatina en comparación con el cambio de tratamiento a rosuvastatina en pacientes que no están controlados con atorvastatina.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of REGN727/SAR236553 added-on to Atorvastatin versus Ezetimibe added-on to Atorvastatin versus Atorvastatin dose increase versus switch to Rosuvastatin in patients who are not controlled on Atorvastatin
    Eficacia y la seguridad de REGN727 añadido a atorvastatina en comparación con ezetimiba, añadido a atorvastatina en comparación con el aumento de dosis de atorvastatina y añadido a atorvastatina en comparación con el cambio de tratamiento a rosuvastatina en pacientes que no están controlados con atorvastatina.
    A.3.2Name or abbreviated title of the trial where available
    Odyssey Options I
    A.4.1Sponsor's protocol code numberR727-CL-1110
    A.5.4Other Identifiers
    Name:IND numberNumber:105574
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointStephen Donahue, MD
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown, NY
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019148475672
    B.5.6E-mailstephen.donahue@regeneron.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameREGN727/SAR236553
    D.3.2Product code REGN727
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREGN 727
    D.3.9.1CAS number 1245916-14-6
    D.3.9.2Current sponsor codeREGN727 (SAR236553)
    D.3.9.3Other descriptive nameREGN727 (SAR236553)
    D.3.9.4EV Substance CodeSUB74847
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Atorvastatin Calcium
    D.2.1.1.2Name of the Marketing Authorisation holderRanbaxy
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAtorvastatin
    D.3.2Product code Atorvastatin
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAtorvastatin Calcium
    D.3.9.1CAS number 134523-03-8
    D.3.9.2Current sponsor codeAtorvastatin
    D.3.9.3Other descriptive nameAtorvastatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 80
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name CRESTOR
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRosuvastatin
    D.3.2Product code Rosuvastatin
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRosuvastatin Calcium
    D.3.9.1CAS number 147098-20-2
    D.3.9.2Current sponsor codeRosuvastatin
    D.3.9.3Other descriptive nameRosuvastatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ezetrol
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEzetimibe
    D.3.2Product code EZE
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEzetimibe
    D.3.9.1CAS number 163222-33-1
    D.3.9.2Current sponsor codeEZE
    D.3.9.3Other descriptive nameEzetimibe
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Non-familial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH) at high CV risk who are not adequately controlled with atorvastatin (20mg or 40mg) with or without other lipid-modifying therapy (LMT) (excluding EZE)
    Pacientes con un riesgo CV elevado, con hipercolesterolemia no familiar o hipercolesterolemia familiar heterocigota (HFH) que no están controlados adecuadamente con atorvastatina (20 mg o 40 mg), con otro TML o sin él (a excepción de la EZE).
    E.1.1.1Medical condition in easily understood language
    High blood cholesterol level
    Nivel de colesterol en sangre elevado
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10020603
    E.1.2Term Hypercholesterolaemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by REGN727 as add-on therapy to atorvastatin in comparison with ezetimibe (EZE) as add-on therapy to atorvastatin, in comparison with doubling the atorvastatin dose, or in comparison with a therapy switch from atorvastatin to rosuvastatin, after 24 weeks of treatment
    El objetivo principal del estudio es analizar la reducción del colesterol transportado por lipoproteínas de baja densidad (C-LDL) producido por REGN727 como tratamiento complementario de atorvastatina, en comparación con ezetimiba (EZE) como tratamiento complementario a la atorvastatina, en comparación con el doble de la dosis de atorvastatina o en comparación con un cambio de tratamiento, de atorvastatina a rosuvastatina, transcurridas 24 semanas de tratamiento en pacientes con hipercolesterolemia con un riesgo cardiovascular (CV) elevado.
    E.2.2Secondary objectives of the trial
    -To evaluate the reduction of LDL-C by REGN727 75 mg as add-on therapy to atorvastatin in comparison with EZE as add-on therapy to atorvastatin, in comparison with doubling of the atorvastatin dose, or in comparison with a switch from atorvastatin to rosuvastatin after 12 weeks of treatment.
    -To evaluate the effect of REGN727 on other lipid parameters eg, apolipoprotein (Apo) B, non-high-density lipoprotein cholesterol (HDL-C), total-cholesterol (C), lipoprotein a (Lp[a]), HDL-C, triglycerides (TG) levels, and ApoA-1 levels.
    -To evaluate the safety and tolerability of REGN727.
    -To evaluate the development of anti-REGN727 drug antibodies (ADA).
    -Evaluar la disminución que produce REGN727 75 mg del C-LDL como tratamiento complementario de la atorvastatina, en comparación con EZE como tratamiento complementario a la atorvastatina, en comparación con el doble de la dosis de atorvastatina o en comparación con un cambio de tratamiento de atorvastatina a rosuvastatina, transcurridas 12 semanas de tratamiento.
