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    Summary
    EudraCT Number:2021-001954-76
    Sponsor's Protocol Code Number:TV48531-CV-40190
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-11-18
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2021-001954-76
    A.3Full title of the trial
    A Randomized Open Label, Parallel Group Study to Evaluate the Hemodynamic Effects of Cafedrine/Theodrenaline vs Norepinephrine in the Treatment of Intraoperative Arterial Hypotension in Adults after Induction of General Anesthesia
    Hämodynamische Effekte von Cafedrin/Theodrenalin (Akrinor) vs Noradrenalin zur Behandlung der intraoperativen Hypotonie unter Allgemeinanästhesie: eine randomisierte, kontrollierte Studie in Deutschland
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Test if Cafedrine/Theodrenaline is better than Norepinephrine in treating Intraoperative Arterial Hypotension in Adults during General Anesthesia
    Studie, die Cafedrin/Theodrenalin mit Noradrenalin in der Behandlung des intraoperativen Blutdruckabfalls während Vollnarkose vergleicht.
    A.3.2Name or abbreviated title of the trial where available
    HERO
    A.4.1Sponsor's protocol code numberTV48531-CV-40190
    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 SponsorRatiopharm GmbH Teva EU Medical Affairs
    B.1.3.4CountryGermany
    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 supportratiopharm
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationratiopharm GmbH
    B.5.2Functional name of contact pointDr Susanne Huljic-Lankinen
    B.5.3 Address:
    B.5.3.1Street AddressGraf-Arco Straße 3
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89079
    B.5.3.4CountryGermany
    B.5.4Telephone number00497314025738
    B.5.6E-mailmedical.affairs@teva.de
    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 Akrinor
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Solution for injection
    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 INNCAFEDRINE HYDROCHLORIDE
    D.3.9.1CAS number 3039-97-2
    D.3.9.4EV Substance CodeSUB00934MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTHEODRENALINE HYDROCHLORIDE
    D.3.9.1CAS number 2572-61-4
    D.3.9.4EV Substance CodeSUB04779MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Sinora
    D.2.1.1.2Name of the Marketing Authorisation holderSintetica
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namenorepinephrine
    D.3.4Pharmaceutical form Concentrate for 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.3.8INN - Proposed INNNOREPINEPHRINE
    D.3.9.1CAS number 51-41-2
    D.3.9.2Current sponsor code2201012.00.00
    D.3.9.3Other descriptive namenorepinephrine tartrate
    D.3.9.4EV Substance CodeSUB09360MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    The purpose of the study is to comparatively evaluate the hemodynamic effects of two treatments when intraoperative hypotension occurs.
    Patients who require advanced hemodynamic monitoring and develop intraoperative hypotension will be treated with either Cafedrin/Theodrenaline or Noradrenaline after randomisation to one of two study arms.

    Der Gegenstand der klinischen Prüfung ist die Behandlung eines intraoperativen Blutdruckabfalls mit zwei Vergleichspräparaten. Dazu werden Patienten, die ein erhöhtes Risiko haben, auf die Vollnarkose mit einem signifikanten Blutdruckabfall zu reagieren, in zwei Studienarme randomisiert. Es werden die hämodynamischen Effekte des Test-Medizinprodukts Cafedrin/Theodrenalin und des Referenzprodukts Noradrenalin verglichen.
    E.1.1.1Medical condition in easily understood language
    Patients with heart failure who undergo general anesthesia in connection with surgery may go on to drop their blood pressure seriously low and develop so-called intraoperative hypotension.
    Patienten mit Herzversagen haben eine erhöhtes Risiko bei Einleitung einer Vollnarkose im Zusammenhang mit einem chirurgischen Eingriff mit einem ernsten Blutdruckabfall zu reagieren.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10062300
    E.1.2Term Procedural hypotension
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    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 the study is to compare the hemodynamic effects of the test and reference IMPs administered as bolus injection and subsequent as continuous infusion in a surgical cohort of at-risk adult patients who develop intraoperative hypotension .
    Das Primärziel ist, in einer Kohorte von Patienten, die ein erhöhtes Risiko aufweisen, intraoperativ eine arterielle Hypotonie zu entwickeln, die hämodynamischen Effekte des Test- und Vergleichspräparats, die zunächst als Bolus, dann -bei gegebener Indikationslage- als Infusion verabreicht werden, zu vergleichen.
