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    Summary
    EudraCT Number:2012-001221-27
    Sponsor's Protocol Code Number:R727-CL-1119
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-05
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-001221-27
    A.3Full title of the trial
    A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients with Primary Hypercholesterolemia Who are Intolerant to Statins
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of REGN727/SAR236553 in patients with primary hypercholesterolemia who are intolerant to statins
    A.3.2Name or abbreviated title of the trial where available
    Odyssey - Alternative
    A.4.1Sponsor's protocol code numberR727-CL-1119
    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 pointDan Gipe, MD
    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 914 847
    B.5.6E-maildan.gipe@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 INNAlirocumab
    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 CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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 Zetia
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme
    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 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.3.9.4EV Substance CodeAS2
    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.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 Atorvastatin Calcium
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    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 Atovastatin
    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.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 primary hypercholesterolemia and moderate, high or very high cardiovascular (CV) risk who are intolerant to statins
    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 19.0
    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
    The primary objective of the study is to demonstrate the reduction of low-density lipoprotein (LDL) cholesterol (LDL-C) by REGN727 in comparison with ezetimibe (EZE) 10 mg PO QD (taken orally once per day) after 24 weeks in patients with primary hypercholesterolaemia (heterozygous familial hypercholesterolemia [heFH] and non-familial hypercholesterolaemia [FH]) who are intolerant to statins.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of REGN727 75 mg in comparison with EZE on LDL-C after 12 weeks of treatment
    - To evaluate the effect of REGN727 on other lipid parameters (ie, ApoB, non-HDL-C, total-C, Lp(a), HDL-C, TG levels, and ApoA-1 levels)
    - To evaluate the safety and tolerability of REGN727, including the characterisation of the incidence rate and treatment withdrawal rate of skeletal muscle-related adverse events (AEs)
    - To evaluate the development of anti-REGN727 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: A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients with Primary Hypercholesterolemia Who are Intolerant to Statins

    Objectives: to identify genetic associations with clinical or biomarker response to PCSK9 inhibition, hyperlipidaemia, or CVD (Cardiovascular Disease)
    E.3Principal inclusion criteria
    A patient must meet the following criteria to be eligible for inclusion in the study:
    1. Patients with primary hypercholesterolaemia (heFH* or non-FH) with moderate, high or very high CV risk** and a history of statin intolerance***
    * Diagnosis of heFH must be made either by genotyping or by clinical criteria. For patients who are not genotyped, the clinical diagnosis must be a certain/definite diagnosis and maybe based on either the Simon Broome criteria or the WHO/Dutch Lipid Network criteria.
    ** Moderate, high, and very high CV risk.
    *** Definition of statin intolerance: The inability to tolerate at least 2 statins: 1 statin at the lowest daily starting dose (defined as rosuvastatin 5 mg, atorvastatin 10 mg, simvastatin 10 mg, lovastatin 20 mg, pravastatin 40 mg, fluvastatin 40 mg or pitavastatin 2 mg), AND another statin at any dose, due to skeletal muscle-related symptoms, other than those due to strain or trauma, such as pain, aches, weakness, or cramping, that began or increased during statin therapy and stopped when statin therapy was discontinued.

    NOTE: Patients not receiving a daily regimen of a statin (eg, 1 to 3 time weekly) will also be considered as not able to tolerate a daily dose and will be eligible to enroll in the study if they cannot tolerate a cumulative weekly statin dose of 7 times the lowest approved tablet size and the criteria outlined above are also met.