    -Evaluar el efecto de REGN727 en otros parámetros lipídicos (p. ej., apolipoproteína (Apo) B, colesterol no transportado por lipoproteínas de alta densidad [C-no-HDL], colesterol total [C-total], lipoproteína (a) [Lp(a)], C-HDL, nivel de triglicéridos [TG] y nivel de apolipoproteína A-1 [Apo A-1]).
    -Evaluar la seguridad y la tolerabilidad de REGN727.
    -Evaluar el desarrollo de anticuerpos anti- REGN727 (anti-REGN727 drug antibodies ,ADA).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Atorvastatin versus Ezetimibe Added-on to Atorvastatin versus Atorvastatin Dose Increase versus Switch to Rosuvastatin in Patients Who are Not Controlled on Atorvastatin.
    Objectives: to identify genetic associations with clinical or biomarker response to PCSK9 inhibition, hyperlipidemia, or CVD. If needed, samples may also be used to identify markers associated with toxicity.
    Estudio randomizado, doble ciego para evaluar la eficacia y la seguridad de REGN727 añadido a atorvastatina en comparación con ezetimiba, añadido a atorvastatina en comparación con el aumento de dosis de atorvastatina y añadido a atorvastatina en comparación con el cambio de tratamiento a rosuvastatina en pacientes que no están controlados con atorvastatina.
    Objetivos: identificar asociaciones genéticas con la respuesta clínica o biomarcador para PCSK9 inhibición, hiperlipidemia, o CVD. Si es necesario, las muestras también se puede utilizar para identificar los marcadores asociados con la toxicidad.
    E.3Principal inclusion criteria
    1. A patient must meet either 1a or 1b to be eligible for inclusion in the study:
    a. Patients with screening (visit 1) LDL-C ?70 mg/dL (1.81 mmol/L) who are not adequately controlled with a 20 mg or 40 mg stable daily dose of atorvastatin for at least 4 weeks before the screening visit (visit 1), with or without other LMT (excluding EZE). Patients with heFH* or non-FH must also have a history of documented CHD (defined below), or non-CHD CVD (defined below), or diabetes mellitus with target organ damage.
    OR
    b. Patients with screening (visit 1) LDL-C ?100 mg/dL (2.59 mmol/L) who are not adequately controlled with a 20 mg or 40 mg daily dose of atorvastatin for at least 4 weeks before the screening visit (visit 1), with or without other LMT (excluding EZE). Patients must also have heFH*, or have non-FH, without CHD or non-CHD CVD, but with a calculated 10-year fatal CVD risk SCORE ?5%, or with moderate CKD, or with diabetes mellitus but no target organ damage.
    Note: Details for the inclusion criteria are provided below.
    2. Provide signed informed consent
    1. El paciente debe cumplir el criterio 1a o 1b para ser apto para su inclusión en el estudio:
    a. Pacientes que en el screening (Visita 1) presenten valores de C-LDL ? 70 mg/dl (1,8 mmol/l) que no estén siendo controlados adecuadamente con una dosis diaria estable de 20 mg o 40 mg de atorvastatina durante un mínimo de 4 semanas antes de la visita del screening (Visita 1), con otro TML o sin él (a excepción de EZE). Los pacientes con HFH* o HNF también deben tener antecedentes de CPC documentada (definida a continuación) o ECV NO-CPC (definida a continuación) o diabetes mellitus con lesión orgánica.
    O
    b. Pacientes que en el screening (Visita 1) presenten valores de C-LDL ? 100 mg/dl (2,59 mmol/l) que no estén siendo controlados adecuadamente con una dosis diaria de 20 mg o 40 mg de atorvastatina durante un mínimo de 4 semanas antes de la visita del screening (Visita 1), con otro TML o sin él (a excepción de EZE). Los pacientes también deben tener HFH* o HNF, sin CPC o ECV NO-CPC, pero con un riesgo de ECV mortal calculado en 10 años ? 5 % o una NPC o diabetes mellitus sin lesión orgánica.
    Nota: A continuación se indican los detalles de los criterios de inclusión.
    2. Entregar el consentimiento informado firmado.
    E.4Principal exclusion criteria
    LDL-C <70 mg/dL (<1.81 mmol/L) in patients with CVD
    LDL-C <100 mg/dL (<2.59 mmol/L) in patients without CVD, but with other risk factors
    LDL-C >250 mg/dL or TG >400 mg/dL
    Homozygous FH or patients receiving plasmapheresis
    CV event within 3 months prior to screening
    NYHA Class III or IV heart failure
    History of hemorrhagic stroke
    Uncontrolled endocrine disease known to influence serum lipids
    Any clinically significant abnormality that in the judgment of the investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases, patients with short life expectancy, patients who cannottolerate subcutaneous injections.
