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    The EU Clinical Trials Register currently displays   42869   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-001675-37
    Sponsor's Protocol Code Number:Lis-Safe
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-06-14
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-001675-37
    A.3Full title of the trial
    A Prospective, Open-label, Exploratory Study to Investigate the Safety, Efficacy, and Haemodynamics of Lisuride Subcutaneous Infusion as Add-on to Conventional Treatment in Patients with Pulmonary Arterial Hypertension
    Eine prospektive, offene, explorative Studie zur Beurteilung der Sicherheit, Wirksamkeit und Auswirkungen auf die Hämodynamik von subkutanen Lisurid-Infusionen zusätzlich zur Standardtherapie bei Patienten mit Pulmonaler Arterieller Hypertonie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate the Effects of Lisuride in addition to Conventional Treatment in Patients with Pulmonary Arterial Hypertension
    Studie zur Beurteilung der Wirkungen von Lisurid zusätzlich zur Standardbehandlung bei Patienten mit Pulmonaler Arterieller Hypertonie
    A.3.2Name or abbreviated title of the trial where available
    Lis-Safe
    A.4.1Sponsor's protocol code numberLis-Safe
    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 SponsorSinoxa Pharma GmbH
    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 supportSinoxa Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSinoxa Pharma GmbH
    B.5.2Functional name of contact pointMedical Department
    B.5.3 Address:
    B.5.3.1Street AddressKönigin-Luise-Str. 27
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code14195
    B.5.3.4CountryGermany
    B.5.4Telephone number004903028869878
    B.5.5Fax number004903028869696
    B.5.6E-mailr.horowski@sinoxa.eu
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/11/869
    D.3 Description of the IMP
    D.3.1Product nameLisuride
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLisuride
    D.3.9.1CAS number 18016-80-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Pulmonary Arterial Hypertension
    Pulmonale Arterielle Hypertonie
    E.1.1.1Medical condition in easily understood language
    High blood pressure in lung arteries
    Hoher Blutdruck in den Lungenarterien ("Lungenhochdruck")
    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 LLT
    E.1.2Classification code 10036727
    E.1.2Term Primary pulmonary hypertension
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective: To investigate the safety of continuous treatment with sc lisuride infusions as add-on treatment to stable conventional therapy in patients with pulmonary arterial hypertension (PAH).
    Primäres Ziel: Untersuchung der Sicherheit kontinuierlicher subkutaner Lisurid-Infusionen als zusätzliche Therapie zu einer stabilen konventionellen Therapie bei Patienten mit Pulmonaler Arterieller Hypertonie (PAH).
    E.2.2Secondary objectives of the trial
    Secondary objective: To investigate the efficacy of continuous treatment with sc lisuride infusions as add-on treatment to stable conventional therapy in patients with pulmonary arterial hypertension (PAH).
    Sekundäres Ziel: Untersuchung der Wirksamkeit kontinuierlicher subkutaner Lisurid-Infusionen als zusätzliche Therapie zu einer stabilen konventionellen Therapie bei Patienten mit Pulmonaler Arterieller Hypertonie (PAH).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female and male patients of any racial origin with PAH (WHO classification II-III).
    2. On stable treatment with best supportive care with conventional PAH therapy, i.e. anticoagulant drugs, diuretics, cardiac glycosides, supplemental oxygen and calcium channels blockers, adjusted to the individual need of the respective patient. Specific PAH mono-therapy (preferably with Bosentan) or combination-therapy (not exceeding two PAH specific drugs) with either endothelin receptor antagonists or phosphodiesterase type 5 inhibitors or non-sc/iv prostanoids (i.e. inhaled, oral). The dose of PAH specific therapy must be stable 3 months before entering the study and should remain unchanged throughout the study.
    3. Having fulfilled his/her 18th birthday at Screening/Baseline Visit of the study but not older than 80 years (up to the patient's 81st birthday).
