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    Summary
    EudraCT Number:2011-000805-27
    Sponsor's Protocol Code Number:MEIN/10/Ran-Did/001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-08-02
    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 number2011-000805-27
    A.3Full title of the trial
    Effect on Ranolazine in Heart Failure Patients with Preserved Ejection Fraction
    Effetto di Ranolazina in pazienti con Insufficienza Cardiaca con Frazione di Eiezione Preservata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Ranolazine in Heart Failure Patients
    Effetto di Ranolazina in pazienti con Insufficienza Cardiaca
    A.3.2Name or abbreviated title of the trial where available
    ERIPE
    ERIPE
    A.4.1Sponsor's protocol code numberMEIN/10/Ran-Did/001
    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.1.1Name of SponsorMENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
    B.1.3.4CountryLuxembourg
    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 supportMenarini International Operations Luxembourg S.A.
    B.4.2CountryLuxembourg
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationA. Menarini Farmaceutica Internazionale S.R.L.
    B.5.2Functional name of contact pointDonatella Bemporad
    B.5.3 Address:
    B.5.3.1Street AddressVia Sette Santi, 3
    B.5.3.2Town/ cityFirenze
    B.5.3.3Post code50131
    B.5.3.4CountryItaly
    B.5.4Telephone number0039 055 5680685
    B.5.5Fax number0039 055 5680484
    B.5.6E-maildbemporad@menarini.it
    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 nameRANOLAZINE
    D.3.2Product code GS9668
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRANOLAZINE
    D.3.9.1CAS number 95635-55-5
    D.3.9.2Current sponsor codeI 293
    D.3.9.4EV Substance CodeSUB10259MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number500 to 1000
    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 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 placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Heart failure patients with preserved ejection fraction (HFpEF)
    Pazienti con insufficienza cardiaca e frazione di eiezione preservata
    E.1.1.1Medical condition in easily understood language
    Patients with heart failure
    Pazienti con 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 14.1
    E.1.2Level SOC
    E.1.2Classification code 10007541
    E.1.2Term Cardiac disorders
    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 objective is to demonstrate that ranolazine treatment results in a placebo corrected improvement in the 6-minute walk test (6MWT) after 28 weeks of treatment
    Dimostrare che la terapia con ranolazina determina un miglioramento con correzione in base al placebo del test del cammino di 6 minuti (6MWT) dopo 28 settimane di trattamento
    E.2.2Secondary objectives of the trial
    Mitral flow velocity to mitral annular velocity ratio (E/E') from baseline to 6 months Mitral flow: maximum velocity during early diastole (VmaxE); maximal velocity during atrial contraction (VmaxA); deceleration time of E wave; isovolumetric relaxation time (IVRT) Tricuspidal regurgitation Vmax of septal and lateral E' measured by Tissue Doppler Echocardiography (TDE) 2D strain evaluation: longitudinal systolic strain, LV twist, global diastolic longitudinal strain rate during isovolumic relaxation (IVR) and early diastole/untwisting rate Arterial elastance (LV end systolic pressure/stroke volume) and LV end systolic elastance (LV end systolic pressure/LV end systolic volume) Diastolic pressure/volume ratio measured as (E/E')/end diastolic volume Myocardial Performance Index (MPI; included in ECHO protocol) N-terminal prohormone brain natriuretic peptide (NT-proBNP)
    Il rapporto velocità del flusso diastolico transmitralico/velocità anulare mitralica (E/E’) dal basale a 6 mesi Flusso transmitralico: velocità massima durante la protodiastole (VmaxE); velocità massima durante la contrazione atriale (VmaxA); tempo di decelerazione dell'onda E; tempo di rilassamento isovolumetrico (IVRT) Rigurgito tricuspidale: Vmax del gradiente sistolico ventricolo destro-atrio destro Vmax di E' settale e laterale misurati tramite Doppler tissutale (TDE) Analisi ecocardiografica dello strain 2D: strain sistolico longitudinale,twist del ventricolo sinistro,strain rate diastolico longitudinale durante il rilassamento isovolumetrico (IVR) e rapporto protodiastole/movimento di torsione contraria (untwisting) Elastanza arteriosa (pressione termino-sistolica/gittata sistolica dell'LV) ed elastanza telesistolica dell'LV (pressione termino-sistolica LV/volume telesisto
