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    Summary
    EudraCT Number:2017-004129-33
    Sponsor's Protocol Code Number:CRC2017EVO
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-05-07
    Trial 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 ConcernedGermany - PEI
    A.2EudraCT number2017-004129-33
    A.3Full title of the trial
    Randomized, double-blind, placebo controlled, parallel-group, prospective clinical study to analyse the effect of evolocumab on vascular function.
    Randomisierte, doppel-blinde, Plazebo kontrollierte, prospektive klinische Studie zur Analyse des Effektes von Evolocumab auf die vaskuläre Funktion
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinically study with randomly into groups divided patients to determine the effects of evolocumab compared to placebo on vascular function.
    Klinische Studie mit nach dem Zufallsprinzip in Gruppen eingeteilte Patienten, um die Auswirkungen von Evolocumab verglichen mit Plazebo auf die vaskuläre Funktion zu erforschen.
    A.4.1Sponsor's protocol code numberCRC2017EVO
    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 SponsorFriedrich-Alexander-Universtiy Erlangen-Nürnberg, Medical Faculty
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAMGEN GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Klinik 4, Friedrich-Alexander University Erlangen-Nürnberg
    B.5.2Functional name of contact pointClinical Resarch Unit
    B.5.3 Address:
    B.5.3.1Street AddressUlmenweg 18
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.4Telephone number004991318536245
    B.5.5Fax number004991318536215
    B.5.6E-mailroland.schmieder@uk-erlangen.de
    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 Yes
    D.2.1.1.1Trade name Repatha
    D.2.1.1.2Name of the Marketing Authorisation holderAMGEN GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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.3.9.3Other descriptive nameEvolocumab
    D.3.9.4EV Substance CodeSUB128552
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 placeboSolution for injection in pre-filled pen
    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
    atherosclerotic cardiovascular disease
    atherosklerotische kardiovaskuläre Erkrankung
    E.1.1.1Medical condition in easily understood language
    atherosclerotic cardiovascular disease
    atherosklerotische kardiovaskuläre Erkrankung
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051615
    E.1.2Term Atherosclerotic cardiovascular disease
    E.1.2System Organ Class 100000004866
    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 subcutaneous (SC) evolocumab compared with placebo on
    - absolute and percent change of FMD (UNEX EF) after 8 weeks of treatment from baseline.
    Effekt von Evolocumab (subkutan) verglichen mit Plazebo auf
    - die absolute und prozentuale Änderung der Fluß-vermittelten Vasodilatation (FMD) (UNEX EF) nach 8 Wochen Therapie
    E.2.2Secondary objectives of the trial
    To evaluate the effect of SC evolocumab compared with placebo on
    - absolute and percent change of FMD (UNEX EF) after 1 and 4 weeks of treatment from baseline and and across all visits.
    - absolute and percent change of L-FMC and combined FMD+L-FMC (UNEX EF) after 1, 4 and 8 weeks of treatment from baseline and across all visits.
    - absolute and percent change of pSBP, pDBP (Dinamap ), cSBP, cDBP, cPP, cAP, Pf, Pb, cAIx(@75) and PWV assessed on-site (Sphygmocor™) after 1, 4 and 8 weeks of treatment from baseline and across all visits.
    - absolute and percent change of pSBP, pDBP, cSBP, cDBP, cPP, cAP, Pf, Pb, cAIx(@75) and PWV assessed over 24 hours (Mobil-O-Graph®) after 1, 4 and 8 weeks of treatment from baseline and across all visits.
    - absolute and percent change of LDL-C, Lp(a), non HDL-C, and triglycerides after 1, 4 and 8 weeks of treatment from baseline and across all visits.
