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    Summary
    EudraCT Number:2004-005213-11
    Sponsor's Protocol Code Number:NES103694
    National Competent Authority:Iceland - IMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-03-14
    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 ConcernedIceland - IMCA
    A.2EudraCT number2004-005213-11
    A.3Full title of the trial
    A multi-centre, randomised, double-blind, parallel group study assessing the efficacy and safety of IV nesiritide versus placebo, in addition to background care, in the treatment of subjects with acute decompensated heart failure. Evaluating Treatment with Nesiritide in Acute Decompensated Heart Failure (ETNA).
    A.3.2Name or abbreviated title of the trial where available
    ETNA
    A.4.1Sponsor's protocol code numberNES103694
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 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.2.5The 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 namenesiritide
    D.3.2Product code GW832810
    D.3.4Pharmaceutical form Powder 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 INNnesiritide
    D.3.9.2Current sponsor codeGW832810
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.58
    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) 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 placeboPowder 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 decompensated heart failure (adHF)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10000803
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to assess the efficacy and safety of IV nesiritide versus placebo, in addition to background care, in the treatment of subjects with adHF managed in an inpatient setting reflecting mainstream clinical practice.
    Primary Objective
    • To evaluate the efficacy of nesiritide versus placebo, in addition to background care by assessing dyspnoea and well-being at 3 hours and 6 hours after the start of investigational product.
    The study will be considered a success if improvement in subject self-assessed dyspnoea (at either 3 or 6 hours, or both) and in subject self-assessed well-being (at either 3 or 6 hours, or both) is shown.
    E.2.2Secondary objectives of the trial
    • To assess the effect of nesiritide versus placebo, in addition to background care, on other efficacy parameters including mortality and readmissions, clinical status and endpoints relating to length of hospital stay and degree of care required
    • To assess the safety of nesiritide versus placebo, in addition to background care, in subjects with adHF
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    A subject will be considered eligible for inclusion in this study only if all of the
    following criteria apply:
    1. Male or female, at least 18 years of age and who has been hospitalised for the management of a primary diagnosis of adHF. Note for the small number of female subjects of childbearing potential who may enter the study an effective method of contraception must be used for the duration of the study (up to Day 30)
    2. The underlying primary aetiology of adHF and the presenting symptoms should be cardiac disease, rather than pulmonary disease (e.g. not cor pulmonale, nor pneumonia in addition to chronic HF)
    3. In relation to the acute episode, subjects must have at least one sign of heart failure as detailed below:
    • tachypnoea (> 20 breaths/minute)
    • increased jugular venous pressure (JVP), or 3rd/4th heart sound, or recent clinically significant weight gain indicative of oedema, or hepatic congestion.
    • crackles/rales or pulmonary effusion evident on chest auscultation/ examination.
    4. In relation to the acute episode, subjects must have at least one piece of investigational evidence consistent with heart failure as detailed below:
    • a chest X-ray upon admission with evidence of pulmonary congestion
    • Left ventricular systolic ejection fraction performed within the past 12 months - Left ventricular ejection fraction should be ≤45% or the equivalent rating of at least moderately impaired left ventricular systolic function.
    5. Subjects must still have dyspnoea at rest or on minimal exertion (e.g. on sitting up) at the time of randomisation
    6. Subjects must have received at least one but not more than two doses of IV bolus diuretic within 24 hours prior to randomisation AND/OR, have been receiving a continuous infusion of IV diuretics for at least 2 hours immediately prior to randomisation at a constant dose. Bolus IV diuretic is not permitted within 1 hour prior to randomisation. The subject must be randomised within 24 hours of the initiation of IV treatment for HF.
    7. Chronicity of HF must be substantiated by: 1) documented clinical history of chronic HF and 2) investigational evidence of left ventricular systolic dysfunction (e.g. by echocardiography, ventriculography or nuclear cardiography) within the last 12 months. A current assessment (e.g. echocardiographic) can be performed if this information is not available from the medical history at the time of screening. NB: Left ventricular ejection fraction should be ≤45% or the equivalent rating of at least moderately impaired left ventricular systolic function
    8. The subject or legal representative must fully understand and sign the written informed consent prior to initiation of protocol-specified procedures.
