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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

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    Summary
    EudraCT Number:2012-004208-37
    Sponsor's Protocol Code Number:20120153
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-22
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2012-004208-37
    A.3Full title of the trial
    A Double-Blind, Randomized, Multi-Center, Placebo-Controlled, Parallel Group Study to Determine the Effects of Evolocumab (AMG-145) Treatment on Atherosclerotic Disease Burden As Measured By Intravascular Ultrasound in Patients Undergoing Coronary Catheterization
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at the effect of AMG 145 on the build up of a waxy substance (plaque) in the arteries of the heart, using a method to see inside the heart.
    A.3.2Name or abbreviated title of the trial where available
    GLAGOV
    A.4.1Sponsor's protocol code number20120153
    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 SponsorAmgen 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 supportAgmen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post code(CH-)6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfoInternational@amgen.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 nameEvolocumab
    D.3.2Product code AMG 145
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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 INNEvolocumab
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeAMG145
    D.3.9.3Other descriptive nameAMG145
    D.3.9.4EV Substance CodeSUB32500
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 Yes
    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 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 nameEvolocumab
    D.3.2Product code AMG 145
    D.3.4Pharmaceutical form Solution for injection in cartridge
    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 INNEvolocumab
    D.3.9.2Current sponsor codeAMG145
    D.3.9.3Other descriptive nameAMG145
    D.3.9.4EV Substance CodeSUB32500
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 Yes
    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 in pre-filled pen
    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 placeboSolution for injection in cartridge
    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
    Coronary Artery Disease
    E.1.1.1Medical condition in easily understood language
    Plaque build up in the heart's arteries in patients with increased cholesterol in the blood
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10011079
    E.1.2Term Coronary artery disease NOS
    E.1.2System Organ Class 100000004849
    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 effect of AMG 145 on the change in burden of coronary atherosclerosis as measured by percent atheroma volume (PAV) in patients with coronary artery disease requiring angiography for a clinical indication who are taking statins.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of AMG 145 on the change in normalized total atheroma volume (TAV) and the percentage of patients who demonstrate regression of coronary atherosclerosis either by PAV or TAV.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    All subjects will be invited to consent to pharmacogenetic analyses. The goals of the optional studies include the use of genetic markers to help in the investigation of cardiovascular disease, hyperlipidemia and other metabolic disorders and/or to identify subjects who may have positive or negative response to AMG 145. No additional blood will be collected for the pharmacogenetic analyses. DNA will be extracted from blood samples already collected.
    E.3Principal inclusion criteria
    - Subject has provided informed consent
    - Male or female ≥ 18 age at screening
    - Clinical indication for coronary angiography
    - Subjects already taking statin therapy, regulatory-approved sustained-release niacin (eg Niaspancurrently taking lipid-regulating therapy can be screened but must enter the study via a lipid stabilization period.
    OR
    - Subjects who are intolerant to statins (limited to no more than approximately 10% of total planned enrollment) must meet statin intolerance entry criteria in Appendix G.
    - Subjects must have at least one eligible LDL-C level (as defined below) via local, central laboratory or point of care device at the initial screening visit and, if applicable, at the end of each lipid stabilization period. A pre-existing local LDL-C level may be used as the initial screening LDL-C value as long as it was drawn within 4 weeks of the screening visit and no interim changes to lipid regulating therapy have occurred during that 4 week period.
    LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors
    OR
    LDL-C ≥ 60 -<80 mg/dL (1.55-2.07 mmol/L) in the presence of one Major or three Minor Risk factors as defined in the study protocol. Enrollment of subjects with LDL-C between ≥ 60 mg/dL (1.55 mmol/L) and < 80 mg/dL (2.07 mmol/L) will be limited to no more than approximately 25% of total planned enrollment.
    (For all major and minor risk factors, please see protocol)
    E.4Principal exclusion criteria
    - Clinically significant heart disease which in the opinion of the Principal Investigator is likely to require coronary bypass surgery, PCI (does not apply to PCI deemed necessary by the initial screening angiogram), cardiac transplantation, surgical or percutaneous valve repair and/or replacement during the course of the study.