    Effekt von Evolocumab (subkutan) verglichen mit Plazebo auf
    - die absolute und prozentuale Änderung der FMD (UNEX EF) nach 1 und 4 Wochen Therapie sowie über alle Visiten
    - die absolute und prozentuale Änderung der niedrig Fluß-vermittelten Vasokonstriktion (L-FMC) und der kombinierten FMD und L-FMC (UNEX EF) nach 1, 4 und 8 Wochen Therapie, sowie über alle Visiten
    - die absolute und prozentuale Änderung des pSBP, pDBP (Dinamap), cSBP, cDBP, cPP, cAP, Pf, Pb, cAIx(@75) und der PWV vor Ort erhoben (Sphygmocor™) nach 1, 4 und 8 Wochen Therapie, sowie über alle Visiten
    - die absolute und prozentuale Änderung des pSBP, pDBP, cSBP, cDBP, cPP, cAP, Pf, Pb, cAIx(@75) und der PWV über 24-h ambulant erhoben (Mobil-O-Graph®) nach 1, 4 und 8 Wochen Therapie, sowie über alle Visiten
    - die absolute und prozentuale Änderung des LDL-Cholesterins, Lipopotein(a), nicht-HDL-Cholesterin und der Triglyzeride nach 1, 4 und 8 Wochen Therapie, sowie über alle Visiten
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed informed consent in written form
    - Male or female 40 - 80 years
    - History of clinically evident atherosclerotic cardiovascular disease as evidenced by ANY of the following:
    o diagnosis of coronary artery disease as evidenced by acute coronary syndrome, myocardial infarction, coronary stent implantation, coronary stenosis ≥ 50% by coronary angiography.
    o diagnosis of non-hemorrhagic stroke or transient ischemic attack (TIA)
    o symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) < 0.85, or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease, or artery stenosis ≥ 50% by angiography
    - Fasting LDL-C ≥ 70 mg/dL (≥ 1.8 mmol/L) or non-HDL-C ≥ 100 mg/dL (≥ 2.6mmol/L) on optimized background lipid lowering therapy (please see Appendix 14.3., study protocol version 1.6)
    - stable background lipid lowering therapy for at least 4 weeks (please see Appendix 14.3, study protocol, version 1.6)
    - Most recent fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) by central laboratory before randomization
    - Unterzeichnete schriftliche Einverständniserklärung
    - Männer und Frauen im Alter von 40 – 80 Jahren
    - Bekannte klinische offensichtliche atherosklerotische kardiovaskuläre Erkrankung nachgewiesen durch EINES der folgenden
    o Diagnose einer koronaren Herzerkrankung nachgewiesen durch akutes Koronarsyndrom, Myokardinfarkt, koronare Stentimplantation, koronare Stenose ≥ 50% in der koronaren Angiographie
    o Diagnose eines nicht-hämorrhagischen Schlaganfalls oder transienter ischämischer Attacke (TIA)
    o Symptomatische periphere arterielle Verschlußkrankheit (PAD), nachgewiesen durch intermittierende Claudicatio mit einem Knöchel-Arm Index (ABI) <0.85, oder peripherer arterieller Revasularisierung, oder Amputation wegen einer atherosklerotischen Erkrankung, oder arteriellen Stenose ≥ 50% in der Angiographie
    - Nüchtern LDL-Cholesterin ≥ 70 mg/dL (≥ 1.8 mmol/L) oder nicht-HDL-Cholesterin ≥ 100 mg/dL (≥ 2.6mmol/L) trotz einer optimierten lipidsenkenden Therapie
    - Stabile lipidsenkende Therapie über mindestens 4 Wochen
    - Neueste Nüchtern-Triglyzeride ≤ 400 mg/dL (4.5 mmol/L) im Zentrallabor vor Randomisierung
    E.4Principal exclusion criteria
    - Inability to image the brachial artery and to perform FMD
    - Subjects with statin intolerance
    - Known or suspected homozygous FH
    - Subject must not be randomized within 4 weeks of their most recent MI or stroke
    - NYHA class III or IV, or last known left ventricular ejection fraction < 30%
    - Atrial fibrillation
    - Known hemorrhagic stroke at any time
    - Uncontrolled or recurrent ventricular tachycardia
    - Planned or expected cardiac surgery or revascularization within 3 months after randomization
    - Uncontrolled hypertension defined as sitting pSBP > 180 mmHg or pDBP > 110 mmHg
    - Use of cholesteryl ester transfer protein (CETP) inhibition treatment, mipomersen, or lomitapide within 12 months prior to randomization. Fenofibrate therapy must be stable for at least 6 weeks prior to final screening at a dose that is appropriate for the duration of the study in the judgment of the investigator. Other fibrate therapy (and derivatives) are prohibited