    4. PAH due to idiopathic pulmonary arterial hypertension or connective tissue disease associated PAH
    5. Right heart catheterisation 6 weeks prior to screening or at screening with PAH, specifically PAPm >25 mmHg (at rest), Pulmonary capillary wedge pressure (PCWP) ≤15 mmHg, pulmonary vascular resistance >500 dyn x sec x cm-5. Echocardiogram at screening consistent with PAH, specifically evidence of right ventricular hypertrophy or dilation, evidence of normal left ventricular function, and absence of mitral valve stenosis.
    6. Six minute walk distance ≥ 200m.
    7. Receiving conventional PAH therapy, stable for one month.
    8. Able to understand and willing to sign the Informed Consent Form. Written informed consent must be given before any study procedure is performed.
    1. Weibliche und männliche Patienten unabhängig ihrer ethnischen Herkunft, die an PAH leiden WHO-Funktionsklasse II-III).
    2. Patienten mit stabil eingestellter Therapie/bestmöglicher Behandlung mit Antikoagulantien, Diuretika, Herz-Glykoside, Sauerstoff-Supplementation, und Ca-Kanal-Blocker, angepasst an die individuellen Bedürfnisse des Patienten. Spezifische PAH Monotherapie (vorzugsweise mit Bosentan) oder Kombinationstherapie (mit nicht mehr als 2 spezifischen PAH Medikamenten) entweder mit Endothelin-Rezeptor Antagonisten oder Phosphodiesterase Typ 5 Inhibitoren oder nicht-sc/iv Prostanoiden (z.B. inhaliert oder oral). Die Dosierung der spezifischen PAH Medikamente muss mindestens 3 Monate vor Einschluß gleich bleibend gewesen sein und sollte im Verlauf der Studie nicht geändert werden.
    3. Vollendetes 18. Lebensjahr zu Screening/Baseline und nicht älter als 80 Jahre (vor dem 81. Geburtstag).
    4. PAH aufgrund idiopathischer pulmonaler arterieller Hypertonie oder PAH in Verbindung mit Kollagenosen.
    5. Rechtsherz-Katheter 6 Wochen vor Screening oder bei Screening mit der Diagnose PAH, im Speziellen: pulmonaler arterieller Druck (PAPm) > 25 mmHg (in Ruhe), Pulmonalkapillarenverschlussdruck (PCWP) ≤ 15 mmHg, pulmonaler Gefässwiderstand > 500 dyn x sec x cm-5. Echokardiogramm bei Screening übereinstimmend mit PAH, im Speziellen: Nachweis von Rechtsherzhypertrophie oder Dilatation, Nachweis auf normale linksventrikuläre Funktion und Abwesenheit von Mitralklappenstenose.
    6. Gehstrecke von ≥ 200 m beim 6-Minuten-Gehtest.
    7. Behandlung mit konventioneller PAH-Therapie auf stabiler Dosis für mindestens ein Monat.
    8. Fähigkeit die Patienteninformation/Einwilligungserklärung zu verstehen und zu unterschreiben. Die schriftliche Einwilligung muss erfolgt sein, bevor studienbedingte Maßnahmen durchgeführt werden.
    E.4Principal exclusion criteria
    1. PAH of any cause other than permitted in the entry criteria
    2. Contraindication for heart catheterisation
    3. Any change in conventional PAH therapy within the last month before study start
    4. Any change in PAH specific therapy within 3 months prior to study start
    5. Patients requiring intravenous prostanoid therapy within 3 month prior to study start
    6. Any subject who had received any investigational medication within 1 month prior to study start or who is
    scheduled to receive another investigational drug during the course of this study.
