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    EudraCT Number:2009-013929-42
    Sponsor's Protocol Code Number:39588146AHF2001
    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:2011-12-06
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2009-013929-42
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JNJ-39588146 in Subjects with Heart Failure
    Uno studio randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per studiare la sicurezza, la tollerabilita`, la farmacodinamica e la farmacocinetica di JNJ-39588146 in soggetti con insufficienza cardiaca.
    A.4.1Sponsor's protocol code number39588146AHF2001
    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.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 supportJANSSEN CILAG SPA
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJANSSEN CILAG SPA
    B.5.2Functional name of contact pointGCO
    B.5.3 Address:
    B.5.3.1Street AddressVia M. Buonarroti
    B.5.3.2Town/ cityCologno Monzese
    B.5.3.3Post code20093
    B.5.4Telephone number+39 02 2510569
    B.5.5Fax number+39 02 2510537
    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 nameSTRESSCOPIN
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeJNJ-39588146
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number.2
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboSolution 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
    Heart failure
    Scompenso cardiaco
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10011949
    E.1.2Term Decompensation cardiac
    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
    Assess the hemodynamic effects, the safety and the tolerability of JNJ-39588146 when administered by intravenous infusion to male subjects and female subjects of non-childbearing potential with New York Heart Association (NYHA) Class II-IV heart failure.
    Valutare gli effetti emodinamici, la sicurezza e la tollerabilita' di JNJ-39588146 somministrato tramite infusione endovenosa a soggetti di sesso maschile e femminile potenzialmente non fertili, affetti da insufficienza cardiaca di classe NYHA (New York Heart Association) II o IV.
    E.2.2Secondary objectives of the trial
    Characterize the pharmacokinetics of JNJ-39588146 in subjects with heart failure.
    Caratterizza la farmacocinetica di JNJ-39588146 in soggetti affetti da insufficienza cardiaca.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sottostudio dal titolo "Assess the hemodynamics for an 18-hour extended infusion. Assess the effect of JNJ-39588146 on relevant cardiovascular biomarkers detected in blood sample" vedi protocollo
    Sottostudio dal titolo "Assess the hemodynamics for an 18-hour extended infusion. Assess the effect of JNJ-39588146 on relevant cardiovascular biomarkers detected in blood sample" vedi protocollo
    E.3Principal inclusion criteria
    1. Subjects must have signed an informed consent document indicating that they understand the purpose of the study and the procedures required for the study and are willing to participate in the study. 2. Subjects must have systolic dysfunction (LVEF ≤0.35, documented within the 6 months prior to dosing by any quantitative method) and Heart Failure (New York Heart Association [NYHA] functional class II-IV). Subjects considered by the principal investigator as having end-stage or refractory heart failure characterized by severe cachexia, restriction to bed rest, hospice status or are in imminent need (within the next 30 days) of a left ventricular assist device or heart transplant should not be considered for the study.Have a pulmonary capillary wedge pressure ≥20 mm Hg immediately prior to the initiation of the infusion. 3. Have a cardiac index ≤2.5 L/min/m2 immediately prior to the initiation of the infusion. 4. Subjects must have supine blood pressure (after resting for 5 min) between the range of 95 - 160 mm Hg systolic (inclusive), and 50 - 89 mm Hg diastolic (inclusive) at screening and Day 1 pre-dose. 5. Must not have received intravenous heart failure medications including inotropes, vasodilators or diuretics, for at least 18 hours prior to initiation of study infusion. Subjects requiring intravenous medications to control their heart failure (such as inotropes and/or vasodilators within the next 48 hours and/or diuretics within the next 24 hours) should not participate in the study. If there is a planned elective evaluation of a subject’s cardiac response to inotropes/vasodilators, they may participate in the study if the planned elective treatment with these agents is ≥4 hours after the end of the study drug infusion. 6.Serum potassium within normal limits confirmed within 2 week of the study drug infusion. If there has been a change in diuretic therapy within these past 2 weeks, serum potassium must be within normal limits within 24 hours of dosing. 7. Subjects must have a body mass index (BMI) between 18 to 35 kg/m2 (inclusive) and with a minimum body weight of 50 kg. 8. Female subjects must be of non-childbearing potential, defined as either being: - postmenopausal (for at least 24 months) or, - surgically sterile for more than 6 months prior to participation in the study (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), and must have a negative serum b-human chorionic gonadotropin (b-hCG) pregnancy test at screening; and a negative urine pregnancy test on admission to the clinical study unit. 9. Male subjects must consent to utilize a medically acceptable method of contraception throughout the study and for 3 months after the last dose of study drug and to not donate sperm during the study and for 3 months after receiving the last dose of study drug. Medically acceptable methods of contraception that may be used by the subject and/or the partner include double barrier method (condom, diaphragm, or cervical cap used with intravaginal spermicidal foam, cream, or gel), IUD, surgical sterilization (6 months post surgery), post-menopausal partner (not experiencing a menstrual period for a minimum of two years) and hormonal contraceptives (which must be used consistently for 3 months prior to run-in) such as oral contraceptives, hormonal patches, progestin implants or injections, and etonogestrel/ethinyl estradiol vaginal rings (NuvaRing). 10. Male or female subjects between 18 and 86 years of age, inclusive. 11.Willing/able to adhere to the prohibitions and restrictions specified in this protocol.
