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    Summary
    EudraCT Number:2010-021003-24
    Sponsor's Protocol Code Number:20100754
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-04-04
    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 ConcernedFinland - Fimea
    A.2EudraCT number2010-021003-24
    A.3Full title of the trial
    A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure
    A.4.1Sponsor's protocol code number20100754
    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 Information - Clinical
    B.5.3 Address:
    B.5.3.1Street Address240 Cambridge Science Park, Milton Road
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB4 0WD
    B.5.3.4CountryUnited Kingdom
    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 nameomecamtiv mecarbil
    D.3.2Product code AMG423
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNomecamtiv mecarbil
    D.3.9.2Current sponsor codeAMG423
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboConcentrate for solution for infusion
    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
    Acute heart failure
    E.1.1.1Medical condition in easily understood language
    Heart Failure
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10000803
    E.1.2Term Acute heart failure
    E.1.2System Organ Class 10007541 - Cardiac 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 evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure (AHF).
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of 3 dose levels of IV omecamtiv mecarbil compared with placebo in subjects with left ventricular systolic dysfunction hospitalized for AHF.
    To evaluate the effects of 48 hours treatment with IV omecamtiv mecarbil on additional measures of dyspnea, patient global assessment (PGA), change in N-terminal pro brain-type natriuretic peptide (NT-pro BNP) and short-term clinical outcomes.
    To characterize pharmacokinetics of omecamtiv mecarbil, including metabolites M1 and M3, following IV infusion and to evaluate the relationship between omecamtiv mecarbil plasma concentration and echocardiographic parameters in subjects with acute heart failure.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Two substudies are described within the 20100754 protocol, Amendment 1, dated 24-Jan-2011:

    (1) All subjects will be invited to participate in a biomarker and pharmacogenetic substudy. The objectives are:
    To investigate the effects of genetic variation in liver enzymes on omecamtiv mecarbil and metabolite plasma concentrations and/or subject response
    To investigate potential biomarker development by biochemical analysis of blood and urine samples

    (2) At a number of sites, subjects will be invited to participate in a PK/PD substudy with additional blood sampling for PK analysis and with echocardiography imaging.
    The objective of the PK/PD sub-study is to provide data to characterize the phramacokientics of omecamtiv mecarbil after intravenous infusion doses and to correlate omecamtiv mecarbil plasma concentration and echocardiographic parameters in subjects with acute heart failure.
    E.3Principal inclusion criteria
    Subject or subject’s legally acceptable representative has provided informed consent.
    Male or female ≥ 18 years of age at the time of randomization.
    Current hospitalization for a primary reason of worsening heart failure (determined by the investigator) and requiring IV therapy for heart failure.
    History of chronic heart failure (defined as requiring treatment for heart failure for a minimum of 30 days before hospitalization).
    History of left ventricular ejection fraction (LVEF) ≤ 35% (echocardiogram, radionuclide ventriculography, cardiac magnetic resonance imaging, or contrast ventriculography) within 12 months before randomization and without a subsequent intervening value of > 35%.
    Dyspnea at rest due to heart failure at least 2 hours after having received ≥ 40 mg intravenous furosemide (or equivalent dose of an alternative loop diuretic) during the current hospitalization; dyspnea should be present at randomization.
    Brain-type natriuretic peptide (BNP) ≥ 400 pg/mL or NT-proBNP ≥ 1600 pg/mL during screening (BNP ≥ 600 pg/mL or NT-proBNP ≥ 2400 pg/mL if the subject has atrial fibrillation at presentation).
    Female subjects, if not postmenopausal or sterilized, must have a negative pregnancy test, must not be breastfeeding and must agree to abstain from sexual intercourse or use highly effective methods of birth control during treatment and for 5 days following the last dose of investigational product. Highly effective methods of birth control include: sterilization, birth control pills, Depo-Provera® injections, or contraceptive implants. Postmenopausal female is defined as 12 continuous months of spontaneous amenorrhea.
    Male subjects with a partner of childbearing potential must agree to inform their partner of their participation in this clinical study and, during treatment and for 5 days after the last dose of investigational product, to abstain from sexual intercourse or use highly effective methods of birth control, such as: vasectomy or a condom in combination with hormonal birth control or barrier methods used by the woman. For male subjects with pregnant partners, sexual abstinence or a condom must be used for 5 days after the last dose.
    If participating in the PK/PD substudy, subject must currently be in sinus rhythm.
    E.4Principal exclusion criteria
    Disease-specific
    Receiving IV vasopressor (excluding dopamine ≤ 5 μg/kg/min), inotropic or mechanical (eg, intra-aortic balloon pump counterpulsation) support between admission to the hospital and randomization.
    Subject has a pulmonary artery catheter.
    Subject requires endotracheal mechanical ventilation.
    Subject has acute coronary syndrome.