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female between the ages of 40 to 85 years, inclusive 2. Heart failure with preserved EF defined by the following: a. Signs or symptoms of HF (previous documented hospitalization for HF, decompensation in the last 12 months, or exertional dyspnea or XML File Identifier: S4AwUhkYufh0YjTScxWWrhyDBgE= Page 10/21 fatigue, New York Heart Association [NYHA] Class II-IV with or without clinical signs of HF) b. LVEF > 45% measured by echocardiogram c. NT-ProBNP > 200 pg/ml or BNP > 80 pg/ml d. Evidence of LV diastolic dysfunction or increased LV filling pressure documented in the last month and defined by the following: • LV end diastolic pressure > 16 mmHg • or E/E' > 15 (septal annular velocity) • or E/E' between 8 and 15 and at least one of the following: – Plasma brain natriuretic peptide (BNP) > 150 pg/ ml or plasma N terminal pro b-type natriuretic peptide (NT proBNP) > 450 pg/ml – Ratio of early (E) to late (A) mitral valve flow velocity (E/A) < 0.5 and mitral flow deceleration time (DT E) > 280 ms – LV atrial area > 25 cm² (apical 4 chamber) – LV posterior wall thickness > 12 mm e. Sinus rhythm 3. Written informed consent 4. 6MWT distance ≤ 450 meters and ≥ 100 meters at screening
    Pazienti di sesso maschile o femminile di età compresa fra 40 e 85 anni, compresi 2. Insufficienza cardiaca con frazione di eiezione (FE) conservata, stabilita da quanto segue: a. segni o sintomi di insufficienza cardiaca (HF) (precedente ospedalizzazione documentata per HF, scompenso negli ultimi 12 mesi o dispnea da sforzo o affaticamento, classe II-IV secondo la New York Heart Association [NYHA] con o senza segni clinici di HF) b. frazione di eiezione del ventricolo sinistro (LVEF) &gt; 45% misurata mediante ecocardiogramma c. NT-ProBNP &gt; 200 pg/ml o BNP &gt; 80 pg/ml d. evidenza di disfunzione diastolica del VS o di aumento della pressione di riempimento del VS documentata nell’ultimo mese e definita come segue: • pressione telediastolica del VS &gt; 16 mmHg • o E/E’ &gt; 15 (velocità anulare settale) • o E/E’ fra 8 e 15 e almeno uno dei seguenti parametri: - peptide natriuretico cerebrale plasmatico (BNP) &gt; 150 pg/ ml o peptide natriuretico n-terminale plasmatico di tipo pro-b (NT-proBNP) &gt; 450 pg/ml - rapporto della velocità di flusso della valvola mitralica precoce (E)/tardiva (A) (E/A) &lt; 0,5 e tempo di decelerazione del flusso mitralico (DT E) &gt; 280 ms - area atriale del VS &gt; 25 cm² (apicale 4 camere) - spessore della parete posteriore del VS &gt; 12 mm e. ritmo sinusale 3. consenso informato scritto 4. distanza 6MWT ≤ 450 metri e ≥ 100 metri allo screening
    E.4Principal exclusion criteria
    1. Unstable situation for acute acute coronary syndrome, or worsening angina in the last 3 months 2. Unstable situation for acute heart failure in the last month 3. Poor echogenicity 4. Significant chronic lung disease (e.g., chronic obstructive pulmonary disease, asthma), prior hospitalization for acute exacerbation, home oxygen use, chronic inhaled or systemic steroid therapy 5. Documented hypertrophic or restrictive cardiomyopathy 6. Body mass index (BMI) ≥ 30 kg/m2 7. Tricuspid Rigurgitation Max Velocity > 4m/s 8. Previous Heart Failure hospitalization or decompensation, with documented LV Systolic Dysfunction (LVEF ≤ 45%) 9. Sustained atrial fibrillation or flutter in the previous 3 months 10. Change in cardiovascular medication during the last 4 weeks 11. Change in diuretic medication during the last 2 weeks 12. Revascularization within the last 3 months 13. Second- or third-degree atrioventricular (AV) block 14. Severe and uncontrolled hypertension stage 3 (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg) 15. Significant valvular disease: moderate or severe mitral or aortic valve disease 16. Severe renal impairment (creatinine clearance < 30 ml/min) 17. Moderate or severe hepatic impairment (Child-Pugh Class A or Class B) 18. Previous cardiac surgery 19. Inability to perform the 6MWT 20. 6MWT distance > 450 meters or < 100 meters at screening 21. Screening and baseline 6-minute walk distance (6MWD) with >10% variability 22. Stroke within the last 3 months 23. Implantable pacemaker for chronotropic incompetence, cardioverter defibrillator, or LV assist device 24. Prior heart transplantation 25. Current treatment with potent inhibitors of CYP3A, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir 26. Current treatment with CYP3A inducers, such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John`s wort 27. Concomitant administration of Class Ia (e.g., quinidine) or Class III (e.g., dofetilide, sotalol) antiarrhythmics other than amiodarone 28. Use of greater than 1000mg daily dose of metformin during the study 29. Use of over 20 mg daily of simvastatin 30. Prior treatment with ranolazine 31. Hypersensitivity to the active substance or to any of the excipients 32. Participation in another trial of an investigational drug or device within 30 days prior to screening 33. Pregnant or breast-feeding 34. Severe psychiatric disorders/neurological disorders 35. Abuse of alcohol, analgesics, or psychotropic drugs 36. Disabling or terminal illness 37. Inability or unwillingness, in the Investigator`s opinion, to follow study procedures