    - Coronary artery bypass graft surgery < 6 weeks prior to the qualifying IVUS.
    - NYHA III or IV heart failure, or last known left ventricular ejection fraction < 30%
    - Uncontrolled cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 3 months prior to randomization
    - Known hemorrhagic stroke
    - Uncontrolled hypertension at Randomization visit, defined as a resting systolic blood pressure of ≥ 180mmHg.
    - Personal or family history of hereditary muscular disorders
    - Fasting triglycerides ≥ 400 mg/dL (4.5 mmol/L) at screening and at end of lipid stabilization period
    - Subject has taken a cholesterol ester transfer protein (CETP) inhibitor, (ie. anacetrapib, dalcetrapib, evacetrapib) or mipomersen or lomitapide in the last 12 months prior to LDL-C screening.
    - Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c > 9%) at screening.
    - Treatment for more than 2 weeks in the last 3 months prior to LDL-C screening with any of the following drugs: systemic cyclosporine, systemic steroids (eg. IV, intramuscular [IM], or PO) ) (Note: hormone replacement therapy is permitted); systemic vitamin A and retinol
    derivatives for the treatment of dermatologic conditions (eg, Accutane) (Note: vitamin A in topical and multivitamin preparations
    are permitted)
    - Thyroid stimulating hormone (TSH) < lower limit of normal (LLN) or TSH > 1.5x upper limit of normal (ULN). A subject taking thyroid replacement therapy may be enrolled with TSH level below LLN if, in
    the opinion of the investigator, the subject is in a clinically euthyroid state.
    - Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 at screening, confirmed by a repeat measurement at least 1 week apart
    - Active liver disease or hepatic dysfunction, defined as aspartate
    aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the ULN as determined by analysis at screening or at end of lipid stabilization period.
    - CK > 3 times the ULN at screening or at end of lipid stabilization period
    - Known active infection or major hematologic, renal, metabolic,
    gastrointestinal or endocrine dysfunction in the judgment of the
    investigator
    - Baseline IVUS does not meet IVUS Core Lab technical standards
    - Unreliability as a study participant based on the investigator's (or
    designee’s) knowledge of the subject (eg, alcohol or other drug abuse, inability or unwillingness to adhere to the protocol, or psychosis)
    - Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
    - Female subject who has not used an acceptable method(s) of birth control for at least 1 month prior to screening, unless the female subject is sterilized or postmenopausal (see protocol)
    - Female subject is not willing to inform her partner of her participation in this clinical study and to use an acceptable method(s) of birth control during treatment with IP (AMG 145 or placebo) and for an additional 15 weeks after the end of treatment with IP (AMG 145 or placebo)unless the female subject is sterilized or postmenopausal (see protocol).
    - Subject is pregnant or breast feeding, planning to become pregnant, or planning to breastfeed during the screening period, at the end of the lipid stabilization period (if applicable), while receiving treatment with IP (AMG 145 or placebo) and within 15 weeks after the end of treatment with IP (AMG 145 or placebo)
    - History of malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma)
    - Subject has previously received AMG 145 or any other investigational therapy to inhibit PCSK9
    - Known sensitivity to any of the active substances or their excipients (eg. carboxymethylcellulose) to be administered during the study
    - Subject will not be available for protocol-required study visits or procedures, to the best of the subject and investigator’s knowledge.
    - Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    The nominal change in percent atheroma volume (PAV) from baseline to 78 weeks post randomization
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and week 78
    E.5.2Secondary end point(s)
    • Nominal change in total atheroma volume (TAV) from baseline to week 78
    • Regression (any reduction from baseline) in PAV
    • Regression (any reduction from baseline) in TAV
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and week 78 for all secondary endpoints
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 trial2
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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
    Argentina
    Australia
    Belgium
    Canada
    Chile
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Russian Federation
    South Africa
    Spain
    Sweden
    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
    LSLV
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 745
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 225
    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 state145
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 970
    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)
    The plans for treatment or care after the subject has ended participation in the trial are no different from the expected normal treatment for the condition under investigation.
    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 Decision2013-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-29
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