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    Summary
    EudraCT Number:2017-002138-22
    Sponsor's Protocol Code Number:LDLL300.401
    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:2020-01-31
    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 number2017-002138-22
    A.3Full title of the trial
    Phase IV, multicenter, prospective, randomized, open-label, controlled study on Landiolol in patients with septic shock resident in an Intensive Care Unit
    (LANDI-SEP)
    Studio di fase IV, policentrico, prospettico, randomizzato, in aperto, controllato su Landiololo in pazienti con shock settico ricoverati in unità di cura intensiva (ICU) (LANDI-SEP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Landiolol in patients with septic shock.
    Landiololo in pazienti con shock settico.
    A.3.2Name or abbreviated title of the trial where available
    LANDI-SEP
    LANDI-SEP
    A.4.1Sponsor's protocol code numberLDLL300.401
    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 SponsorAOP ORPHAN PHARMACEUTICALS AG
    B.1.3.4CountryAustria
    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 supportAOP Pharmaceuticals AG
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOP Orphan Pharmaceuticals AG
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressWilhelminestrasse 91/II f
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1160
    B.5.3.4CountryAustria
    B.5.4Telephone number004315037244917
    B.5.5Fax number0043150372445
    B.5.6E-mailalbader.albarmawi@aoporphan.com
    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 LANDIOBLOC - "300 MG POLVERE PER SOLUZIONE PER INFUSIONE" 1 FLACONCINO IN VETRO
    D.2.1.1.2Name of the Marketing Authorisation holderAOP ORPHAN PHARMACEUTICALS AG
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLandiololo idrocloruro
    D.3.9.1CAS number 144481-98-1
    D.3.9.2Current sponsor codeLDLL
    D.3.9.4EV Substance CodeSUB21964
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult patients in ICU with septic shock who remain tachycardic (HR ≥95 bpm) and require vasopressor therapy to maintain a Mean arterial pressure (MAP) of ≥65 mmHg after a hemodynamic optimization period (at least 24 hours and up to 36 hours).
    Pazienti Adulti in Unità di Cura Intensiva per shock settico che rimangono tachicardici (HR>=95 bpm) e richiedono terapia vasopressoria per mantenere una pressione media arteriosa di >=65 mmHg dopo un periodo di ottimizzazione emodinamica (da 24 ore almeno, fino a 36 ore).
    E.1.1.1Medical condition in easily understood language
    Tachycardia in septic shock.
    Tachicardia in shock settico
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10043071
    E.1.2Term Tachycardia
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10040070
    E.1.2Term Septic shock
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the rate of patients with heart rate response and maintenance thereof without increase in vasopressor requirements. in the first 24 hours after treatment start, in a septic shock population with persistent tachycardia (≥95bpm), randomized to either Group L or Group C. Group L: will receive standard treatment according to SSCG 2016 and treatment with LDLL300 for the duration of vasopressor treatment. Group C: will receive standard treatment according to SSCG 2016 which is not specifically targeted to the heart rate control. SSCG=Surviving Sepsis Campaign (SSC) Guidelines 2016
    Confrontare la proporzione dei pazienti con risposta per la frequenza cardiaca e il suo manutenimento senza incrementare il fabbisogno di farmaci vasopressori, nelle prime 24 ore dopo l'inizio del trattamento, in una popolazione in shock settico, con tachicardia persistente (≥95bpm), randomizzata a gruppo L o gruppo C. Gruppo L: riceverà un trattamento standard secondo SSCG 2016 e trattamento con LDLL300 per la durata del trattamento con il farrmaco vasopressore. Il gruppo C riceverà un trattamento standard secondo SSCG 2016 che non è specificamente destinato al controllo della frequenza cardiaca. SSCG = Guida per la campagna di seppia sopravvissuta (SSC) 2016.