    E.2.2Secondary objectives of the trial
    The secondary effectiveness objectives of the study are to compare hemodynamic measures and study procedures during study phase 1 („bolus phase“, 0-20 Minutes after initial treatment of intraoperative arterial hypotension).
    Sekundärziele sind der Vergleich hämodynamischer Eingriffe und Behandlungsmaßnahmen während der Studienphase 1 (Bolus-Phase, 0-20 Minuten nach Beginn der Behandlung der arteriellen Hypotension).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patient is capable of giving signed informed consent as described in Appendix B which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol;
    The patient is at least 50 years of age with chronic cardiac failure (NYHA-stages: II-III), is of ASA-Classification: 3 or 4, and has an indication for arterial cannulation and advanced hemodynamic monitoring prior to induction of general anesthesia;
    The patient is undergoing elective vascular surgery with general anesthesia using Propofol/Fentanyl or Propofol/Sufentanil.
    Unterschriebene Einwilligungserklärung
    Der Patient/die Patientin ist mindestens 50 Jahre alt, hat chronisches Herzversagen (NYHA Stadien: II-III), ist ASA-risikoklassifiziert mit 3 oder 4, und es besteht vor Einleitung der Vollnarkose die Indikation für einen arteriellen Zugang sowie erweitertes hämodynamisches Monitoring.
    Der Patient/die Patientin unterzieht sich eines gefäßchirurgischen Wahleingriffs mit Vollnarkose durch Propofol/Fentanyl oder Propofol/Sufentanil.
    E.4Principal exclusion criteria
    The patient has a known hypersensitivity to any components of the IMPs stated in this protocol;
    The patient has a known hypersensitivity to sodium metabisulfite;
    The patient has bronchial asthma with sulfite hypersensitivity;
    The patient has diagnosis of clinical relevant mitral stenosis;
    The patient has diagnosis of clinical relevant aortic stenosis;
    The patient has a diagnosis of hyperthyroidism;
    The patient has a diagnosis of pheochromocytoma;
    The patient is going to receive any cardiac sensitizing agent (e.g. cyclopropane or halothane) or is going to have deep hypoxia or hypercapnia concomitant to application of IMP;
    The patient has uncontrolled hypertension as co-morbidity;
    The patient has sepsis, septic shock, or systemic inflammatory response syndrome (SIRS);
    The patient is on the following classes of medication that were not withheld on the day of surgery: ACE-Inhibitor /AT2-Antagonists or MAO-Inhibitors.
    Use of regional anesthesia during study phase 1 and/or study phase 2;
    The patient is going to receive inhalation anesthesia during study phase 1 and/or 2.
    The patient cannot exclude pregnancy based on a negative pregnancy test (blood or urine sample) or medical history (menopause, sterilization, amenorrhea).
    Überempfindlichkeit gegenüber Prüf- oder Vergleichspräparat
    Überempfindlichkeit gegenüber Natriummetabisulfit
    Der Patient/die Patientin hat Bronchialasthma mit Sulfitüberempfindlichkeit
    Der Patient/die Patientin hat eine klinisch relevante Mitralstenose
    Der Patient/die Patientin hat eine klinisch relevante Aortenklappenstenose
    Der Patient/die Patientin hat eine Hyperthyreose
    Der Patient/die Patientin hat ein Phäochromozytom
    Für den Patient/die Patientin ist die Verabreichung kardial sensitivierender Medikamente (wie Cyclopropan oder Halothan) vorgesehen oder der Patient/die Patientin wird tiefe Hypoxie oder Hyperkapnie zeitgleich zur Verabreichung des Prüf- oder Vergleichspräparats entwickeln.
    Der Patient/die Patientin ist mit unkontrolliertem Bluthochdruck komorbid.
    Der Patient/die Patientin hat Sepsis, septischen Schock oder Systemisches inflammatorisches response Syndrom (SIRS)
    Der Patient/die Patientin nimmt die folgende Klasse Medikamente ein, die nicht am Tage des chirurgischen Eingriffs pausiert wurde: ACE Inhibitor/AT2-Antagonisten oder MAO-Inhibitoren
    Einsatz einer Regionalanästhesie während Studienphase 1 oder 2.