    Within 6 weeks prior to enrollment: cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation, hospitalization for acute coronary syndrome, coronary revascularization, transient ischemic attack or stroke, sustained ventricular arrhythmia, or major surgery.
    Likely to receive within 6 months after randomization, in the opinion of the investigator, planned revascularization, implantation of ICD, or CRT, ventricular assist device, continuous inotropic therapy, intermittent out-patient inotropic therapy, hospice care, or cardiac transplant.
    Severe aortic or mitral stenosis or heart failure primarily due to valvular heart disease or clinically significant valvular heart disease that might lead to surgical correction within 6 months of randomization.
    Hypertrophic obstructive cardiomyopathy, active myocarditis, or constrictive pericarditis, or clinically significant congenital heart disease.
    Chronic antiarrhythmic therapy, with the exception of amiodarone.
    Routinely scheduled outpatient IV infusions for HF (eg, inotropes, vasodilators [eg, nesiritide], diuretics) or routinely scheduled ultrafiltration.
    Evidence of digitalis intoxication.
    Other medical conditions
    Blood pressure (BP) > 160/100 mm Hg, systolic BP (SBP) < 90 mm Hg, or heart rate (HR) > 110 bpm or HR < 60 bpm at screening and confirmed by a repeat assessment.
    Estimated glomerular filtration rate (eGFR) calculated by the Modification of Diet in Renal Disease (MDRD) equation < 30 mL/min/1.73m2 at screening.
    Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 1 year.
    Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal) or receiving renal replacement therapy by dialysis.
    Receiving or has received chemotherapy and/or radiation therapy for treatment of a malignancy within 6 months prior to randomization or clinical evidence of current malignancy, with the following exceptions: localized basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
    Untreated hypothyroidism or hyperthyroidism, adrenal insufficiency, active vasculitis due to collagen vascular disease.
    Hepatic impairment defined by a total bilirubin ≥ 2 times the upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 5 times ULN at screening.
    General or other
    Previously received omecamtiv mecarbil.
    Currently enrolled in another investigational heart failure device or drug study, or less than 30 days since ending another investigational heart failure device or drug study, or receiving other investigational agent(s) for heart failure.
    Recent (within 3 months) history of alcohol or illicit drug abuse based on self-report.
    Known sensitivity to any of the products to be administered during dosing.
    Subject previously has entered this study.
    Subject will not be available for protocol-required study visits, to the best of the subject’s or investigator’s knowledge.
    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 primary endpoint is dyspnea symptom response defined as follows:
    minimally, moderately or markedly better by 7-point Likert scale at 6 hours after investigational product initiation, AND moderately or markedly better at 24 and 48 hours after investigational product initiation without worsening heart failure event or death by 48 hours.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6hrs, 24rs and 48hrs
    E.5.2Secondary end point(s)
    - Death from any cause or worsening heart failure within 7 days of initiation of investigational product
    - Worsening heart failure within 7 days of initiation of investigational product
    - Dyspnea area under the curve (AUC) (baseline to day 6 or discharge, whichever comes first) as measured by subject self-assessed Numerical Rating Scale (NRS)
    - Dyspnea by 7-point Likert scale at each scheduled assessment
    - PGA response (minimally, moderately or markedly better by subject self-assessed 7-point Likert scale at 6 hours after investigational product initiation, AND moderately or markedly better at 24 and 48 hours after investigational product initiation)
    - PGA at each scheduled assessment
    - Change from baseline in NT-proBNP at each scheduled assessment
    - Length of initial hospital stay
    - Days alive out of hospital until day 30
    E.5.2.1Timepoint(s) of evaluation of this end point
    Death from any cause or worsening HF: from the start of the IP infusion until Day 8 (7 days after IP infusion initiation)
    Worsening HF: 15, 24, 48hrs and Day 4. Day of discharge if later than day 4. If subject remains hospitalised: Days 5, 6, 7 & 8.
    Dyspnea AUC: 0, 6, 24, 48hrs & Day 4. Day of discharge if later than day 4. If the subject remains hospitalised: Days 5, 6 & 30
    Dyspnea by 7-point Likert scale: 6, 24, 48hrs & Day 4. Day of discharge if later than day 4. If subject remains hospitalised: Days 5, 6 & 30
    PGA response: 6hrs, 24hrs & 48hrs
    PGA at scheduled assessments: 6, 24, 48hrs & Day 4. Day of discharge if later than day 4. If subject remains hospitalised: Days 5, 6 & 30
    For remaining timepoints please see the protocol
    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 Yes
    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
    tolerability
    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 trial4
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Russian Federation
    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 study is defined as the last study visit (day 30) for the last subject.
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 390
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 600
    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)
    Treatment or care after the subject has ended participation in the trial is not different from the expected normal treatment for the 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 Decision2011-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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