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    Summary
    EudraCT Number:2017-002138-22
    Sponsor's Protocol Code Number:LDLL300.401
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-08-08
    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 ConcernedAustria - BASG
    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 ICUs
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study the effect of Landiolol on elevated heart rate by septic shock patients
    A.3.2Name or abbreviated title of the trial where available
    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 GmbH
    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 Orphan Pharmaceuticals GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOP Orphan Pharmaceuticals GmbH
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressLeopold-Ungar-Platz 2
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1190
    B.5.3.4CountryAustria
    B.5.4Telephone number00436649639345
    B.5.5Fax number0043150372445
    B.5.6E-maillandi-sep@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 Rapibloc 300 mg Pulver zur Herstellung einer Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderAmomed Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameRAPIBLOC (Landiolol hydrochloride lyophilized powder 300 mg/50 ml)
    D.3.4Pharmaceutical form Powder 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.3.8INN - Proposed INNLANDIOLOL HYDROCHLORIDE
    D.3.9.1CAS number 144481-98-1
    D.3.9.2Current sponsor codeLDLL300
    D.3.9.3Other descriptive nameLANDIOLOL HYDROCHLORIDE
    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 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
    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 12 hours and up to 36 hours).
    E.1.1.1Medical condition in easily understood language
    Septic shock / Tachycardia
    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 23.1
    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 (80-94 bpm) and maintenance thereof without increase in vasopressor requirements in the first 24 hours 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
    And
    Group C: will receive standard treatment according to SSCG 2016 which is not specifically targeted to the HR control
    E.2.2Secondary objectives of the trial
    To further assess efficacy and safety in the two treatment arms.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Informed consent (signed informed consent by the patient or a legal representative or other country-specific documentation, as required)
    2) Age ≥18 years
    3) 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
    4) Tachycardia and/or tachyarrhythmia with heart rate ≥95 beats/min
    5) Norepinephrine infusion (any dose) at the time of study inclusion
    6) Patients must have undergone a haemodynamic optimization period of at least 12 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
    E.4Principal exclusion criteria
    1. Any form of compensatory tachycardia
    2. β-blocker treatment after septic shock diagnosis
    3. Sick Sinus syndrome
    4. Severe atrioventricular (AV) nodal conductance disorders (without pacemaker); 2nd or 3rd degree AV block
    5. A known serious cardiovascular condition such as ischemic stroke or transient ischaemic attack within last 6 months, or preexisting heart failure New York Heart Association Class 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) exists
    12. Known sensitivity to any component of the study medication (e.g. Landiolol, mannitol)
    13. Participation in a clinical drug trial within 30 days prior randomization or prior participation in the LANDI-SEP trial
    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
    17. Anticipated to be in need of beta-blocker therapy prior to vasopressor discontinuation due to their prior medication/ medical history (Investigator ́s opinion)
    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 hours
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours
    E.5.2Secondary end point(s)
    1) Change in vasopressor requirements over the study period (dose and duration).
    2) Heart rate response (80-94bpm) during the first 24 hours.
    3) 28 day mortality (all cause).
    4) ICU mortality (all cause).
    5) Duration of ICU stay in (survivors/non-survivors).
    6) Duration of hospital stay (survivors/non-survivors).
    7) SOFA score (as long as the patient is treated with vasopressors) on day 1, 2, 3, 4, 7, 10, 13, 16, 19, 22, 25 and 28.
    8) Daily inotropic requirements (as long as the patient is treated with vasopressors).
    Secondary Safety Endpoints:
    1) Incidence rate of bradycardic episodes requiring intervention.
    2) Incidence of Adverse Events (AE). 3) Incidence of Serious Adverse Events (SAE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    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
    standard treatment for septic shock according to 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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.1.2.1Number 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
    Patients with septic shock might be unconscious at the time of inclusion and might remain unconscious or die before giving consent personally.
    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)
    None.
    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 Decision2017-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-02-16
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