    Der Patient/die Patientin wird eine Inhalationsanästhesie während Studienphase 1 oder 2 bekommen.
    Die Patientin kann eine Schwangerschaft nicht aufgrund eines negativen Schwangerschaftstests ausschließen (Blut oder Urintest) oder aufgrund der Anamnese (Menopause, Sterilisation, Amenorrhoe).
    E.5 End points
    E.5.1Primary end point(s)
    (1) Treatment related difference in average MAP [DaMAP] during study phase 2, calculated as the mean difference between areas below the target MAP value (90 mmHg). Non-inferiority is assumed, if DaMAP can be shown to be lower than the non-inferiority margin (5 mmHg) at one-sided alpha-level 0.025.
    (2) Treatment related difference in average Cardiac Index [DaCI] during study phase 1, calculated as the difference in means of individual areas above the CIref.* Superiority is concluded, if a positive DaCI can be shown at one-sided alpha-level 0.025.
    Die Differenz im mittleren arteriellen Druck während der Studienphase 2 (Infusionsphase) bezogen auf die Behandlungen (Zieldruck 90 mmHg);
    Die Differenz im mittleren kardialen Index (individuell berechnet) während der Studienphase 1 (Bolusphase) bezogen auf die Behandlungen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The duration of the study phases is two times 20 minutes. Hemodynamic measurements are conducted continuously, however.
    Die Dauer der zwei Studienphasen beträgt jeweils zwanzig Minuten, allerdings werden die hämodynamischen Messungen kontinuierlich erhoben.
    E.5.2Secondary end point(s)
    (1) Treatment related difference in average MAP [DaMAP] during study phase 1. The estimated DaMAP will be presented along with its two-sided 95% confidence interval.
    (2) Treatment related differences in:
    a. change in HR
    b. change in SVI
    c. change in SVRI
    d. change of dP/dtmax
    during study phase 1. The estimated treatment related differences will be presented along with their two-sided 95% confidence interval.
    (3) Ratio of treatment specific incidence rates of overshooting blood pressure (MAP > 110 mmHg) events during study phase 1. The estimated incidence rate ratio will be presented along with its two-sided 95% confidence interval.
    (4) Ratio of treatment specific incidence rates of low blood pressure (MAP <80 mmHg) events during study phase 1. The estimated incidence rate ratio will be presented along with its two-sided 95% confidence interval.
    (5) Treatment related differences in number of:
    a. additional bolus-injections (at MAP <70 mmHg)
    b. additional measures (volume, position changes etc.)
    necessary to stabilize blood pressure during study phase 1, where both entities the corresponding contrasts between treatments will be presented along with their two-sided 95% confidence intervals
    Die Differenz im mittleren arteriellen Druck während der Studienphase 1 bezogen auf die Behandlungen;
    bezogen auf die Behandlungen, Veränderungen von Herzfrequenz, Schlagvolumenindex, systemischem Gefäßwiderstandsindex, maximaler ventrikulärer Druckanstiegsgeschwindigkeit;
    bezogen auf die Behandlungen, Unterschiede in den Inzidenzen überschießenden Blutdrucks (mittlerer arterieller Druck größer als 110 mmHg);
    bezogen auf die Behandlungen, Unterschiede in den Inzidenzen eines zu niedrigen Blutdrucks (mittlerer arterieller Druck kleiner als 80 mmHg)
    bezogen auf die Behandlungen, Unterschiede in der Anzahl zusätzlicher Bolusgaben (wenn der mittlere arterielle Druck kleiner als 70 mmHg ist) sowie Anzahl zusätzlicher Maßnahmen wie z.B. Volumengabe oder Positionswechsel
    E.5.2.1Timepoint(s) of evaluation of this end point
    The duration of this study phase is 20 minutes. Hemodynamic measurements are conducted continuously, however.
    Die Dauer dieser Studienphase beträgt zwanzig Minuten, allerdings werden die hämodynamischen Messungen kontinuierlich erhoben.
    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 No
    E.6.5Efficacy No
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned9
    E.8.5The trial involves multiple Member States No
    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
    The end of study is defined as the 24-hour assessment of adverse reactions postoperatively for the last patient.
    Das Studienende ist definiert als die Erhebung unerwünschter Ereignisse 24 Stunden postoperativ für den letzten Patienten.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state220
    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 Decision2022-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-29
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