    Use of ezetimibe or red yeast rice products within 4 weeks of screening
    Use of systemic corticosteroids or use of fibrates, other than fenofibrate within 6 weeks of the screening
    eGFR <30 mL/min/1.73m2
    ALT or AST aminotransferase >3 x upper limit of normal (ULN)
    CPK >3 x ULN
    TSH < lower limit of normal (LLN)
    Hypersensitivity to monoclonal antibody therapeutics
    Pregnant or breast-feeding women
    Women of childbearing potential with no effective contraceptive method of birth control
    Paciente con C-LDL < 70 mg/dl con antecedentes de CPC o ECV NO-CPC documentadas
    Paciente con C-LDL < 100 mg/dl y sin antecedentes de CPC o ECV NO-CPC documentadas, pero con otros factores de riesgo
    LDL-C >250 mg/dL o TG >400 mg/dL
    HF homocigótica o pacientes que se hayan sometido a una plasmaféresis en los 2 meses anteriores al screening.
    insuficiencia cardiaca (NYHA clase III o IV) en los últimos 12 meses
    Antecedentes conocidos de ictus hemorrágico
    Presencia de cualquier enfermedad endocrina no controlada
    Cualquier anomalía clínicamente significativa identificada en el momento del screening que, a juicio del Investigador o cualquier Investigador adjunto, impida la realización segura del estudio o limite la evaluación de los criterios de valoración, como por ejemplo, enfermedades sistémicas graves o pacientes con una esperanza de vida corta, o se consideren que son incapaces de administrarse o tolerar las inyecciones durante un período largo de tiempo.
    Uso de ezetimibe o productos a base de arroz de levadura roja en las 4 semanas previas a la visita del screening
    Uso de corticoesteroides sistémicos o fibratos que no sean fenofibratos en las 6 semanas previas a la visita del screening
    FGe < 30 ml/min/1,73 m2
    ALAT o ASAT > 3 x límite superior de normalidad (LSN)
    CPK > 3 x LSN
    TSH < límite inferior de normalidad (LIN)
    Hipersensibilidad conocida a medicamentos con anticuerpos monoclonales
    Mujeres embarazadas o en período de lactancia.
    Mujeres en edad fértil que no estén protegidas con un método anticonceptivo eficaz y/o que no estén dispuestas o no puedan someterse a una prueba de embarazo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percent change in calculated LDL-C from baseline to week 24, which is defined as: 100x (calculated LDL-C value at week 24 - calculated LDL-C value at baseline)/calculated LDL-C value at baseline.
    El parámetro principal de la eficacia es el cambio porcentual del C-LDL calculado desde el inicio hasta la Semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to week 24
    Desde el inicio hasta la Semana 24.
    E.5.2Secondary end point(s)
    - The percent change in calculated LDL-C from baseline to week 12
    - The percent change in ApoB from baseline to week 24.
    - The percent change in non-HDL-C from baseline to week 24.
    - The percent change in total-C from baseline to week 24.
    - The percent change in ApoB from baseline to week 12.
    - The percent change in non-HDL-C from baseline to week 12.
    - The percent change in total-C from baseline to week 12.
    - The proportion of patients reaching LDL-C goal at week 24
    - The percent change in Lp(a) from baseline to week 24.
    - The percent change in HDL-C from baseline to week 24.
    - The percent change in HDL-C from baseline to week 12.
    - The percent change in Lp(a) from baseline to week 12.
    - The percent change in fasting TG from baseline to week 24.
    - The percent change in fasting TG from baseline to week 12.
    - The percent change in ApoA-1 from baseline to week 24.
    - The percent change in ApoA-1 from baseline to week 12.
    -Cambio porcentual del C-LDL calculado desde el inicio hasta la Semana 12.
    -Cambio porcentual del nivel de Apo B desde el inicio hasta la Semana 24.
    -Cambio porcentual del C-no-HDL desde el inicio hasta la Semana 24.
    -Cambio porcentual del C-total desde el inicio hasta la Semana 24.
    -Cambio porcentual del nivel de Apo B desde el inicio hasta la Semana 12.
    -Cambio porcentual del C-no-HDL desde el inicio hasta la Semana 12.
    -Cambio porcentual del C-total desde el inicio hasta la Semana 12.
    -La proporción de pacientes que alcancen el nivel de C-LDL objetivo en la Semana 24.
    -Cambio porcentual de la Lp(a) desde el inicio hasta la Semana 24.
    -Cambio porcentual del nivel de C-HDL desde el inicio hasta la Semana 24.
    -Cambio porcentual del nivel de C-HDL desde el inicio hasta la Semana 12.
    -Cambio porcentual de la Lp(a) desde el inicio hasta la Semana 12.
    -Cambio porcentual de TG en ayunas desde el inicio hasta la Semana 24.
    -Cambio porcentual de TG en ayunas desde el inicio hasta la Semana 12.
    -Cambio porcentual del nivel de Apo A-1 desde el inicio hasta la Semana 24.
    -Cambio porcentual del nivel de Apo A-1 desde el inicio hasta la Semana 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to week 12 or week 24
    Desde el inicio hasta la Semana 24.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Active-comparator
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial7
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    France
    Germany
    Italy
    Mexico
    New Zealand
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 420
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-11
    P. End of Trial
    P.End of Trial StatusOngoing
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