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    Summary
    EudraCT Number:2011-003827-37
    Sponsor's Protocol Code Number:20110109
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-25
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-003827-37
    A.3Full title of the trial
    A Double-blind, Randomized, Placebo-controlled, Multicenter Study to
    Evaluate Long-term Tolerability and Durable Efficacy of AMG 145 on LDL-C in Hyperlipidemic Subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the tolerability and durable effect of AMG 145 in patients with Hyperlipidemia
    A.3.2Name or abbreviated title of the trial where available
    DESCARTES, Durable Effect of PCSK9 antibody CompARed wiTh placEbo Study
    A.4.1Sponsor's protocol code number20110109
    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 supportAmgen 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 nameAMG 145
    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.3.9.2Current sponsor codeAMG 145
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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
    Hyperlipidemia
    E.1.1.1Medical condition in easily understood language
    Abnormal amounts of lipids in the blood and Elevated level of total
    cholesterol in the bloodstream
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10020667
    E.1.2Term Hyperlipidemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of 52 weeks of subcutaneous (SC) AMG 145 every 4 weeks (Q4W), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) when added to background lipid-lowering therapy
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of SC AMG 145, given for 52
    weeks compared to placebo in subjects with hyperlipidemia on
    background lipid lowering therapy
    • To assess the effects of 52 weeks of SC AMG 145 compared to placebo
    on change from baseline in LDL-C, and percent change from baseline in
    non-high density lipoprotein cholesterol (non-HDL-C), apolipoprotein B
    (ApoB), total cholesterol/HDL-C ratio, and ApoB/Apolipoprotein A-1
    (ApoA1) ratio, Lipoprotein (a) [Lp(a)], triglycerides and HDL-C in
    subjects with hyperlipidemia on background lipid lowering therapy
    • To evaluate the consistency of the long term treatment effect of SC
    AMG 145 compared to placebo in subjects with hyperlipidemia on
    background lipid-lowering therapy
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Vitamin E substudy
    Approximately 100 subjects (50 subjects per treatment arm, including subjects receiving placebo) will be selected to participate in the Vitamin E (serum Vit E, LDL-Vit E, HDL-Vit E, RBC-Vit E, and non-HDL-Vit E) substudy. The sub study will provide additional data about how AMG145 affects Vitamin E levels. Subjects in the Vitamin E substudy will provide additional blood samples at Day 1, week 12, and week 52.
    E.3Principal inclusion criteria
    - Subject has provided informed consent.
    - Male or female ≥ 18 to ≤ 75 years of age at screening.
    - Fasting LDL-C ≥ 75 mg/dL as determined by central laboratory at the initial screening visit
    - Fasting LDL-C as determined by central laboratory at the end of the lipid stabilization period ≥ 75 mg/dL (2.0 mmol/L) and meeting the following LDL-C values based on risk factor status (NCEP ATPIII risk categories Grundy et al, 2004):
    • < 100 mg/dL (2.6 mmol/L) for subjects with diagnosed CHD or CHD risk equivalent (includes clinical manifestations of noncoronary forms of atherosclerotic disease [peripheral arterial disease, abdominal aortic aneurysm, and carotid artery disease], diabetes, and 2+ risk factors with 10-year risk for hard CHD >20%). Risk factors include cigarette smoking, hypertension (BP ≥ 140/90 mm Hg or on antihypertensive medication), low HDL cholesterol (< 40 mg/dL), family history of premature CHD (CHD in male first-degree relative < 55 years of age; CHD in female first-degree relative < 65 years of age), and age (men ≥ 45 years; women ≥ 55 years).