    - Prior use of PCSK9 inhibition treatment other than evolocumab or use of evolocumab < 12 weeks prior to final lipid screening
    - Untreated or inadequately treated hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) < lower limit of normal (LLN) or > 1.5 times the upper limit of normal (ULN), respectively, and free thyroxine (T4) levels that are outside normal range at final screening
    - Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 at final screening
    - Active liver disease or hepatic dysfunction, defined as serum Glutamate-Oxaloacetate-Transaminase (SGOT) or serum Glutamate-Pyruvate-Transaminase (SGPT) > 3 times the ULN as determined by central laboratory analysis at final screening
    - Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal)
    - Personal or family history of hereditary muscular disorders
    - LDL or plasma apheresis within 12 months prior to randomization
    - Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years
    - Creatinine Kinase (CK) > 5 times the ULN at final screening
    - Known major active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator
    - Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 10 years
    - Subject has received drugs via a systemic route that have known major interactions with background statin therapy (see Appendix 14.4., study protocol version 1.6) within 1 month prior to randomization or is likely to require such treatment during the study period
    - Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or less than 5 fold of half-live time of the investigational drug, or receiving other investigational agent(s)
    - Female subject who has either (1) not used acceptable method(s) of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment with IP and for an additional 15 weeks after the end of treatment with IP, unless the subject is sterilized or postmenopausal;
    o menopause is defined as 12 months of spontaneous and continuous amenorrhea in a female ≥ 55 years old or 12 months of spontaneous and continuous amenorrhea with a follicle-stimulating hormone (FSH) level > 40 IU/L (or according to the definition of "postmenopausal range" for the laboratory involved) in a female < 55 years old unless the subject has undergone bilateral oophorectomy
    o acceptable methods of preventing pregnancy include not having intercourse, birth control pills, injections, implants, or patches, intrauterine devices (IUDs), tubal ligation/occlusion, sexual activity with a male partner who has had a vasectomy, condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide
    - Subject is pregnant or breast feeding, or planning to become pregnant or to breastfeed during treatment with IP and/ or within 15 weeks after the end of treatment with IP
    - Known sensitivity to any of the active substances or their excipients to be administered during dosing
    - Subject likely to not be available to complete all protocol-required study visits or procedures, to the best of the subject’s and investigator’s knowledge
    - Unfähigkeit zur Visualisierung der Brachialarterie und somit die FMD durchzuführen
    - Patienten mit Statinunverträglichkeit
    - Bekannte oder vermutete homozygote familiäre Hypercholesterinämie
    - Patienten dürfen nicht innerhalb 4 Wochen nach dem letzten MI oder Apoplex randomisiert werden
    - NYHA-Klasse III oder IV, oder letzte bekannte linksventrikuläre Auswurffraktion < 30%
    - Vorhofflimmern
    - Bekannter hämorrhagischer Schlaganfall
    - Unkontrollierte oder rekurrente ventrikuläre Tachykardie
    - Geplante oder zu erwartende Herzoperation oder Revaskularisierung innerhalb 3 Monate nach Randomisierung
    - Unkontrollierte Hypertonie, definiert durch einen pSBP > 180 mmHg or pDBP > 110 mmHg im Sitzen
    - Therapie mit Cholesterinester-Transferprotein-Hemmer, Mimpomersen, oder Lomitapid innerhalb der letzten 12 Monate vor Randomisierung; stabile Fenofibrattherapie für mindestens 6 Wochen vor einem finalen Screening in einer angemessenen Dosis, anhand der Bewertung des Investigators, für die Dauer der Studie; andere Fibrate (und Derivate) sind nicht erlaubt
    - Vorherige Therapie mit einem anderen PCSK9-Hemmer als Evolocumab oder die Therapie mit Evolocumab < 12 Wochen vor dem finalen Lipid-Screening