    E.2.2Secondary objectives of the trial
    To further assess efficacy and safety in the two treatment arms
    Valutare ulteriormente sicurezza ed efficacia nei due bracci di trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Confirmed septic shock:
    a. Confirmed or suspected infection
    b. Acute increase of ≥2 points on SOFA Score
    c. Need for continuous vasopressor therapy to maintain a mean arterial pressure (MAP) of >65 mmHg despite adequate fluid resuscitation
    d. Blood lactate >2mmol/L (18mg/dl)
    Presence of blood lactate >2mmol/L (18mg/dl) and increase of ≥2 points on SOFA Score are only necessary for the diagnosis of septic shock but not at time of study inclusion
    2) Tachycardia and/or tachyarrhythmia with heart rate ≥95 beats/min
    3) Norepinephrine infusion rate ≥0.2μg/kg/min at the time of study inclusion
    4) Patients must have undergone a hemodynamic optimization period of at least 24 hours but a maximum of 36 hours, during which period they received continuous vasopressor treatment and standard treatment for septic shock according to the SSCG 2016 guidelines
    5) Age ≥18 years
    1) Shock settico confermato:
    a. Infezione confermata o sospetta
    b. aumento acuto di ≥2 punti sul punteggio SOFA
    c. necessità di terapia continua con vasopressore per mantenere una pressione arteriosa media (MAP) di> 65 mmHg nonostante un'adeguata rianimazione per i liquidi
    d. Lattato serico> 2mmol / L (18mg / dl)
    La presenza di lattato nel sangue> 2mmol / L (18mg / dl) e un aumento di ≥2 punti sul punteggio SOFA sono necessari solo per la diagnosi dello shock settico, ma non al momento dell'inserimento dello studio
    2) Tachicardia e / o tachiaritmia con frequenza cardiaca ≥95 battiti / min
    3) Tasso di infusione di noradrenalina ≥ 0,2 μg / kg / min al momento dell'inserimento dello studio
    4) I pazienti devono aver subito un periodo di ottimizzazione emodinamica di almeno 24 ore, ma non più di 36 ore, durante il quale hanno ricevuto un trattamento continuo di vasopressore e un trattamento standard per lo shock settico secondo le linee guida SSCG 2016
    5) Età ≥18 anni
    E.4Principal exclusion criteria
    1.Any form of compensatory tachycardia
    2.β-blocker treatment within 7 days prior randomization
    3.Sick Sinus syndrome, or 2nd or 3rd degree AV block
    4.Patients with any form of cardiac pacing
    5.A known serious cardiovascular condition such as ischemic stroke or transient ischemic attack within last 6 months, or preexisting heart failure New York Heart Association Class III or IV
    6.Cardiogenic shock
    7.MAP <65 mmHg
    8.Known pulmonary hypertension
    9.Known terminal illness other than septic shock with expected patient's survival <28 days
    10.Known presence of an advanced condition to withhold life-sustaining treatment
    11.Patients for whom a "Do Not Resuscitate" (DNR) exist
    12.Known sensitivity to any component of the study medication (e.g. mannitol)
    13.Participation in a clinical drug trial within 30 days prior randomization
    14.Any condition that, in the Investigator's opinion, makes the subject unsuitable for study participation (to be documented)
    15.Pregnant or breast-feeding patients
    16.Untreated Pheochromocytoma
    1. Qualsiasi forma di tachicardia compensativa
    2. Trattamento con beta-bloccanti entro 7 giorni prima della randomizzazione
    3. Sindrome del Nodo Malato, o blocco AV del 2°, 3° grado.
    4. Pazienti con qualsiasi forma di stimolazione cardiaca
    5. Una condizione cardiovascolare grave nota come ictus ischemico o attacco ischemico transitorio negli ultimi 6 mesi, o preesistente insufficienza cardiaca New York Heart Association Classe III o IV
    6. shock cardiogenico
    7. MAP (Pressione Arteriosa Media) <65 mmHg
    8. Ipertensione polmonare nota
    9. Malattia terminale conosciuta (tranne lo shock settico) con sopravvivenza del paziente attesa <28 giorni
    10. Presenza nota di una condizione avanzata per non procedere a trattamento di sostegno vitale
    11. Pazienti per i quali esiste un "Non Resuscitate" (DNR Do Not Resuscitate)
    12. Sensibilità nota a qualsiasi componente del farmaco in studio (ad esempio mannitolo)
    13. Partecipazione a uno studio clinico con farmaco entro 30 giorni prima della randomizzazione
    14. Qualsiasi condizione che, a giudizio del ricercatore, renda inadatto il soggetto alla partecipazione allo studio (da documentare)
    15. Pazienti in stato di gravidanza o in allattamento
    16. Phechromocytoma non trattato
    E.5 End points
    E.5.1Primary end point(s)
    Heart rate response (80-94 bpm) and maintenance thereof and no increase in vasopressor requirements during the first 24 hour
    Risposta della frequenza cardiaca (80-94 bpm) e suo mantenimento di seguito, e nessun incremento nel fabbisogno di farmaco vasopressore nel corso delle prime 24 ore.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 24 hs.
    Fino a 24 ore.
    E.5.2Secondary end point(s)
    SAFETY
    1) Incidence rate of bradycardic episodes requiring intervention. 2) Incidence of Adverse Events (AE). 3) Incidence of Serious Adverse Events (SAE)
    SICUREZZA
    1) Incidenza degli episodi bradicardici che richiedono intervento 2) Incidenza Eventi Avversi 3) Incidenza di Eventi Avversi Gravi
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study period
    Periodo dello studio
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Trattamento standard per la condizione in studio, facendo riferimento alle linee guida SSCG 2016
    Standard treatment for the condition under study,
    referring to the the SSCG 2016 Guidelines.
    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 EEA12
    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 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
    LVLS
    LVLS
    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.1.1Number of subjects for this age range: 1
    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.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    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 a condition which makes them incapable of giving consent personally, and who need urgent care.
    Soggetti con una condizione che li rende incapaci di dare il consenso personalmente, e che hanno bisogno di cure urgenti.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    Not applicable.
    Non applicabile.
    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 Decision2018-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
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