    1. I soggetti devono aver firmato un modulo di consenso informato indicante che hanno compreso lo scopo dello studio e le relative procedure e che intendono prendervi parte. 2. I soggetti devono essere affetti da disfunzione diastolica (LVEF ≤0.35, documentata nei 6 mesi antecedenti alla somministrazione attraverso un metodo quantitativo) e da insufficienza cardiaca (di Classe NYHA [New York Heart Association] II-IV). I soggetti che lo sperimentatore principale riterra` affetti da insufficienza cardiaca refrattaria o allo stadio terminale, caratterizzata da cachessia grave, necessita` di riposo a letto o di cure palliative oppure che hanno l`impellente necessita` (entro i successivi di 30 giorni) di un dispositivo di assistenza ventricolare sinistra o di trapianto cardiaco non dovrebbero essere presi in considerazione per lo studio. I soggetti devono presentare una pressione di incuneamento capillare polmonare ≥20 mm Hg subito prima dell`avvio dell`infusione. 3. I soggetti devono avere un indice cardiaco ≤2.5 L/min/m2 subito prima dell`avvio dell`infusione. 4. I soggetti devono presentare una pressione arteriosa sistolica, in posizione supina (dopo un riposo di 5 min) compresa tra 95 160 mm Hg (inclusi), e la diastolica tra 50 - 89 mm Hg (inclusi) allo screening e al Giorno 1 di pre-somministrazione. 5.Non devono aver ricevuto farmaci per l`insufficienza cardiaca per via endovenosa, inclusi inotropi, vasodilatatori o diuretici, nelle 18 ore antecedenti l`avvio dell`infusione dello studio. I soggetti che necessiteranno di farmaci per controllare l’insufficienza cardiaca (quali inotropi e/o vasodilatatori entro le successive 48 ore e/o diuretici entro le successive 24 ore). non devono partecipare allo studio. Nel caso in cui sia stata programmata una valutazione elettiva della risposta cardiaca del soggetto al trattamento con inotropi/vasodilatatori, tali soggetti potranno partecipare allo studio solo se la conduzione del trattamento elettivo con questi agenti sara` prevista almeno dopo 4 ore dal termine dell’infusione del farmaco sperimentale. 6. I valori di potassio nel siero devono essere confermati entro i limiti di normalita` durante le due settimane dall’infusione del farmaco sperimentale.Nel caso in cui dovesse verificarsi un cambiamento nella terapia con diuretici, durante le due settimane antecedenti l’infusione, i valori di potassio nel siero dovranno essere nella norma durante le 24 ore di somministrazione. 7. I soggetti devono avere un indice di massa corporea (BMI) compreso tra 18 e 35 kg/m2 (inclusi) e avere un peso corporeo minimo di 50 kg. 8. I soggetti di sesso femminile devono essere potenzialmente non fertili, essendo quindi: - in menopausa (da almeno 24 mesi), o - clinicamente sterili da piu` di 6 mesi prima della partecipazione allo studio (avendo subito isterectomia od ooforectomia bilaterale, legatura delle tube o in quanto non considerate fertili), devono presentare un test di gravidanza ß-gonadotropina corionica umana (ß-hCG) in siero negativo allo screening e un test di gravidanza sulle urine negativo al momento dell`ammissione al centro in cui si effettua lo studio clinico. 9. Gli uomini devono acconsentire a utilizzare un metodo contraccettivo accettabile sul piano medico per l`intera durata dello studio e per i 3 mesi successivi all`ultima assunzione del farmaco sperimentale e a non donare lo sperma durante lo studio e nei 3 mesi successivi all`assunzione dell`ultima dose del farmaco sperimentale. Metodi contraccettivi accettabili a livello clinico e quindi utilizzabili dal soggetto e/o dal proprio partner possono comprendere metodo a doppia barriera (ossia preservativi, diaframma o cappuccio cervicale usato con spermicida vaginale in forma di schiuma, crema o gel), dispositivo intrauterino, sterilizzazione chirurgica (da almeno 6 mesi)....