    1. Situazione instabile per sindrome coronarica acuta o peggioramento dell’angina negli ultimi 3 mesi 2. Situazione instabile per insufficienza cardiaca acuta nell’ultimo mese 3. Ecogenicità scarsa 4. Patologia polmonare cronica significativa (ad esempio, pneumopatia cronica ostruttiva, asma), precedente ospedalizzazione per esacerbazione acuta, uso di ossigeno a casa, terapia cronica a base di steroidi per via inalatoria o sistemica 5. Cardiomiopatia ipertrofica o restrittiva documentata 6. Indice di massa corporea (IMC) ≥ 32 kg/m 7. Velocità massima di rigurgito tricuspidale &gt; 4m/s 8. Precedente ospedalizzazione per insufficienza cardiaca o scompenso, con disfunzione sistolica del VS documentata (LVEF ≤ 45%) 9. Fibrillazione atriale sostenuta o flutter nei precedenti 3 mesi 10. Variazione della terapia cardiovascolare durante le ultime 4 settimane 11. Variazione della terapia diuretica durante le ultime 2 settimane 12. Rivascolarizzazione negli ultimi 3 mesi 13. Blocco atrioventricolare (AV) di secondo o terzo grado 14. Ipertensione grave e incontrollata allo stadio 3 (pressione arteriosa sistolica &gt; 180 mmHg o pressione arteriosa diastolica &gt; 100 mmHg) 15. Patologia valvolare significativa: patologia valvolare mitralica o aortica di grado moderato o grave 16. Disfunzione renale grave (clearance della creatinina &lt; 30 ml/min). 17. Disfunzione epatica moderata o grave (classe A o B di Child-Pugh). 18. Precedente intervento cardiaco 19. Incapacità di svolgere il test 6MWT 20. Distanza 6MWT &gt; 450 metri o &lt; 100 metri allo screening 21. Distanza del cammino di 6 minuti (6MWD) allo screening e al basale con variabilità &gt;10% 22. Ictus negli ultimi 3 mesi 23. Pacemaker per insufficienza cronotropa, defibrillatore cardioverter o sistema di assistenza ventricolare impiantabili 24. Precedente trapianto cardiaco 25. Trattamento attuale con potenti inibitori del CYP3A, compresi chetoconazolo, itraconazolo, claritromicina, nefazodone, nelfinavir, ritonavir, indinavir e saquinavir 26. Trattamento attuale con induttori del CYP3A quali rifampicina, rifabutina, rifapentina, fenobarbitale, fenitoina, carbamazepina ed Erba di San Giovanni 27. Somministrazione concomitante di antiaritmici di classe Ia (ad esempio chinidina) o di classe III (ad esempio dofetilide, sotalolo) diversi da amiodarone 28. Impiego di una dose giornaliera di metformina durante lo studio superiore ai 1.000 mg 29. Impiego di una dose giornaliera di simvastatina superiore ai 20 mg Precedente trattamento con ranolazina 30. Precedente trattamento con Ranolazina 31. Ipersensibilità al principio attivo o a uno qualsiasi degli eccipienti 32. Partecipazione a un altro studio clinico condotto su un farmaco o su un dispositivo sperimentale nei 30 giorni antecedenti lo screening 33. Gravidanza o allattamento al seno 34. Gravi disturbi psichiatrici/neurologici 35. Abuso di alcol, analgesici, o farmaci psicotropi 36. Patologia invalidante o terminale 37. Incapacità o riluttanza, secondo l’opinione dello Sperimentatore, a seguire le procedure dello studio
    E.5 End points
    E.5.1Primary end point(s)
    6-minute walk test
    Test del cammino di 6 minuti
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 16 and 28 weeks
    Dopo 16 e 28 settimane
    E.5.2Secondary end point(s)
    Central blinded Echolab evaluation NT-proBNP(13) Quality of Life scale (Minnesota Living with HF Questionnaire) Electrocardiogram Safety assessments
    Valutazione centralizzata in cieco del Echolab NT-proBNP Scala della quaolita' della vita (Minnesota living with HF questionnaire) Elettrocardiogramma Acceratmenti di sicurezza
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 16 and 28 weeks
    Dopo 16 e 28 settimane
    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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 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
    LVLS
    LVLS
    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 months18
    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 months18
    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.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    According to the clinical practice
    In accordo alla pratica clinica
    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 Decision2012-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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