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    Summary
    EudraCT Number:2013-002343-29
    Sponsor's Protocol Code Number:R727-CL-1308
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-14
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2013-002343-29
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effect and safety of a 4 week treatment plan of Alirocumab in patients with high cholesterol
    A.3.2Name or abbreviated title of the trial where available
    ODYSSEY CHOICE
    A.4.1Sponsor's protocol code numberR727-CL-1308
    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 pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post codeNY 10591
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 914847 7000
    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 nameAlirocumab
    D.3.2Product code REGN727/SAR236553
    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 INNAlirocumab
    D.3.9.1CAS number 1245916-14-6
    D.3.9.2Current sponsor codeREGN727
    D.3.9.3Other descriptive nameSAR236553
    D.3.9.4EV Substance CodeSUB74847
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Hypercholesterolemia
    E.1.1.1Medical condition in easily understood language
    High blood cholesterol level
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10020604
    E.1.2Term Hypercholesterolemia
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    *To determine the efficacy, long-term safety, and tolerability of a dosing regimen of 300 mg alirocumab q4w and its potential as a starting regimen.
    E.2.2Secondary objectives of the trial
    * To investigate the pharmacokinetic (PK)/pharmacodynamic (PD) profile of alirocumab from weekly data at steady state and evaluate patients for the development of anti-alirocumab antibodies.
    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: As main study

    Objectives: To identify genetic associations with clinical or biomarker response to PCSK9 inhibition, hyperlipidaemia of CVD
    E.3Principal inclusion criteria
    1. Men and women > age 18 or legal age of majority with elevated LDL-C.

    2. Patients not having adequate control of their hypercholesterolemia,
    defined as follows: for moderate and high CVD risk, LDL-C ≥100 mg/dL,
    and for very high CVD risk, LDL-C ≥ 70 mg/dL. Patients who are not on
    statin therapy must be at moderate CVD risk and must have LDL-C <160
    mg/dL (<4.14 mmol/L). Patients who are statin intolerant may be at
    moderate CVD risk or greater. Patients who are statin intolerant must
    have LDL-C <160 mg/dL (<4.14 mmol/L), if they are not receiving any
    other non-statin LMT. There is no upper limit for LDL-C for patients who
    are statin intolerant and are receiving clinically appropriate
    lipid-lowering therapy (as they are already on standard of care). See
    protocol for CVD risk categories and definition of statin intolerance.

    3. If on statin therapy, patients on the following medications/doses for at least 28 days prior to the screening visit are allowed: atorvastatin 40 mg or 80 mg, rosuvastatin 20 mg or 40 mg, or simvastatin 80 mg (must be on stable dose of simvastatin for at least 1 year), or their maximally tolerated dose of 1 of these 3 statins.