    E.4Principal exclusion criteria
    1. Subjects without bundle branch block with confirmed screening QTcF interval >450 msec in males or > 470 msec in females. Subjects with bundle branch block or receiving amiodarone with confirmed screening QTcF interval >500 msec. Subjects with a history of additional risk factors for torsades de pointe (e.g., hypokalemia, family history of Long QT Syndrome), or the use of concomitant medications that prolong the QT/QTc interval. 2. Subjects with atrial fibrillation, sinus tachycardia, sustained ventricular tachycardia, ventricular fibrillation within the last 30 days or third degree heart block at screening or check-in. 3. Subjects with a resting heart rate less than 50 or greater than 100 beats per minute (via ECG output predose). 4. Acute coronary syndrome, myocardial infarction or coronary revascularization (CABG or percutaneous coronary intervention) within 1 month or history of resuscitated sudden death or systemic shock. 5. Subjects with a left-ventricular assist device or heart transplant or mechanical ventilation. 6. Subjects with hemodynamically-significant primary valvular heart disease. 7. Subjects with serum digoxin concentrations (minimum levels) >1.5 ng/ml at screening. 8. Subjects in whom the PA catheter is being placed solely for study measurements, with an INR >1.5 when femoral, subclavian or jugular approach is used. 9. History of transient ischemic attack within the 6 months before screening. 10. History of clinically significant chronic hepatic, reproductive, gastrointestinal, primary renal, hematologic, pulmonary, neurologic, respiratory or psychiatric disorders, and oncologic conditions or acute or chronic infection. 11. Subjects with uncontrolled hypertension or/and uncontrolled diabetes. 12. Subjects with ALT or AST greater than 3 times the upper limit of normal at screening may not participate in the study. 13. Subjects with creatinine clearance <30 mL/min at screening or subjects requiring dialysis or serum ultra-filtration. 14. Any condition that, in the opinion of the Investigator, would compromise the well being of the subject or the study or prevent the subject from meeting or performing study requirements. 15. Subjects for which there is a concern of right intra-ventricular lead displacement including subjects who have had placement of pacemaker or ICD within the past 3 months before screening. 16. Subjects with heart failure caused by myositis, lung disease, congenital heart disease, constrictive pericarditis, or hypertrophic or restrictive cardiomyopathy. 17. Subjects planning to parent a child during the study or within 3 months after the last dose of study drug. 18. Pregnant or breast-feeding females. 19. Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator. 20. Known allergies, hypersensitivity, or intolerance to JNJ-39588146 or its excipients (refer to Section 14.1, Physical Description of Study Drug(s)), or urocortin or urocortin 2.
