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    Summary
    EudraCT Number:2004-002732-25
    Sponsor's Protocol Code Number:0105
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-09-22
    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 ConcernedNorway - NOMA
    A.2EudraCT number2004-002732-25
    A.3Full title of the trial
    Safety and efficacy of levosimendan in patients with acute myocardial infarction complicated by symptomatic left ventricular failure
    A.4.1Sponsor's protocol code number0105
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGeir Øystein Andersen, Department of Cardiology, Ulleval University Hospital
    B.1.3.4CountryNorway
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Simdax
    D.2.1.1.2Name of the Marketing Authorisation holderAbbot Scandinavia AB
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameSimdax
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlevosimendan
    D.3.9.2Current sponsor code0105
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number0.1 per min
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Patients with acute myocardial infarction developing acute heart failure after primary PCI (percutaneus coronary intervention). Some patients in a predefined subgroup are categorized as patients in cardiogenic shock. See study protocol (2) for details.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the safety and efficacy of a 24-hour infusion with levosimendan compared to placebo, in patients with acute myocardial infarction complicated with decompensated heart failure after acute revascularization by PCI. The main efficacy endpoints are changes in regional contractility of the myocardium (wall motion score index) measured by echocardiography, changes in brain natriuretic peptide and a clinical composite score evaluating changes in patients symptoms. Additional endpoints are safety endpoints: Hypotension, arrhythmias and ischaemic episodes.
    E.2.2Secondary objectives of the trial
    Evaluate the effect of the IMP on the length of stay in coronary care unit and the total length of stay in hospital.
    Evaluate the effect of the IMP on rehospitalization, new myocardial infarction and mortality (MACE).
    Evaluate the effect of the IMP on infarct size measured by gated spect.
    Evaluate the effect of the IMP on inflammation markers, haemostasis parameters and serum lactate.

    In a subroup of patients in cardiogenic shock: Evaluate the effect of the IMP on days on intra-aortic-balloon counter pulsation treatment, in-hospital mortality, kidney function and central venous oxygen saturation.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients who are hospitalised with acute ST-segment elevation myocardial infarction (STEMI: ECG definition) subjected to acute PCI
    or
    patients with non-ST segment elevation myocardial infarction subjected to PCI within 72 hours after start of chest pain.

    and all of the following (1-3)
    o Revascularization by PCI with opening of an occluded coronary artery or balloon dilatation of a stenotic coronary artery presumed to be culprit lesion.
    o Left-ventricular ejection fraction (EF) must be less than 40% measured by echocardiography.
    o Dyspnoea at rest at screening and at least one of the following signs of left ventricular failure:
    • Pulmonary edema
    • Signs of marked pulmonary congestion on chest x-ray
    • Need for continuous-elevated positive airway-pressure ventilation (CPAP) or mechanical ventilation
    • Need for IV diuretics.
    • Oliguria (<0.5 ml/kg/hour) as a sign of hypoperfusion of the kidneys after volume therapy.
    Subgroup of patients with cardiogenic shock:
    A prospectively defined subgroup included by stratified randomisation.

    Additional inclusion criteria includes both of the following:
    o Systolic BP <90 mmHg after 60 min of adequate volume therapy or systolic BP between 90 and 100 mmHg with inotropic support by catecholamine infusion
    o Signs of hypoperfusion (low-output heart failure)
    • Oliguria (diuresis <0.5 ml/kg/hour)
    • Cold, clammy extremities
    • Reduced consciousness
    E.4Principal exclusion criteria
    o Age below 20 years,
    o Heart rate above 120 bpm
    o Septic shock
    o ARDS
    o Creatinine >450 μmol/l
    o Hepatic impairment
    o Significant mechanical outlet obstruction
    o Allergy against study drug medication or one of its ingredients
    o Anaemia (Hb < 8 g/dl)
    o Pregnancy
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy parameters:
    o Changes from baseline to 5 days in Wall motion score-index measured by echocardiography.
    o Changes from baseline to 5 days in BNP (Brain natriuretic peptide).
    o Clinical composite at 5 days after start of the study drug infusion, according to the physician’s global assessment measured as change from baseline to 5 days.

    Safety parameters: Number of patients developing:
    o Hypotension: BP < 90 mm Hg or a drop in mean arterial BP > 10 mm Hg in patients with cardiogenic shock.
    o Tachcardia (heart rate above 120).
    o Atrial fibrillation.
    o Ventricular arrhythmia (VT, VF, TDP).
    o Ischaemic episodes (ECG changes or chest pain demanding treatment).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.3 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 trial is completed after (all 4)
    1) the inclusion of 60 patients in the main study.
    2) at least 14 of the 60 patients in a predefined subgroup of patients in cardiogenic shock.
    3) all patients alive have been controlled after 6 weeks.
    4) all patients have been followed for at least one year in order to observe mortality and reinfarction.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-09-22. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In the subgroup of patients in cardiogenic shock (14 out of 60 patients). These patients are usually sedated and in need of mechanical ventilation.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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)
    Regular treatment of patients with heart failure post -myocardial infarction.
    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 Decision2006-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-05
    P. End of Trial
    P.End of Trial StatusOngoing
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