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    Summary
    EudraCT Number:2015-002835-17
    Sponsor's Protocol Code Number:250774
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2015-11-26
    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 number2015-002835-17
    A.3Full title of the trial
    Investigation of the influence of PAH-specific medication on right ventricular function in patients with pulmonary arterial hypertension (PAH) under basal conditions
    Untersuchung des Einflusses PAH-spezifischer Medikation auf die rechtsventrikuläre Funktion bei Patienten mit pulmonaler arterieller Hypertonie (PAH) unter basalen Bedingungen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RIGHT HEART III Study – Right ventricular hemodynamic evaluation and response to treatment
    Untersuchung des Einflusses PAH-spezifischer Medikation auf die Kraft des rechten Herzens bei Patienten mit pulmonaler arterieller Hypertonie (PAH) unter normalen Bedingungen sowie unter dem Einfluss der Medikation.
    A.3.2Name or abbreviated title of the trial where available
    RIGHT HEART III
    A.4.1Sponsor's protocol code number250774
    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 SponsorJustus Liebig Universität Gießen
    B.1.3.4CountryGermany
    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 supportJustus Liebig Universität Gießen
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniklinik Gießen und Marburg Standort Gießen
    B.5.2Functional name of contact pointMedizinische Klinik II
    B.5.3 Address:
    B.5.3.1Street AddressKlinikstr. 33
    B.5.3.2Town/ cityGiessen
    B.5.3.3Post code35392
    B.5.3.4CountryGermany
    B.5.4Telephone number0049641985 42352
    B.5.5Fax number 0049641985 56766
    B.5.6E-mailKhodr.Tello@innere.med.uni-giessen.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 Adempas®
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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 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 INNRIOCIGUAT
    D.3.9.1CAS number 625115-55-1
    D.3.9.4EV Substance CodeSUB32880
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number7,5
    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 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 Opsumit®
    D.2.1.1.2Name of the Marketing Authorisation holderActelion Registration Ltd
    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 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 INNMACITENTAN
    D.3.9.1CAS number 441798-33-0
    D.3.9.4EV Substance CodeSUB89247
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 (PAH)
    Pulmonale arterielle Hypertonie (PAH)
    E.1.1.1Medical condition in easily understood language
    Pulmonary arterial Hypertension
    Lungenhochdruck
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10037403
    E.1.2Term Pulmonary hypertension NOS
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077729
    E.1.2Term Pulmonary arterial hypertension WHO functional class III
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077740
    E.1.2Term Pulmonary arterial hypertension WHO functional class II
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigation of the therapeutic effect of both groups as measured by the change in systolic and diastolic RV function within 12 weeks after starting medication to plan a larger Phase II study.
    Ermittlung des Therapieeffektes beider Gruppen gemessen an der Veränderung der systolischen und diastolischen RV-Funktion innerhalb von 12 Wochen nach Beginn der Medikamenteneinnahme zur Planung einer größeren Phase II Studie.


    E.2.2Secondary objectives of the trial
    Recruiting
    feasibility
    procentual Right ventricular contractility (end-systolic elastance = Ees) from baseline to 12 weeks
    Arterial elastance (Ee)
    Ratio Ees/Ea
    Maximum and minimum increase in right ventricular pressure curve
    Diastolic right ventricular function (Tau, EDPVR)
    Diastolic RV function via the fibrosis degree in MRT using late enhancement, T1 mapping
    preload recruitable stroke work, (PRSW)
    Swan-Ganz measurement: Heart-time volume, venous oxygen saturation, pulmonary arterial pressure, pulmonary capillary wedge pressure.
