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    Summary
    EudraCT Number:2007-001670-84
    Sponsor's Protocol Code Number:JNJ-27410084
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-03
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-001670-84
    A.3Full title of the trial
    Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure
    A.3.2Name or abbreviated title of the trial where available
    ASCEND-HF
    A.4.1Sponsor's protocol code numberJNJ-27410084
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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.1.3.4CountryItaly
    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 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 nameNesiritide
    D.3.4Pharmaceutical form Powder 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 codeJNJ 27410084
    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 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 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
    Decompensated Hearth Failure
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10061216
    E.1.2Term Infarction
    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 this study is to evaluate whether treatment with nesiritide improves patient outcomes (as measured by reduction in the composite of HF rehospitalization and all-cause mortality through 30 days after randomization [Day 30]) or HF symptoms (as measured by subject self-assessed Likert dyspnea scale at 6 and 24 hours after study drug initiation) compared with placebo when each is administered in addition to other standard therapies in subjects with ADHF.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate the effect of treatment with nesiritide, compared with placebo, when each is administered in addition to standard care in ADHF, in: · Improving subject self-assessed overall well-being at 6 or 24 hours after study drug initiation · Increasing the number of days alive and outside of the hospital from randomization through Day 30 · Reducing the composite of cardiovascular rehospitalization and cardiovascular mortality from randomization through Day 30
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Men or women 18 years of age or older -Hospitalized for the management of ADHF or diagnosed with ADHF within 48 hours after being hospitalized for another reason -The diagnosis of ADHF must meet the following definition: – Dyspnea at rest or dyspnea with minimal activity (i.e., difficulty breathing at rest while sitting, or difficulty breathing while lying flat or with 1 pillow, or difficulty breathing with minimal activity such as talking, eating), AND – At least 1 of the following signs: – Tachypnea with respiratory rate >20 breaths per minute, OR – Pulmonary congestion/edema with rales or crackles/crepitations at least one-third above lung base, AND – At least 1 of the following objective measures: – Chest x-ray with pulmonary congestion/edema, OR – B-type natriuretic peptide >0=400 pg/mL or NT-proBNP >O=1,000 pg/mL at presentation, OR – Pulmonary capillary wedge pressure >20 mmHg, OR – Ejection fraction <40% measured by any modality (echocardiography, nuclear testing, cardiac MRI, ventricular angiography) within 12 months before randomization without intervening revascularization or cardiac surgery · Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. · Signed (by the subjects or their legally acceptable representatives) informed consent form for pharmacogenomic research indicating consent or refusal to participate in the pharmacogenomic component of the study. Participation in this component is not required for participation in the clinical study.
    E.4Principal exclusion criteria
    · Hospitalized for >o=48 hours before randomization · Likely to be discharged from the hospital in 24 hours or less · At high risk for hypotension: – Baseline SBP <100 mmHg or – Systolic blood pressure <110 mmHg with i.v. nitroglycerin or another i.v. vasodilator used at baseline · Persistent, uncontrolled hypertension (SBP >180 mmHg) · Have any of the following cardiovascular disease parameters: – Echocardiogram (ECG) with new ST elevation >1 mm in 2 consecutive leads – Acute coronary syndrome as primary diagnosis – A coronary catheterization or other coronary intervention is planned within 48 hours – History of cardiac valvular stenosis, restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, or pericardial tamponade – Cardiac index >2.5 l/min/m2 or PCWP <o=20 mmHg, or both, within 6 hours before randomization (only if measured) – Have a left ventricular assist device · Medication History: – Received first i.v. treatment of diuretics, vasodilators or inotropes for HF more than 24 hours before randomization – Treated with levosimendan or milrinone within 30 days before randomization or anticipated need for one of these medications during the current hospitalization – Treated with i.v. nitroglycerin, i.v. dobutamine <5 mg/kg/min or another i.v. vasoactive medication, the dosage of which is not stable for 3 hours before randomization – Treated with dobutamine <o=5 mg/kg/min. at the time of randomization – Had prior therapy with nesiritide in the past 30 days, or anticipate the need for open-label nesiritide during the current hospitalization – Known allergic reaction or hypersensitivity to nesiritide · Laboratory abnormalities (when laboratory values are available) – Troponin level >5 times the upper limit of normal (ULN) – Creatine kinase - MB (CK-MB) levels >3 times ULN – BNP or NT-proBNP is within normal limits (i.e., BNP <100 pg/mL or NT-proBNP <125 pg/mL for subjects <75 years old; NT proBNP <425 pg/mL for subjects >o=75 years old) · Comorbid Diseases – Chronic or intermittent renal support therapy (hemodialysis, ultrafiltration, or peritoneal dialysis) – Significant chronic or acute lung disease that might interfere with the ability to interpret the dyspnea assessments (e.g., severe chronic obstructive pulmonary disease, active asthma or acute pneumonia) – Serious comorbid disease in which the life expectancy of the subject is less than 6 months – e.g., acute systemic infection – sepsis, metastatic cancer or other serious illnesses – Anemia, defined as hemoglobin <9 mg/dL (<5.6 mmol/L) or hematocrit <27% – Active gastrointestinal bleeding · Received an experimental drug or used an experimental medical device within 30 days before randomization · Previous enrollment in a nesiritide study · Pregnant, suspected to be pregnant, or breast-feeding · Unwillingness or inability to comply with study requirements (including subjects whose cooperation is doubtful due to drug abuse or alcohol dependency)
    E.5 End points
    E.5.1Primary end point(s)
    SEE OBJECTIVES
    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 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.8.4.1Number of sites anticipated in Member State concerned14
    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 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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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) 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 Yes
    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 2008-06-03. 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3000
    F.4.2.2In the whole clinical trial 7000
    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 Decision2008-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-03-15
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