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria apply:
    1. Initiation of IV treatment for HF > 24 hours prior to randomisation
    2. Hospitalised for ≥48 hours prior to randomisation
    3. Baseline SBP
    a. Subjects who have not received or are not receiving either IV vasodilators (e.g. nitrates) or inotropes prior to randomisation are excluded if SBP ≤ 100mmHg.
    b. Subjects who have received or are receiving either IV vasodilators (e.g. nitrates) or inotropes prior to randomisation are excluded if SBP < 120mmHg
    4. a. Subjects receiving continuous iv diuretics, iv vasodilators, or iv inotropes prior to randomisation whose dose has not remained stable for 2 hours prior to randomisation.
    b. Subjects receiving iv vasodilators, or iv inotropes whose SBP is unstable (e.g. progressively falling) or has fallen below 120mmHg within 2 hours prior to randomisation.
    5. Known or suspected acute coronary syndrome (ST-elevation or non-ST elevation myocardial infarction (MI) or unstable angina pectoris) within the past 2 weeks.
    6. Cardiogenic shock, evidence of uncorrected volume or sodium depletion (e.g. excessive diuresis or clinical signs of dehydration) or other clinical condition that would contraindicate the administration of IV vasoactive agents
    7. Evidence of malignant hypertension or severe persistent uncontrolled hypertension (blood pressure >190/115 mmHg).
    8. History of unexplained syncope
    9. Requiring mechanical ventilation, or mechanical circulatory support (e.g. intraaortic balloon pump, left ventricular assist devices) (subjects receiving CPAP prior to randomisation may be recruited), or likely to require dialysis or other renal replacement therapy post randomisation, or likely to undergo percutaneaous coronary intervention (PCI) or emergency surgery during admission.
    10. Subjects who have been resuscitated or received defibrillation during the admission prior to randomisation.
    11. Known allergic reaction to nesiritide or other IV therapy that may be critical to successful management of adHF (e.g. nitrate, inotropes, diuretics)
    12. The following co-morbidities: cardiac valvular stenosis, restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, pericardial tamponade or any condition likely to cause intolerance to vasodilators, severe pulmonary disease, concurrent pneumonia,
    13. adHF associated with: underlying congenital heart disease, thyrotoxicosis (or other conditions associated with high output cardiac failure), active myocarditis; or with uncontrolled haemodynamically relevant atrial fibrillation/flutter; or with ventricular rhythm disturbances or secondary to clinical evidence of digoxin toxicity or any other drug-related toxicity.
    14. Subjects with other significant, non-cardiac, co-morbidities (e.g. cancer) who are not anticipated to survive the 6 month follow-up
    15. Subjects whose condition requires long term IV vasoactive support (e.g. heart transplant candidate) or subjects whose acute cardiovascular condition is unlikely to be sufficiently improved to enable the subject to be discharged following study therapy
    16. Subjects who have undergone a heart transplant or who are waiting to undergo transplant surgery
    17. Subjects who have undergone coronary artery bypass graft (CABG) surgery or other cardiac/ major non-cardiac surgery within the past 30 days
    18. Therapy with another investigational drug within 5 half lives prior to the time of study entry which had not been pre-approved by GSK
    19. Prior therapy with nesiritide
    20. Pregnancy, suspected pregnancy or breast feeding
    21. Unwillingness or inability to comply with study requirements
    22. This note is applicable to French-participating centres only:
    A subject will not be eligible for inclusion into this study if any of the following criteria apply:
    • The subject is not either affiliated to or beneficiary of a social security category.
    • The subject will participate simultaneously in another clinical trial.
    The exclusion period after the completion of this study (Day 30) will be 5 months.
    E.5 End points
    E.5.1Primary end point(s)
    Co-Primary Endpoints:
    • Subject self-assessed dyspnoea at 3 hours
    • Subject self-assessed dyspnoea at 6 hours
    • Subject self-assessed well being at 3 hours
    • Subject self-assessed well being at 6 hours
    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 Yes
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    As per protocol: All subjects will be considered to have completed the study upon completion of assessments and procedures up to and including the Day 30 visit (Day 30 post randomistiaon) or if the subject dies prior to the Day 30 follow up.
    A long term follow-up of subjects will involve monthly collection of survival status up to Day 180 post randomisation.
    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 months6
    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 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 2005-03-14. 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
    Subjects with symptoms of adHF so severe (e.g. breathlessness) that may not be capable of giving consent. In such situations, the procedure for obtaining consent from a legal representative will be followed as per the local country regulations.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1500
    F.4.2.2In the whole clinical trial 1900
    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)
    As expected normal treatment of 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 Decision2005-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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