    EDV, ESV, SV, EF, strain Analysis of RV (not obligatory), RV and LV mass, RV EDV / LV EDV, Late enhancement
    Stiffness of the pulmonary artery, capacity of the pulmonary artery, elastance of the pulmonary artery, total power, oscillatory power, mean power
    EDP (end-diastolic pressure), ESP (endsystolic pressure)
    Heart rate
    Starling contractility-index
    6-Minute Walk Test
    lung function
    Acquisition of Adverse Events
    Rekrutierbarkeit
    Durchführbarkeit
    Prozentuale Änderung der RV-Kontraktilität (= endsystolische Elastance, Ees) zwischen Baseline und 12 Wochen
    RV-Kontraktilität (Ees)
    arterielle Elastance (Ea)
    Verhältnis Ees/Ea
    maximale bzw. minimale Steigerung der rechts-ventrikulären Druckkurve [(dp/dt) max und min],
    diastolische RV-Funktion (Tau, EDPVR)
    diastolische RV-Funktion über den Fibrosegrad im MRT mittels late-enhancement, T1-Mapping
    Druckabhängige Herzarbeit
    Swan-Ganz-Messwerte: Herz-Zeit-Volumen, venöse Sauerstoffsättigung, pulmonal-arterieller Druck, pulmonal-kapillärer Verschlussdruck.
    EDV, ESV, SV, EF, strain Analyse des RV (nicht obligat), RV- und LV-Masse, RV EDV/LV EDV, Late enhancement
    Stiffness, Capacity und Elastance der Pulmonalarterie, Total power, oscillatory power, mean power
    EDP (enddiastolischer Druck), ESP (endsystolischer Druck)
    Herzfrequenz
    Starling-contractility-index
    6-Minuten-Gehtest
    Lungenfunktion
    Erfassung der Adverse Events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Man or woman 18 to 85 years of age
    - Invasive confirmed diagnosis of pulmonary hypertension, group 1 according to the Nice Classificationto (PAH), WHO Functional Classes II and III
    - Clinical need to perform onece more the right heart catheterization, (according to the recommendation of the current Cologne Consensus Conference)
    - Ability to understand the study information and study objectives
    - Hemodynamic criteria: will be measured during right heart catheter examination: pulmonary vascular resistance (PVR) > 240dyn x sec x cm-5, mean pulmonary arterial pressure (mPAP) ≥ 25mmHg
    - For clinical reasons, need to receive an approved drug for the treatment of PAH
    - Potentially child-bearing women must be able to practice highly effective methods of contraception, either by abstinence or by using at least two methods of gestational contraception from the date of consent to one month after the end of the study. Effective pregnancy protection consists of the combination of a hormonal contraceptive (oral, injectable or implant) and a barrier method (condom or diaphragm with a vaginal spermicide)
    - Signed informed consent form by the patient according to local regulations
    - Weibliche und männliche Probanden, 18 Jahre ≤ Alter ≤ 85 Jahre
    - Invasive gesicherte Diagnose einer Pulmonalen Hypertonie Gruppe 1 nach Nizza Definition (PAH), WHO Funktionsklassen II und III
    - Bestehende klinische Notwendigkeit erneut eine Rechtsherzkatheter-Untersuchung durchzuführen (laut Empfehlung der jeweils aktuellen Kölner Konsensuskonferenz)
    - Fähigkeit die Studienaufklärung- und Studienziele zu verstehen und diesen zuzustimmen
    - Hämodynamische Kriterien: Folgende während einer Rechtsherzkatheter-Untersuchung gemessene Werte:
    - Pulmonal-vaskulärer Widerstand (PVR) > 240dyn x sec x cm-5
    - mittlerer pulmonal-arterieller Druck (mPAP) ≥ 25mmHg
    - Aus klinischen Gründen bestehende Notwendigkeit, erstmals eine Behandlung mit einem für die Therapie der PAH zugelassenen Medikament zu erhalten
    - Potentiell gebärfähige Frauen müssen einverstanden sein, hochwirksame Methoden der Empfängnisverhütung zu praktizieren, entweder durch Abstinenz oder durch die Verwendung von mindestens zwei Methoden der Schwangerschaftsverhütung ab dem Datum der Zustimmung bis ein Monat nach Ende der Studie. Ein effektiver Schwangerschaftsschutz besteht in der Kombination von einem hormonellen Verhütungsmittel (oral, injizierbar oder Implantat) und einer Barrieremethode (Kondom oder Diaphragma mit einem vaginalen Spermizid)