    - Unbehandelte oder inadäquat-behandelnde Hyperthyreose oder Hypothyreose, definiert als Thyreoidea-stimulierendes Hormon (TSH) < der unteren Grenze des Normalbereichs oder 1.5-fach über der oberen Grenze des Normalbereichs, und freies Thyroxin (T4) außerhalb des Normalbereichs beim finalen Screening
    - Schwere renale Dysfunktion, definiert als geschätzte glomeruläre Filtrationsrate (eGFR) < 30 mL/min/1.73m2 beim finalen Screening
    - Akute Lebererkrankung oder hepatische Dysfunktion, definiert als Serum Glutamate-Oxaloacetate-Transaminase (SGOT) oder Serum Glutamate-Pyruvate-Transaminase (SGPT) > 3-fach des oberen Normalbereichs im Zentrallabor beim finalen Screening
    - Organtransplantation (z.B. Lunge, Leber, Herz, Knochenmark, Niere)
    - Eigene oder familiär bekannte heriditäre Muskelstörung
    - LDL oder Plasmapherese innerhalb der letzten 12 Monate vor Randomisierung
    - Schwere, begleitende nicht-kardiovaskuläre Erkrankung die mit einer Lebenserwartung kleiner 3 Jahre einhergeht
    - Kreatinin-Kinase (CK) > 5-fach über den oberen Normalbereich beim finalen Screening
    - Bekannte bedeutende aktive Infektion oder bedeutende hämatologische, renale, metabolische, gastrointestinale oder endokrinologische Dysfunktion gemäß der Bewertung des Investigators
    - Malignom (mit Ausnahme eines weißen Hautkrebs, Zervixtumor in situ, duktales Mammakarzinom in situ oder Prostatatumor Stadium 1) innerhalb der letzten 10 Jahre
    - Systemische Verabreichung von Medikamenten, die eine bedeutende Interaktion mit der Begleit-lipidsenkenden Therapie haben, innerhalb eines Monates vor Randomisierung oder gegebene Wahrscheinlichkeit das eine solche Therapie während der Studie notwending ist
    - Teilnahme an einer anderen Geräte- oder Medikamentenstudie, oder < 30 Tage nach Beendigung der Teilnahme an einer anderen Geräte- oder Medikamentenstudie, oder kleiner als der 5-fachen Halbwertszeit eines zu untersuchenden Medikamentes, oder Einnahme eines anderen zu untersuchenden Stoffes
    - Frauen, die (1) nicht eine geeignete Methode zur Schwangerschaftsverhütung mindestens einen Monat vor Screening oder (2) nicht bereit sind eine solche Methode während der Studie und für weitere 15 Wochen nach Beendigung der Studie wahrzunehmen, es sei den das die Frau sterilisert oder in der Postmenopause ist
    o Menopause ist definiert als 12 Monate einer spontanen und andauernden Ammenorrhoe bei Frauen ≥ 55 Jahren oder 12 Monate einer spontanen und andauernden Ammenorrhoe mit einem Follikel-stimulierenden Hormon > 40 IU/L (oder anhand des Wertes für die Definition des postmenopausalen Bereiches des entsprechenden Labors) bei Frauen < 55 Jahren, es sei denn die Frau hat sich einer bilateralen Ovarektomie unterzogen
    o Geeignete Methoden zur Schwangerschaftsverhütung umfassen Abstinenz, Pille, Injektion, Implantat oder Pflaster zur Schwangerschaftsverhütung, intrauterine Methoden, Tubenligatur/Okklusion, sexuelle Aktivität mit einem männlichen Partner der sich einer Vasektomie unterzogen hat, Kondom, oder ein Diaghragma oder Portiokappe mit Spermizid
    - Schwangere oder stillende Frauen, oder die planen schwanger oder stillend während der Studie oder innerhalb 15 Wochen nach dessen Beendigung zu werden
    - Bekannte Sensitivität für eine aktive Substanz oder ihrer Hilfsstoffe, die während der Studie gegeben werden
    - Personen die wahrscheinlich nicht alle notwendigen Visiten oder Prozeduren die durch das Protokoll festgelegt sind, einhalten (können), anhand der Einschätzung der Person selbst oder aber des Investigator
    E.5 End points
    E.5.1Primary end point(s)
    Effect of subcutaneous (SC) evolocumab compared with placebo on
    - absolute and percent change of FMD (UNEX EF) after 8 weeks of treatment from baseline.
    Effekt von Evolocumab (subkutan) verglichen mit Plazebo auf
    - die absolute und prozentuale Änderung der Fluß-vermittelten Vasodilatation (FMD) (UNEX EF) nach 8 Wochen Therapie
    E.5.1.1Timepoint(s) of evaluation of this end point
    before and after 8 weeks of treatment (parallel-arm study)
    vor und nach 8 Wochen der Behandlungsphase (parallel-Arm Studie)
    E.5.2Secondary end point(s)
    Effect of SC evolocumab compared with placebo on
    - absolute and percent change of FMD (UNEX EF) after 1 and 4 weeks of treatment from baseline and and across all visits.
