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    Summary
    EudraCT Number:2011-005440-98
    Sponsor's Protocol Code Number:
    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:2012-03-07
    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 number2011-005440-98
    A.3Full title of the trial
    Double blinded randomised trial for the evaluation of the effectiveness of
    prophylactic use of sildenafil for the prevention of pulmonary
    hypertensive crisis after congenital heart surgery
    Doppelblinde randomisierte Studie zur Evaluierung der Wirksamkeit der
    prophylaktischen Gabe von Sildenafil zur Verhinderung von pulmonal
    hypertensiven Krisen nach Operation angeborener Herzfehler
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Examination of the effectiveness of sildenafil in preventing lung vessel
    constriction after heart surgery in children
    Untersuchung der Wirksamkeit von Sildenafil zur Verhinderung von
    Lungenhochdruck nach Herzoperationen im Kindesalter
    A.3.2Name or abbreviated title of the trial where available
    Sildenafilstudy
    Sildenafilstudie
    A.4.1Sponsor's protocol code number
    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 SponsorAKH Linz
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAKH Linz
    B.5.2Functional name of contact pointAnaesthesie
    B.5.3 Address:
    B.5.3.1Street AddressKrankenhausstrasse 9
    B.5.3.2Town/ cityLinz
    B.5.3.3Post code4020
    B.5.4Telephone number004373278062158
    B.5.5Fax number004373278062154
    B.5.6E-mailanna.hofer@akh-linz.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 Revatio 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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 nameRevatio 20 mg
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameSildenafil
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboGastroenteral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ventriculs septal defect, atrioventricular canal with pulmonary
    hypertension
    Ventrikelseptumdefekt, AV-Kanal mit pulmonaler Hypertonie
    E.1.1.1Medical condition in easily understood language
    Heart defects with elevated lung vessel pressure
    Herzscheidewanddefekte mit 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 HLT
    E.1.2Classification code 10010401
    E.1.2Term Congenital cardiovascular anomaly therapeutic procedures
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Frequency of pulmonary hypertensive crises
    Häufigkeit von Lungenhochdruckkrisen
    E.2.2Secondary objectives of the trial
    mean pulmonary artery pressure
    cardiac output by transoesophageal Doppler
    fluid balance
    length of ventilation
    length of ICU stay
    mittlerer Pulmonalarteriendruck
    Herzzeitvolumen bestimmt mit transoesophagealem Doppler
    Flüssigkeitsbilanz
    Beatmungsdauer
    Intensivaufenthaltsdauer
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Ventricular septal defect, AV-Canal with pulmonary hypertension
    informed parental consent
    age 0-2 years
    Ventrikelseptumdefekt, AV-Kanal mit pulmonaler Hypertonie
    Einwilligung der Eltern
    Alter 0-2 Jahre
    E.4Principal exclusion criteria
    additional structural abnormalities affecting pulmonary resistance
    ventilation preoperatively
    residual VSD
    high dosage of catecholamines, hemodynamic instability
    extracorporeal technics
    abnormalities of oesophagus with contraindication for transoesophegeal
    Doppler
    Widerstand beeinflussen
    Beatmung präoperativ
    Rest-VSD postoperativ
    hoher Katecholaminbedarf und hämodynamische Instabilität
    extrakorporale Verfahren wie ECMO oder Peritonealdialyse
    orofaziale oder Ösophagusmißbildungen, die eine Bestimmung des HZV
    mit transösophagealem Doppler ausschließen
    E.5 End points
    E.5.1Primary end point(s)
    number of pulmonary hypertensive crises
    Anzahl pulmonal hypertensiver Krisen
    E.5.1.1Timepoint(s) of evaluation of this end point
    0,6,12,24,36,48 hours after admission
    0,6,12,24,36,48, Stunden nach Intensivaufnahme
    E.5.2Secondary end point(s)
    mean pulmonary pressure
    fluid balance
    cardiac output
    duration of ventilation
    duration of ICU stay
    German
    mittlerer Pulmonalarteriendruck
    Flüssigkeitsbilanz
    Herzzeitvolumen
    Beatmungsdauer
    Intensivaufenthaltsdauer
    E.5.2.1Timepoint(s) of evaluation of this end point
    0,6,12,24,36,48 hours after admission
    0,6,12,24,36,48, Stunden nach Intensivaufnahme
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    last visit of the last subject
    letzte Visite letzter Patient
    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
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 40
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 40
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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)
    according to local standards
    entsprechend der lokalen Standards
    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 Decision2012-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-19
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