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    Summary
    EudraCT Number:2008-007407-86
    Sponsor's Protocol Code Number:LevoRep
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-007407-86
    A.3Full title of the trial
    Efficacy and safety of pulsed infusions of levosimendan in outpatients with advanced heart failure
    A.4.1Sponsor's protocol code numberLevoRep
    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 SponsorMedizinische Universität Innsbruck - Universitätsklinik für Innere Medizin III
    B.1.3.4CountryAustria
    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 Yes
    D.2.1.1.1Trade name Simdax 2.5 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation, Finland
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameLevosimendan
    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 use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevosimendan
    D.3.9.1CAS number 141505-33-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 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 No
    D.3.11.8Extractive medicinal product No
    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
    Chronic heart failure
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic 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 efficacy objective of the study is to compare the effects of a pulsed application of Levosimendan versus placebo of the composite end-point functional capacity and quality of life.
    E.2.2Secondary objectives of the trial
    The secondary efficacy objectives are to determine the effects of a pulsed administration of levosimendan on:
    a) short-term (8 weeks from randomization) and long-term (24 weeks from randomization) event-free survival (cardiac death or heart failure-related hospitalization),
    b). Components of primary endpoints (6-minute walk test and KCCQ) will be analysed as separate endpoints.

    Cardiac death will be divided into arrhythmic death and pump failure death. Adjudication of endpoints is assigned to the independent Data Safety and Monitoring Board.

    The tertiary efficacy objective is to determine theeffect of a pulsed application of levosimendan on:
    a) marker of inflammatory activation (IL-6, IL-10 and TNF-alpha)
    b) markers of the apaptotic process (Afas, SFAS, Ligand),
    c) markers of oxidative stress (MDA, protein carbonyls, nitrotyrosine)
    d) markers of disease severity (NT-pro-BNP)
    e) weight
    f) dose of diuretics
    g) creatinine clearance and
    h) cost effectiveness
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    MRI Sub-study:

    Aim of the substudy:

    - Proof evidence for reverse remodeling and improvement of left ventricular function by Levosimendan,
    - Assessment of hibernating myocardium activated by Levosimendan.

    Economic Valuation Sub Study:

    Aim of the study:

    - To determine the cost-effectiveness of pulsed infusion of Levosimendan in outpatients with advanced heart failure.
    E.3Principal inclusion criteria
    - Patients with chronic stable heart failure NYHA III and IV diagnosed at least 3 months before inclusion
    - 6-min.-walk-test < 350 meters
    - EF < 35 %
    - age > 20 years
    - optimized and individualised neurohormonal background therapy according to ESC-guidelines for the treatment of chronic heart failure.
    - Patient has signed informed consent
    E.4Principal exclusion criteria
    → Hospitalization for decompensated heart failure requiring i.v. diuretics within
    the last month before randomization
    → History of torsades des pointes
    → Allergy to Levosimendan or any of the excipients
    → Administration of inotropes in the last 4 weeks
    → Potassium < 3,5 and >5,5 mmol/l
    → Systolic blood pressure <= 100 mmHg
    → For Austria and Greece:
    Women at childbearing age without using effective contraceptives ( oral
    contraceptives, intrauterine contraceptive devices) unless surgical sterilisation has been undertaken.
    → For Germany:
    Women of childbearing age unless surgical sterilisation has been undertaken
    → Female patients who are pregnant or nursing
    → Creatinin Clearance < 30ml/min/m2
    → Severe anemia (Hb < 10 mg /dl)
    → Mechanical obstruction affecting the ventricular filling or the outflow or
    both
    → Patients with non compliance
    → Severe conditions, which make the patient unsuitable to participate in a study as judged by the investigator
    → Severe liver disease
    → Percutaneous coronary intervention within the last 1 months
    → Coronary bypass surgery within the last 3 months
    → Planned HTX within the next six months
    → Patient involved in another clinical trial
    → De-nove heart failure
    → Implantation of a cardiac resynchronisation device during the last three months
    E.5 End points
    E.5.1Primary end point(s)
    Proporation of patients showing an improvement in the six-minutes walk-testof 20 % or more and 15 % or higher scoring in the Kansas City Cardiomyopathy Questionnaire (KCCQ) at the end of the 28 week study period.
    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 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) Yes
    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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 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
    End of the Trial = Last Patient - Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) No
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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 Decision2011-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-01-31
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