    7. Known intolerance to lisuride.
    8. Patients on concurrent treatment with phenylpropanolamin
    9. Active liver disease, porphyria or elevations of serum transaminases >3 x ULN (upper limit of normal) or bilirubin >
    1.5 x ULN
    10. Chronic renal insufficiency as defined by a creatinine > 2.5 mg/dL or requires dialysis
    11. Obstructive or restrictive lung disease as evidenced by pulmonary function tests within 3 months before study
    entry, showing any of the following: VC < 65% of normal value, FEV1 < 65% of normal value
    12. History of left heart disease, including any of the following: aortic or mitral valve disease, pericardial constriction,
    restrictive or congestive cardiomyopathy, left ventricular ejection fraction < 55%
    13. History of suspicion of inability to cooperate adequately
    14. Psychiatric, addictive, or other disorder that compromises the ability to participating in this study
    15. Cancer or other malignant haematological disease
    16. Pulmonary Hypertension caused by left heart disease
    17. Pulmonary Arterial Hypertension associated with congenital heart disease (PAH-CHD)
    18. Pulmonary Arterial Hypertension associated with human immunodeficiency virus infection (PAH-HIV)
    19. Portopulmonary Hypertension (PPHT)
    20. CTEPH Chronic Thromboembolic Pulmonary Hypertension
    21. Pulmonary Hypertension associated with other diseases excluding aforementioned: PAH due to idiopathic
    pulmonary arterial hypertension or connective tissue disease associated PAH including systemic sclerosis
    (sclerodermia) and systemic lupus erythematosus (SLE)
    22. Pulmonary Hypertension associated with other chronic lung diseases
    23. Patients on concurrent treatment with dopaminergic drugs
    24. Women of child bearing potential must be excluded if:
    • they have not used reliable contraception in the cycle before the study. According to CPMP/ICH/286/95
    (modification) highly effective methods of birth control (defined by a failure rate < 1% per year) include the
    consistent and correct use of implants, injectables, combined oral contraceptives, selected intrauterine devices
    (IUD), sexual abstinence or vasectomised partner. The subject has to agree to continue using such highly reliable
    contraception during the entire study period and the cycle after the study;
    • they are pregnant or lactating. (A negative pregnancy test must be provided for all women of reproductive age)
    25. Patients committed to an institution by virtue of an order issued either by the judicial or the administrative
    authorities
    1. PAH durch andere als in den Einschlusskriterien erlaubte Ursachen verursacht.
    2. Kontraindikation für die Herzkatheteruntersuchung.
    3. Jegliche Änderung der konventionellen PAH-Therapie innerhalb des letzten Monats vor Studienbeginn.
    4. Jegliche Änderung der spezifischen PAH-Therapie innerhalb der letzten 3 Monate vor Studienbeginn.
    5. Patienten, die eine intravenöse Therapie mit Prostanoiden innerhalb der letzten 3 Monate vor Studienbeginn
    benötigen.
    6. Patienten, die Studienmedikation jeglicher Art innerhalb eines Monats vor Studienbeginn erhalten haben, bzw. für
    die eine Behandlung mit einer anderen Studienmedikation im Verlauf der Studie geplant ist.
    7. Bekannte Intoleranz gegenüber Lisurid.
    8. Patienten, die gleichzeitig mit Phenylpropanolamin behandelt werden.
    9. Bestehender Leberschaden, Porphyrie oder Erhöhung der Serum-Transaminasen auf > 3 x ULN oder Bilirubin auf
    > 1.5 x ULN (ULN = Upper Limit of Normal = oberer Grenzwert).
    10. Chronische Niereninsuffizienz mit Kreatinin > 2,5 mg/dL oder dialysepflichtige Patienten.
    11. Obstruktive oder restriktive Lungenerkrankung, nachgewiesen durch einen Lungenfunktionstest innerhalb von 3
    Monaten vor Studieneintritt mit VC < 65% des Normalwerts und FEV1 < 65% des Normalwerts.
    12. Vorgeschichte von Linksherzinsuffizienz einschliesslich: Erkrankung der Aortenklappe oder Mitralklappe,
    Perikardkonstriktion, restriktive oder kongestive Kardiomyopathie, Linksventrikuläre Ejektionsfraktion < 55%
    13. Vorgeschichte oder Verdacht auf Unvermögen, angemessen zu kooperieren.
    14. Psychiatrische Störungen, Abhängigkeiten oder andere Störungen, die die Fähigkeit zur Studienteilnahme
    beeinträchtigen.