    4. Willing and able to comply with clinic visits and study-related procedures.

    5. Provide signed informed consent.
    E.4Principal exclusion criteria
    1. Patient with homozygous FH (clinically or by previous genotyping)
    2. Currently taking a statin that is not atorvastatin, rosuvastatin, or simvastatin
    3. Use of fibrates other than fenofibrate within 6 weeks of the screening visit
    4. Use of allowed LMTs (eg, omega-3 fatty acids, cholesterol absorption inhibitors [eg, ezetimibe], bile acid resins, niacin, and plant stanols/sterols [such as those found in Benecol®, flax seed oil, or psyllium]) that have not been at a stable dose/regimen for at least 4 weeks prior to the screening visit
    5. Use of nutraceutical products or over-the-counter therapies that may affect lipids and that have not been at a stable dose/amount for at least 4 weeks prior to the screening visit
    6. Use of red yeast rice products within 4 weeks of the screening visit or between screening and randomization visits
    7. Uncontrolled hypothyroidism
    8. Uncontrolled blood pressure (systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg) at the screening visit
    9. Patient who has received plasmapheresis treatment within 2 months prior to the screening visit, or has plans to receive it during the study
    10. Recent (within 3 months prior to the screening visit) myocardial infarction, unstable angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease
    11. Planning to undergo scheduled PCI, CABG, or carotid or peripheral revascularization during the study
    12. Known history of a hemorrhagic stroke
    13. History of New York Heart Association Class III or IV heart failure within 12 months prior to the screening visit.
    14. Newly diagnosed diabetes (within 3 months prior to the screening visit) or poorly controlled diabetes (hemoglobin A1c [HbA1c] >9% at the screening visit)
    15. History of bariatric surgery within 12 months prior to the screening visit
    16. Unstable weight, defined by a variation >5 kg within 2 months prior to the screening visit
    17. Known history of loss of function of PCSK9 (ie, genetic mutation or sequence variation)
    18. Use of systemic corticosteroids, unless used as replacement therapy for pituitary/adrenal disease with a stable regimen for at least 6 weeks prior to randomization
    19. Use of continuous estrogen or testosterone hormone replacement therapy, unless the regimen has been stable for 6 weeks prior to the screening visit and there are no plans to change the regimen during the study
    20. History of cancer within the past 5 years, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer
    21. Known history of positive test for human immunodeficiency virus (HIV)
    22. Has been previously treated with at least 1 dose of alirocumab or any other anti-PCSK9 monoclonal antibody in other clinical studies
    23. Has taken any active investigational drugs within 1 month or 5 half-lives, whichever is longer; however, patients who have taken anti-PCSK9 therapy at any time are excluded
    24. Conditions/situations such as:
     Any clinically significant abnormality identified at the time of screening that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrain assessment of endpoints, such as major systemic diseases or patients with short life expectancy.
     Patients considered by the investigator or any sub-investigator to be inappropriate for this study for any reason, eg:
    o Those patients deemed unable to meet specific protocol requirements, such as scheduled visits.
    o Those patients the investigator deems unable to administer or tolerate long-term injections.
     Investigator or any sub-investigator, pharmacist, study coordinator, other study staff, or relative thereof directly involved in the conduct of the protocol.
     Presence of any other conditions (eg, geographic or social), actual or anticipated, that the investigator feels would restrict or limit the patient’s participation for the duration of the study.
    E.5 End points
    E.5.1Primary end point(s)
    *The percent change in calculated LDL-C from baseline to week 24 for alirocumab 300 mg q4w in comparison with placebo after 24 weeks of treatment in patients with hypercholesterolemia at moderate, high, or very high CVD risk who received concomitant statin therapy.

    *The percent change in calculated LDL-C from baseline to week 24 for alirocumab 300 mg q4w in comparison with placebo after 24 weeks of treatment in patients with hypercholesterolemia who did not receive concomitant statin therapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to week 24
    E.5.2Secondary end point(s)
    * The proportion of patients reaching LDL-C goal at week 24.

    *The percent change in calculated LDL-C from baseline to week 12; similar definition and rules as for the primary efficacy endpoint, except that the calculated LDL-C at week 12 will be the LDL-C level obtained within the week 12 analysis window and during the 12-week efficacy period.

    *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 cholesterol from baseline to week 24.

    * The percent change in ApoB from baseline to week 12. Same definition and rules as for the percent change in calculated LDL-C from baseline to week 12.

    * The percent change in non-HDL-C from baseline to week 12. Same definition and rules as for the percent change in calculated LDL-C from baseline to week 12.

    * The percent change in total cholesterol from baseline to week 12. Same definition and rules as for the percent change in calculated LDL-C from baseline to week 12.

    * The proportion of patients reaching LDL-C <70 mg/dL at week 24.

    * The proportion of patients reaching LDL-C <100 mg/dL 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 Lp(a) from baseline to week 12.

    * The percent change in HDL-C from baseline to week 12.

    * The percent change in fasting TG from baseline to week 24.

    * The percent change in ApoA-1 from baseline to week 24.

    * The percent change in fasting TG from baseline to week 12. Same definition and rules as for the percent change in calculated LDL-C from baseline to week 12.

    * The percent change in ApoA-1 from baseline to week 12. Same definition and rules as for the percent change in calculated LDL-C from baseline to week 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    * At week 24

    * From baseline to week 12

    * The 12-week efficacy period

    *From baseline to week 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 No
    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 No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    Bulgaria
    Canada
    Norway
    Slovakia
    Hungary
    Israel
    Poland
    South Africa
    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 months7
    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 months8
    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: 525
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 175
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 287
    F.4.2.2In the whole clinical trial 803
    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)
    Standard of care
    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 Decision2013-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-28
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