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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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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.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

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    Summary
    EudraCT Number:2015-000709-38
    Sponsor's Protocol Code Number:BBR
    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:2015-07-28
    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 number2015-000709-38
    A.3Full title of the trial
    Acute Effects of Benzbromaron on the pulmonary circulation
    Akute Effekte von Benzbromaron auf die pulmonale Zirkulation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of the drug Benzbromaron on the pulmonary vessels
    Die Wirkungen des Medikamentes Benzbromaron auf die Lungengefäße
    A.4.1Sponsor's protocol code numberBBR
    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 SponsorMedical University of Graz
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedical University of Graz
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportLudwig Boltzmann Institute for Lung Vascular Research
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Graz
    B.5.2Functional name of contact pointDepartment for Pulmonology
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 20
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number4331638512183
    B.5.6E-mailgabor.kovacs@klinikum-graz.at
    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 Benzbromaron AL
    D.2.1.1.2Name of the Marketing Authorisation holderALIUD PHARMA® GmbH & Co. KG
    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 nameBenzbromaron
    D.3.4Pharmaceutical form Film-coated 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 INNBENZBROMARONE
    D.3.9.1CAS number 3562-84-3
    D.3.9.4EV Substance CodeSUB05743MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Pulmonal arterielle Hypertonie
    E.1.1.1Medical condition in easily understood language
    elevated pulmonary blood pressure
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to assess the change of pulmonary vascular resistance 2 hours after the application of 200mg benzbromaron
    Messung der Änderung des pulmonalen Gefäßwiderstandes 2 Stunden nach der einmaligen Gabe von Benzbromaron 200mg per os
    E.2.2Secondary objectives of the trial
    to assess the change of mean pulmonary arterial pressure, systemic blood pressure and oxygen saturation 2 hours after the application of 200mg benzbromaron
    Messung der Änderung des mittleren pulmonalen Drucks, des systemischen Drucks sowie der Oxygenierung nach der einmaligen Gabe von Benzbromaron 200mg per os
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    informed consent
    diagnosis of pulmonary arterial hypertension
    age: 18-90 years
    Medically indicated right heart catheterization
    • Schriftliche Einwilligung
    • PatientInnen mit gesicherter pulmonal arterieller Hypertonie
    • Alter: 18 – 90 Jahre
    • Medizinisch indizierte Rechtsherzkatheter Untersuchung
    E.4Principal exclusion criteria
    known allergy against benzbromaron, gelborange S or another component of the drug or against a drug with similar chemical structure
    decreased renal function (GFR<60ml/min/kg)
    renal diathesis
    severe lilver disease (Bilirubin >1.6 mg% or AST or ALT > 3x ULN)
    known pregnancy
    uncontrolled systemic arterial hypertension (at rest >150 mmHg systolic or 95 mmHg diastolic)
    uncontrolled ventricular arrythmias
    uncontrolled bradycard or tachycard supraventricular arrythmias
    myicardial infarction in the last 12 months
    acute pulmonary embolism in the last 6 months
    ongoing iv or sc Prostanoidtherapy for pulmonary arterial hypertension
    • Überempfindlichkeit gegenüber Benzbromaron, Gelborange S oder einem der sonstigen Bestandteile oder gegenüber Medikamenten mit ähnlicher chemischer Struktur
    • eingeschränkte Nierenfunktion (GFR<60ml/min/kg)
    • Nierensteindiathese.
    • vorbestehende schwere Lebererkrankungen (Bilirubin >1.6 mg% oder AST oder ALT > 3x über Norm)
    • Schwangerschaft (anamnestisch erhoben)
    • Unkontrollierte systemisch arterielle Hypertonie (Ruhe >150 mmHg systolisch oder 95 mmHg diastolisch)
    • Unkontrollierte ventrikuläre Herzrhythmusstörungen
    • Unkontrollierte bradykarde oder tachykarde supraventrikuläre Rhythmusstörungen
    • Myokardinfarkt in den letzten 12 Monaten
    • Lungenarterienembolie in den letzten 6 Monaten
    • laufende iv. oder sc. Prostanoidtherapie für die PAH
    E.5 End points
    E.5.1Primary end point(s)
    change in pulmonary vascular resistance
    Pulmonale Gefäßwiderstandsänderung
    E.5.1.1Timepoint(s) of evaluation of this end point
    before the application of benzbromaron and two hours after benzbromaron
    vor und 2 Stunden nach Benzbromarongabe
    E.5.2Secondary end point(s)
    mean pulmonary arterial pressure, systemic blood pressure and oxygen saturation
    mittlerer pulmonaler Druck, systemischer Druck, Oxygenierung
    E.5.2.1Timepoint(s) of evaluation of this end point
    before the application of benzbromaron and two hours after benzbromaron
    vor und 2 Stunden nach Benzbromarongabe
    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 No
    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
    LVLS
    Letzter Besuch des letzten Teilnehmers
    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 months0
    E.8.9.1In the Member State concerned 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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-07-28. Yes
    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 state10
    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)
    standard therapy
    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 Decision2015-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-23
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