    2. Provide signed informed consent
    E.4Principal exclusion criteria
    1. Calculated serum LDL-C <70 mg/dL (1.81 mmol/L) and very high CV risk at the screening visit (week -7)
    2. Calculated serum LDL-C <100 mg/dL (2.59 mmol/L) and high or moderate CV risk at the screening visit (week -7)
    3. A 10-year fatal CVD risk SCORE <1% (ESC/EAS 2011) at the screening visit (week 7)
    4. Use of a statin that is at or above the lowest approved daily dose within 4 weeks prior to the screening visit (week -7)
    5. Experienced skeletal muscle-related AE(s), other than those due to strain or trauma during the 4-week single-blind placebo run-in
    6. Experiencing a skeletal muscle-related AE(s), other than those due to strain or trauma at the time of screening (week -7), start of single-blind placebo run-in period (week -4), or baseline (day 1/week 0)
    7. Not on a stable dose of LMT for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit (week -7) or from screening to randomisation, as applicable
    8. Use of fibrates, other than fenofibrate, within 6 weeks of the screening visit(week -7)
    9. Use of nutraceuticals or over-the-counter therapies known to affect lipids, at a dose/amount that has not been stable for at least 4 weeks prior to the screening visit (week -7) or between the screening and randomisation visits
    10. Use of red yeast rice from the screening visit (week -7) to the end of study visit
    11. Use of analgesics for which the dose is not planned to be stable from the screening visit to week 32
    12. Diagnosis of fibromyalgia
    13. History of severe neuropathic pain
    14. History of rheumatological disease associated with symptoms that may be confounded with symptoms of statin intolerance, eg, rheumatoid arthritis
    15. History of myalgia or myopathy that began or increased during treatment with LMT, other than statin therapy, and stopped when the LMT was discontinued
    16. Known history of seizure disorder
    17. History of previous transplant surgery
    18. Use of medications that require intramuscular administration, or planned intramuscular injections during the study
    19. Known history of myopathy, other than statin-associated myopathy
    20. History of rhabdomyolysis (defined as evidence of organ damage with creatine kinase >10,000 IU/L)
    21. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
    Note: Patients on thyroid replacement therapy can be included if the dosage of thyroxine has been stable for at least 12 weeks prior to screening and the thyroid-stimulating hormone (TSH) level is within the normal range of the central laboratory at the screening visit (week - 7)
    22. History of bariatric surgery within 12 months prior to the screening visit(week -7)
    23. Unstable weight (variation >5 kg) within 2 months prior to the screening visit (week -7)
    24. Known history of loss of function of PCSK9 (ie, genetic mutation or sequence variation)
    25. Known history of homozygous FH
    26. Newly diagnosed (within 3 calendar months prior to randomization visit [week 0/day 1]) diabetes mellitus or poorly controlled (hemoglobin A1c [HbA1c] >9%) diabetes
    27. 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 Note: Topical, intra-articular, nasal, inhaled and ophthalmic steroid therapies are not considered as ‘systemic’ and are allowed
    28. Use of estrogen or testosterone therapy unless the regimen has been stable in the past 6 weeks prior to the screening visit (week -7), and no plans to change the regimen during the study
    29. History of undergoing plasmapheresis treatment within 2 months prior to the screening visit (week -7), or plans to undergo plasmapheresis during the study
    30. Systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg at the screening visit (week -7) or time of randomization (week 0/day 1)
    31. History of a MI, unstable angina leading to hospitalization, CABG, PCI, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, carotid revascularisation, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior to the screening visit (week -7)
    32. Patients currently participating in a rehabilitation or exercise program
    33. History of New York Heart Association Class III or IV heart failure within the past 12 months
    34. Age <18 years or legal age of majority at the screening visit (week -7), whichever is greater
    35. Not previously instructed on a cholesterol-lowering diet prior to the screening visit (week -7)
    36. Known history of a hemorrhagic stroke
    37. 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.
    38. Known history of HIV positivity
    39. Use of any active investigational drugs within 1 month or 5 half lives, whichever is longer.
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to week 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, ie, LDL-C <70 mg/dL (1.81 mmol/L) in case of very high CV risk or LDL-C <100 mg/dL (2.59 mmol/L) for patients with moderate or high CV risk.
    - The proportion of patients reaching LDL-C <70 mg/dL (1.81 mmol/L) 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.

    OTHER ENDPOINTS
    - Anti-REGN727 antibody status (positive/negative) and titers assessed throughout the study.
    - The percent change in high sensitivity C-reactive protein (hs-CRP) from baseline toweek 24.
    - The absolute change in HbA1c (%) from baseline to week 24.
    - Long-term safety assessments in the open-label treatment period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    from baseline to weeks 12 and 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
    Double-Dummy, Active-Controlled
    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 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 EEA33
    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
    Austria
    Belgium
    Canada
    France
    Ireland
    Israel
    Italy
    Netherlands
    Norway
    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 years4
    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 years4
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days29
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 250
    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)
    Once the study has finished the investigational drug (REGN727) will not be available to the patient. The Investigator will refer the patient or discuss with the patient the most suitable continued treatment options and resume their usual lipid lowering medication.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-05-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-29
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