    • < 130 mg/dL (3.4 mmol/L) for subjects without diagnosed CHD or CHD risk equivalent
    • OR for subjects on maximal background lipid-lowering therapy (defined as atorvastatin 80 mg PO QD and ezetimibe 10 mg PO QD), LDL-C at the end of the lipid stabilization period of ≥75 mg/dL (2.0 mmol/L)
    - Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) by central laboratory at screening and at end of lipid stabilization period
    E.4Principal exclusion criteria
    - Diagnosed with CHD or CHD risk equivalent and not receiving statin therapy, with LDL-C at screening ≤ 99 mg/dL
    - NYHA II, 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
    - Myocardial infarction, unstable angina, percutaneous coronary
    intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
    - Planned cardiac surgery or revascularization
    - Type 1 diabetes or newly diagnosed type 2 diabetes (within 6 months of randomization or new screening fasting plasma glucose ≥ 126 mg/dL [7.0 mmol/L] or HbA1c ≥ 6.5%), or
    - Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg, confirmed with repeat measurement
    - Subject has taken in the last 6 weeks prior to LDL-C screening red yeast rice, > 200 mg/day niacin, or >1000 mg/day omega-3 fatty acids (eg, DHA and EPA) or prescription lipid-regulating drugs other than statins or ezetimibe, such as fibrates and derivatives, or bile-acid sequestering resins
    -Treatment 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), vitamin A derivatives and retinol derivatives for the
    treatment of dermatologic conditions (eg, Accutane); (Note: vitamin A in
    a multivitamin preparation is permitted) Hyperthyroidism or
    hypothyroidism as defined by thyroid stimulating hormone TSH below
    the lower limit of normal (LLN) or > 1.5 times the upper limit of normal
    (ULN), respectively, at screening
    - 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 central laboratory analysis at screening or at end of lipid stabilization period, confirmed by a CK > 3 times the ULN at screening or at end of lipid stabilization period, confirmed by a repeat measurement at least 1 week apart
    - Known active infection or major hematologic, renal, metabolic,
    gastrointestinal or endocrine dysfunction in the judgment of the
    investigator
    - Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months prior to randomization
    - Current therapeutic anticoagulation with vitamin K antagonist (eg, warfarin), heparin, low-molecular weight heparin, direct thrombin inhibitor, or Factor Xa inhibitor. (Note: anti-platelet agents [eg, aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamole] are permitted).
    - 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 is not willing to use at least 1 highly effective method of birth control during treatment and for an additional 15 weeks after the end of treatment unless subject is sterilized or postmenopausal;
    - 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‖
    - Highly effective methods of birth control include abstinence, birth control pills, shots, implants, or patches, intrauterine devices (IUDs), 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 during treatment and/or within 15 weeks after the end of treatment 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 products to be administered during dosing.
    For additional exclusion criteria refer to protocol section 4.2.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change from baseline in LDL-C at week 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 52
    E.5.2Secondary end point(s)
    Secondary Endpoints (Hypothesis Testing)
    Tier 1
    • Change from baseline in LDL-C at week 52
    • LDL-C response (LDL-C < 70 mg/dL [1.8 mmol/L]) at week 52
    • Percent change from baseline in LDL-C at week 12
    • Percent change from baseline in non-HDL-C at week 52
    • Percent change from baseline in ApoB at week 52
    • Percent change from baseline in the total cholesterol/HDL-C ratio at
    week 52
    • Percent change from baseline in ApoB/ApoA1 ratio at week 52
    Tier 2
    • Percent change from baseline in Lp(a) at week 52
    • Percent change from baseline in triglycerides at week 52
    • Percent change from baseline in HDL-C at week 52
    Secondary Endpoint (Estimation)
    • Percent change from week 12 in LDL-C at week 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Endpoints (Hypothesis Testing)
    Tier 1
    • Change from baseline in LDL-C at week 52
    • LDL-C response (LDL-C < 70 mg/dL [1.8 mmol/L]) at week 52
    • Percent change from baseline in LDL-C at week 12
    • Percent change from baseline in non-HDL-C at week 52
    • Percent change from baseline in ApoB at week 52
    • Percent change from baseline in the total cholesterol/HDL-C ratio at
    week 52
    • Percent change from baseline in ApoB/ApoA1 ratio at week 52
    Tier 2
    • Percent change from baseline in Lp(a) at week 52
    • Percent change from baseline in triglycerides at week 52
    • Percent change from baseline in HDL-C at week 52
    Secondary Endpoint (Estimation)
    • Percent change from week 12 in LDL-C at week 52
    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 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 Yes
    E.6.13.1Other scope of the trial description
    biomarker development
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    South Africa
    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
    The end of the study for this trial is defined as the date on which the last randomized subject has had the opportunity to complete their week 52 assessment. The primary completion date is the date that the last randomized subject completes the week 52 assessment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months20
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months20
    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: 540
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 360
    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 No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 900
    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 not different from the expected normal treatment of this condition
    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 Decision2012-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-14
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