    1. Soggetti senza blocco di branca con intervallo QTcF &gt; 450 msec nei maschi o &gt; 470 msec nelle femmine confermato in screening. Soggetti con blocco di branca o che assumano amiodarone con intervallo QTcF &gt; 500 msec confermato in screening. Soggetti con pregressi fattori di rischio addizionali per torsioni di punta (cioe` ipocalemia, storia familiare di sindrome del QT lungo) o che utilizzino farmaci concomitanti che prolungano l`intervallo QT/QTc. 2. I soggetti che abbiano presentato fibrillazione atriale, tachicardia sinusale, tachicardia ventricolare prolungata, fibrillazione ventricolare negli ultimi 30 giorni o un blocco cardiaco di terzo grado durante lo screening o al ricovero. 3. Soggetti con frequenza cardiaca a riposo inferiore a 50 o superiore a 100 battiti al minuto (rilevato tramite ECG prima della somministrazione). 4. Sindrome coronarica acuta, infarto miocardico o rivascolarizzazione coronarica (CABG o intervento coronarico percutaneo) nell`ultimo mese o precedenti di morte improvvisa resuscitata oppure di shock sistemico. 5. Soggetti con dispositivo di assistenza ventricolare sinistra o trapianto cardiaco o ventilazione meccanica. 6. Soggetti affetti da patologia cardiaca valvolare primaria di rilevanza emodinamica. 7. Soggetti con concentrazioni di digossina in siero (livelli minimi) &gt; 1,5 ng/ml allo screening. 8. Soggetti nei quali il catetere polmonare arterioso sia stato applicato esclusivamente per le misurazioni connesse allo studio, con un INR &gt; 1,5 in caso di utilizzo di approccio femorale, succlavio o giugulare. 9. Precedenti di attacco ischemico transitorio nei 6 mesi antecedenti lo screening. 10. Precedenti di disturbi epatici cronici, riproduttivi, gastrointestinali, renali primari, ematologici, polmonari, neurologici, respiratori o psichiatrici di rilevanza clinica, nonche` di condizioni oncologiche o infezione cronica o acuta. 11. Soggetti affetti da ipertensione incontrollata e/o diabete incontrollato. 12. Soggetti con ALT o AST superiori a 3 volte il limite superiore di normalita` allo screening, non potranno partecipare allo studio. 13. Soggetti con clearance della creatinina nel siero &lt;30 ml/minuto allo screening o che necessitino di dialisi o di ultrafiltrazione del siero. 14. Qualsiasi condizione che, secondo il giudizio dello sperimentatore, comprometterebbe il benessere del soggetto o lo studio o che impedirebbe al soggetto di corrispondere o adempiere ai requisiti dello studio. 15. I soggetti per i quali si tema lo spostamento intraventricolare destro della guida, inclusi i soggetti a cui e` stato applicato un pacemaker o ICD nei 3 mesi antecedenti lo screening. 16. Soggetti con insufficienza cardiaca provocata da miosite, malattia polmonare, disfunzione cardiaca congenita, pericardite costrittiva o cardiomiopatia ipertrofica o restrittiva. 17. Soggetti che prevedano di diventare genitori durante lo studio o durante i 3 mesi successivi all`ultima assunzione del farmaco sperimentale. 18. Donne in gravidanza o allattamento al seno. 19. Dipendenti dello sperimentatore o del centro di ricerca con un coinvolgimento diretto riguardo allo studio proposto o ad altri studi sotto la direzione di detto sperimentatore o centro di ricerca, come pure i membri del nucleo familiare dei dipendenti o dello sperimentatore. 20. Allergia, ipersensibilita` o intolleranza nota a JNJ-39588146 o ai relativi eccipienti (fare riferimento alla sezione 14.1, Descrizione fisica del farmaco sperimentale) o a urocortina o urocortina 2.
    E.5 End points
    E.5.1Primary end point(s)
    Two primary endpoints are the post-baseline changes (at 1-hour, 2 hours and 3 hours post infusion initiation) in pulmonary capillary wedge pressure and cardiac index. The two primary endpoints will be used separately to compare JNJ-39588146 with placebo.
    Gli end-points primari sono: la variazione della pressione polmonare capillare e dell'indice cardiaco a partire dai valori di baseline rispetto a quelli a 1 ora/2 ore/3 ore dall'inizio dell'infusione. I 2 end-points primari saranno usati separatamente per paragonare JNJ-39588146 con il placebo.
    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 Yes
    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. 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 trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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.1.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 60
    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 Decision2010-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-05
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