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    Summary
    EudraCT Number:2015-002322-40
    Sponsor's Protocol Code Number:20140254
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-24
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2015-002322-40
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of AMG 334 on Exercise Time During a Treadmill Test in Subjects With Stable Angina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating how AMG 344 effects the duration that subjects with angina are able to run on a treadmill.
    A.4.1Sponsor's protocol code number20140254
    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, PO Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-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 334
    D.3.2Product code AMG 334
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.1CAS number 1582205-90-0
    D.3.9.2Current sponsor codeAMG 334
    D.3.9.3Other descriptive nameAMG 334
    D.3.9.4EV Substance CodeSUB74690
    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 placeboInjection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Migraine Prevention
    E.1.1.1Medical condition in easily understood language
    Prevention of migraine headaches
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10027599
    E.1.2Term Migraine
    E.1.2System Organ Class 10029205 - Nervous system 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 AMG 334 compared to placebo on exercise capacity in subjects with stable angina as measured by total exercise time (TET) during an exercise treadmill test (ETT).
    E.2.2Secondary objectives of the trial
    To evaluate the effect of AMG 334 compared to placebo during an ETT on the time to the onset of:
    • Exercise-induced angina
    • ST-segment depression
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures.

    • Age ≥ 18 to ≤ 85 at the time of screening.

    • History of chronic stable angina for at least 3 months prior to screening, with at least 1 angina episode/month, on average over that period.

    • Ischemic heart disease documented by any one or more of the following:
    a. A history of myocardial infarction (MI) with elevated Creatine kinase - myocardial band (CK-MB), troponin I or T, or the presence of electrocardiogram (ECG) changes consistent with an MI, or
    b. Coronary angiography demonstrating at least 1 major epicardial coronary artery (eg, left anterior descending, left circumflex, or right coronary artery) with a stenosis of at least 50% diameter or greater but excluding > 50% or flow-limiting stenosis of the left main coronary artery unless revascularized by coronary artery bypass grafting, or
    c. Revascularization procedure (eg, cardiac bypass graft, angioplasty) ≥ 3 months prior to screening

    • Receiving stable doses of cardiac medications (eg, beta blockers, calcium channel blockers, antianginals, etc.) for at least 30 days prior to randomization and that are not expected to change during the study

    • Completes 2 consecutive ETTs during screening, performed > 48 hours and ≤ 14 days apart using a standard Bruce ETT protocol, with:
    a. Limitation of exercise due to symptoms of angina or ≥ 3 mm ST-segment depression
    b. ≥ 1.0 mm ischemic ST-segment depression
    c. Exercise duration of ≥ 3 to ≤ 12 minutes , and
    d. ≤ 1 minute difference or within 20% duration (using the longest duration qualifying ETT) in TET between the 2 qualifying tests
    e. ECG tracings from screening ETTs are acceptable to the core ECG laboratory
    E.4Principal exclusion criteria
    General
    • Currently participating in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug studies. Other investigational procedures while participating in this study are not allowed.
    • Current or prior malignancy within 5 years of randomization, with the exception of non-melanoma skin cancers, cervical or breast ductal carcinoma in situ, and adenocarcinoma of the prostate Stage I or IIa (defined as T1, T2a or T2b, N0, M0 with documented serum PSA <20 ng/mL and Gleason score ≤7) per the American Joint Committee on Cancer (AJCC) primary tumor, regional lymph nodes, and distant metastasis system.
    • Subject has known sensitivity to any of the components of the investigational product
    • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or not adequately comply with all required study procedures

    • History or evidence of clinically significant disorder, condition or disease that may pose a risk to subject safety or interfere with the study evaluation, procedures or completion

    Reproductive
    • Females of reproductive potential who are not willing to use acceptable method(s) of effective birth control during treatment with AMG 334 and for an additional 12 weeks after receiving a single dose of AMG 334
    • Acceptable methods of effective contraception include: true sexual abstinence when this is in line with the preferred and usual lifestyle of the subject [periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of the study, and withdrawal are not acceptable methods of contraception], or use of hormonal birth control methods (oral, implantable, injectable, transdermal, intravaginal), intrauterine devices (IUDs), intrauterine hormonal-releasing system (IUS), or two (2) barrier methods (one by each partner and at least one of the barrier methods must include spermicide (unless spermicide is not approved in the country or region) - the male must use a condom and the female must choose either a diaphragm OR cervical cap, OR contraceptive sponge (a male and female condom cannot be used together due to the risk of tearing).
    • Female subjects not of childbearing potential are defined as: Any female who is has had a hysterectomy, OR bilateral salpingectomy, OR bilateral oophorectomy, OR are post-menopausal. Post-menopausal women are those who fit into one of the following categories:
    o Age 55 years with cessation of menses for 12 or more months, OR
    o Age < 55 years but no spontaneous menses for at least 2 years, OR
    o Age < 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), AND with postmenopausal gonadotropin level (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved.
    • Females who are pregnant, planning to become pregnant, or breastfeeding during treatment with AMG 334 and for an additional 12 weeks after receiving a single dose of AMG 334.
    • Subject with a positive pregnancy test at screening

    Psychiatric and Neurologic
    • Within the 6 months prior to or during screening, report of suicidal ideation with intent, with or without a plan, or suicidal behavior as evidenced by a Columbia-Suicide Severity Rating Scale (C-SSRS) > 2 during screening.
    • Any psychiatric or neurologic conditions that may interfere with the conduct of the study.

    Psychosocial
    •History of alcohol abuse or dependence within 12 months prior to study enrollment, or inability to refrain from alcohol use within 8 hours prior to ascheduled ETT.
    • Inability to refrain from use of caffeine or nicotine products within 2 hours prior to a scheduled ETT.
    • Unable to refrain from unaccustomed strenuous physical activity from the date of consent through their completion of the trial.

    Cardiovascular
    • History of cardiovascular conditions that may interfere with the conduct or interpretation of the study or may constitute a safety risk per the investigator
    • Systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 90 mmHg (determined by the mean of 3 consecutive measurements at least 5 minutes apart during screening)
    • Within the 3 months prior to or during screening
    a. Unstable angina or acute coronary syndrome
    b. Transient ischemic attack (TIA) or stroke
    c. Revascularization procedure
    d. Instability in ST-segment depression between screening ETTs, as assessed by the core ECG laboratory.
    • ECG findings that preclude analysis of the ETT, including but not limited to:
    a. Left bundle branch block
    b. Pacemaker
    c. Resting ST-segment depression ≥ 1.0 mm
    d. Left ventricular hypertrophy with repolarization changes
    e. Wolf-Parkinson White
    • Digitalis or Implantable defibrillator use
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in TET
    E.5.1.1Timepoint(s) of evaluation of this end point
    The ETT will be conducted in visits 2, 3 and 4 during the screening period, and after randomization and administration of study drug on Day 1.
    E.5.2Secondary end point(s)
    • During the ETT
    o Time to onset of exercise-induced angina
    o Time to onset of ≥ 1 mm ST-segment depression
    E.5.2.1Timepoint(s) of evaluation of this end point
    The ETT will be conducted in visits 2, 3 and 4 during the screening period, and after randomization and administration of study drug on Day 1.
    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 No
    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) 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Czech Republic
    Latvia
    New Zealand
    Poland
    Romania
    Slovakia
    South Africa
    Switzerland
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 54
    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)
    None
    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 Decision2016-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-13
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