    - absolute and percent change of L-FMC and combined FMD+L-FMC (UNEX EF) after 1, 4 and 8 weeks of treatment from baseline and across all visits.
    - absolute and percent change of peripheral systolic BP (pSBP), peripheral diastolic BP (pDBP) (Dinamap ), cSBP, central diastolic BP (cDBP), central pulse pressure (cPP), central augmentation pressure (cAP), forward pressure amplitude (Pf), backward pressure amplitude (Pb), central augmentation index (cAIx, also normalized to a heart rate of 75 beats per minute [cAIx@75]) and PWV assessed on-site (Sphygmocor™) after 1, 4 and 8 weeks of treatment from baseline and across all visits.
    - absolute and percent change of pSBP, pDBP, cSBP, cDBP, cPP, cAP, Pf, Pb, cAIx(@75) and PWV assessed over 24 hours (Mobil-O-Graph®) after 1, 4 and 8 weeks of treatment from baseline and across all visits.
    - absolute and percent change of LDL-C, lipoprotein(a) [Lp(a)], non-high-density lipoprotein cholesterol (non HDL-C), and triglycerides after 1, 4 and 8 weeks of treatment from baseline and across all visits.
    Effekt von Evolocumab (subkutan) verglichen mit Plazebo auf
    - die absolute und prozentuale Änderung der FMD (UNEX EF) nach 1 und 4 Wochen Therapie sowie über alle Visiten
    - die absolute und prozentuale Änderung der niedrig Fluß-vermittelten Vasokonstriktion (L-FMC) und der kombinierten FMD und L-FMC (UNEX EF) nach 1, 4 und 8 Wochen Therapie, sowie über alle Visiten
    - die absolute und prozentuale Änderung des peripheren systolischen Blutdrucks (pS[BP]), peripheren diastolischen BP (pDBP) (Dinamap), zentralen systolischen BP (cSBP), zentralen diastolischen BP (cDBP), zentralen Pulsdruck (cPP), zentralen Augmentationsdruck (cAP), Forwärtsdruckamplitude (Pf), Rückwärtsdruckamplitude (Pb), zentralen Augmentationsindex (cAIx, ebenso auf eine Herzfrequenz von 75 Schlägen pro Minute normalisiert [cAIx@75]) und der Pulswellengeschindigkeit (PWV) vor Ort erhoben (Sphygmocor™) nach 1, 4 und 8 Wochen Therapie, sowie über alle Visiten
    - die absolute und prozentuale Änderung des pSBP, pDBP, cSBP, cDBP, cPP, cAP, Pf, Pb, cAIx(@75) und der PWV über 24-h ambulant erhoben (Mobil-O-Graph®) nach 1, 4 und 8 Wochen Therapie, sowie über alle Visiten
    - die absolute und prozentuale Änderung des LDL-Cholesterins, Lipopotein(a), nicht-HDL-Cholesterin und der Triglyzeride nach 1, 4 und 8 Wochen Therapie, sowie über alle Visiten
    E.5.2.1Timepoint(s) of evaluation of this end point
    before and after 1, 4 and 8 weeks of treatment (parallel-arm study)
    vor und nach 1, 4 und 8 Wochen der Behandlungsphase (paralel-arm Studie)
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    letzte Visite vom letzten Patienten
    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
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state65
    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)
    After completing the trial the participant will be under the continuous care of his/her family physician. This will be explained to the study participant and the family physician will be informed by a letter written by the investigator after the last study visit once the lab data have been received of each study participant.
    Nach Abschluß der Studie wird der Teilnehmer unter der Obhut des (Haus-) Arztes stehen. Dies wird dem Teilnehmer ausführlich erklärt und der (Haus-) Arzt wird durch einen Brief der Prüfer nach dem letzten Studienbesuch (nach Erhalt der Laborwerte) verfasst, informiert.
    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 Decision2018-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-07
    P. End of Trial
    P.End of Trial StatusOngoing
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