    - Einwilligung in die klinische Studie
    E.4Principal exclusion criteria
    - Treatment with positive inotropic drugs e.g. Catecholamine (incl. Noradrenaline, Dobutamin, Suprarenin)
    - Pregnancy or breastfeeding
    - General contraindications to perform scheduled examinations during the study
    - Hypersensitivity to the active substances or to a component of the study drugs (in particular lactose and soya)
    - Simultaneous participation in another drug therapy study,
    - Simultaneous participation in another non-drug study, which would oppose participation in this study
    - Participation within one month after completion of another therapy study
    - Severe hepatic impairment
    - Existing increase in liver aminotransferase values (aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT))> 3 × ULN
    - Systolic blood pressure <95 mmHg at the beginning of treatment
    - Pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)
    - anemia (Hb <10 g / dl)
    - Accompanying medication with potential interaction with macitentan and riociguat in accordance with the relevant information of the specialist information
    - Severe renal impairment
    - Severe hemoptysis
    - Bronchial artery embolisation in prehistory
    - Smokers


    - Bestehende Therapie mit positiv inotropen Medikamenten wie z.B. Catecholaminen (u.a. Noradrenalin, Dobutamin, Suprarenin)
    - Schwangerschaft oder Stillzeit
    - Allgemeine Kontraindikation für die Durchführung der Untersuchung im Rahmen der Studie
    - Überempfindlichkeit gegenüber den Wirkstoffen oder einem Bestandteil der Studienmedikamente (insbesondere Lactose und Soja)
    - Gleichzeitige Teilnahme an einer anderen medikamentösen Therapiestudie,
    - Gleichzeitige Teilnahme an einer anderen nicht-medikamentösen Studie, welche einer Teilnahme an dieser Studie entgegenstehen würde
    - Teilnahme innerhalb eines Monats nach Beendigung einer weiteren Therapiestudie
    - Schwerere Leberfunktionsstörungen
    - Bestehende Erhöhung der Leber-Aminotransferasewerte (Aspartat-Aminotransferase (AST) und/oder Alanin-Aminotransferase (ALT)) > 3 × ULN
    - Systolischer Blutdruck < 95 mmHg bei Behandlungsbeginn
    - Pulmonale Hypertonie verbunden mit idiopathischen interstitiellen Pneumonien (PH-IIP)
    - Anämie (Hb <10 g/dl)
    - Begleitmedikation mit potentieller Interaktion zu Macitentan und Riociguat gemäß den entsprechenden Angaben der Fachinformationen
    - Schwere Nierenfunktionsstörungen
    - Schwerwiegende Hämoptoe
    - Bronchialarterienembolisation in der Vorgeschichte
    - Raucher



    E.5 End points
    E.5.1Primary end point(s)
    please see E.2 Objectives of the Trial
    please see E.2 Objectives of the Trial
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 Wochen
    E.5.2Secondary end point(s)
    please see E.2 Objectives of the Trial
    please see E.2 Objectives of the Trial
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 Wochen
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Pilotstudy to investigate feasibility of a bigger Phase II trial
    Pilotstudie zur Überprüfung der Machbarkeit einer größeren Phase II Studie
    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 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 No
    E.8.2.4Number of treatment arms in the trial2
    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 and database closure
    Letzter Patient, letzte Visite und Datenbankschluss
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days29
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    Patients will be treated according to clinical routine.
    Die Patienten werden gemäß der klinischen Routine behandeln.
    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 Decision2016-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-22
    P. End of Trial
    P.End of Trial StatusRestarted
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