    15. Krebs oder andere maligne hämatologische Erkrankung.
    16. PAH verursacht durch Erkrankungen des linken Herzens.
    17. PAH in Verbindung mit angeborener Herzerkrankung (PAH-CHD).
    18. PAH in Verbindung mit humanem Immundefizienzvirus (PAH-HIV).
    19. Porto-pulmonale Hypertension (PPHT).
    20. Chronische thromboembolische pulmonale Hypertension (CTEPH).
    21. PAH assoziiert mit anderen Erkrankungen (außer den oben genannten): PAH infolge ideopathischer PAH oder mit
    Bindegewebserkrankunug assoziierter PAH einschließlich systemischer Sklerose (Sklerodermie) und systemischem
    Lupus Erythematosus (SLE).
    22. PAH assoziiert mit anderen chronischen Lungenkrankheiten.
    23. Patienten, die gleichzeitig mit dopaminergen Medikamenten behandelt werden
    24. Gebärfähige Frauen müssen ausgeschlossen werden, wenn:
    - sie im Zyklus vor Studienbeginn keine verläßliche Methode der Kontrazeption angewendet haben (gemäß
    CPMP/ICH/286/95 mit einer Versagerquote <1% pro Jahr).
    - sie schwanger sind oder stillen.
    25. Patienten, die aufgrund behördlicher oder gerichtlicher Anordnung in einer Anstalt untergebracht wurden.
    E.5 End points
    E.5.1Primary end point(s)
    1. Change in six minute walk distance (Baseline vs Week 26)
    2. Pulmonary vascular resistance (Baseline vs Week 26)
    3. Time from start of treatment to clinical worsening (defined as the combined end point of death, lung transplantation, hospitalisation for pulmonary hypertension, leading to discontinuation or need for additional specific PAH therapy)
    4. Change in Borg Dyspnea Index (Baseline vs Week 26)
    5. Change in WHO functional class [Baseline vs Week 26])
    6. Change in cardiac output-index
    7. Change in PA pressure
    8. Circulating levels of NT-pro-BNP (Baseline vs Week 26)
    9. Quality of life questionnaire (SF 36, [Baseline vs Week 26])
    10. Change in VO2max (Baseline vs Week 26)
    11. Adverse events
    12. Concomitant medication
    1. Änderung der 6-Minuten Gehstrecke (Baseline vs. Woche 26).
    2. Pulmonaler Gefäßwiderstand (Baseline vs. Woche 26).
    3. Zeit vom Behandlungsbeginn bis zur klinischen Verschlechterung (definiert als der kombinierte Endpunkt Tod, Lungentransplantation sowie Hospitalisierung aufgrund pulmonaler Hypertension, welche zu Studienabbruch oder zur Notwendigkeit zusätzlicher spezifischer PAH-Behandlung führt.
    4. Änderung im Borg Dyspnea Index (Baseline vs. Woche 26).
    5. Änderung in der WHO-Funktionsklasse (Baseline vs. Woche 26).
    6. Änderung im Herzzeitvolumen (Baseline vs. Woche 26).
    7. Änderung im pulmonalen arteriellen Druck (Baseline vs. Woche 26).
    8. Konzentration von NT-pro-BNP im Blut (Baseline vs. Woche 26).
    9. Fragebogen zur Lebensqualität (SF 36, Baseline vs. Woche 26).
    10. Änderung der maximalen Sauerstoffaufnahme (VO2max, Baseline vs. Woche 26).
    11. Unerwünschte Ereignisse.
    12. Begleitmedikation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After completion of week 26.
    Nach Abschluss von Woche 24.
    E.5.2Secondary end point(s)
    No secondary end points defined.
    Sekundäre Endpunkte nicht definiert.
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    nicht zutreffend
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Last visit of the last subject.
    Letzter Studienbesuch des letzten Studienpatienten.
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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.1.1.1In 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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 Yes
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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)
    Subjects will keep receiving their current standard therapy without the study medication as add-on.
    Patienten erhalten weiterhin ihre bisherige Standardbehandlung, jedoch ohne die zusätzliche Gabe von Studienmedikation.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-08-19
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