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    Summary
    EudraCT Number:2010-022820-61
    Sponsor's Protocol Code Number:Tad-10
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-12-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-022820-61
    A.3Full title of the trial
    PHASE CONTRAST MAGNETIC RESONANCE (MR) IMAGING IN MONITORING THE EFFECTS OF TADALAFIL IN PATIENTS WITH OUT-OF-PROPORTION PULMONARY HYPERTENSION AND LEFT VENTRICULAR DYSFUNCTION
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberTad-10
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    B.1.3.4CountryItaly
    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 organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTadalafil
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Hypertension ``out-of-proportion`` associated to moderate left ventricular dysfunction
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10037406
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    TO EVALUATE THE HEMODYNAMIC EFFECT OF 6 MONTHS TADALAFIL ADMINISTRATION ON THE IMPROVEMENT OF PULMONARY VASCULAR RESISTANCE (pvr) ESTIMATION BY RIGHT HEART CATHETERIZATION IN OUT-OF-PROPORTION PULMONARY HYPERTENSION (PH) ASSOCIATED TO MODERATE LEFT VENTRICULAR DYSFUNCTION (A SUB-GROUP OF THE 2� CATEGORY OF THE WHO CLINICAL CLASSIFICATION SYSTEM-VENICE 2003 REVISION)
    E.2.2Secondary objectives of the trial
    - evaluation of the effect of 6 months treatment with tadalafil on the right heart remodelling, measuring the changes in Ventricular Mass (VM), Ventricular Volume (VV), VM/VV ratio, Ejection Fraction (EF), intraventricular asynchrony by MRI; - evaluation of the effect of 6 months treatment with Tadalafil on hemodynamic parameters: Cardiac Index (L/min/m2) and mean right atrial pressure (RAPm), mean pulmonary arterial pressure (PAPm), Pulmonary wedge Pressure (PWP), mean aortic pressure (PAom) by catheterization; - improvement in effort capacity: 6-Minutes Walking Test (6MWT) - to assess the changes in endothelial function parameters: endothelin 1, sCRP, cGMP, atrial and brain natriuretic peptide (ANP - BNP) and cytokines (IL1, IL6, TGF beta, TNF alfa, VEGF, VCAM)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    patients aged > 18 yrs with out-of-proportion hypertension associated to moderate left ventricular dysfunction (a subgroup of the 2� category of the WHO clinical classification system Venice 2003 ervision) NYHA class IIa referred to pulmonary hypertension center for evaluation. - moderate left ventricular dysfunction is defined as left ventricular ejection fraction between 35 and 45% - pulmonary hypertension out-of-proportion associated to left ventricular dysfunction is defined as mean mean pulmonary arterial pressure (PAP ≥ 40-45 mmHg and a transpulmonary pressure gradient (mean PAP- mean pulmonary wedge pressure –PWP) > 12 mmHg (ESC-ERS Guidelines 2009)
    E.4Principal exclusion criteria
    Exclusion criteria will be idiopatic pulmonary hypertension and pulmonary hypertension secondary to chronic obstructive or restrictive pulmonary disease, recurrent pulmonary embolism, pulmonary venous congestion, acute or chronic inflammatory lung disease, pregnancy or insufficient contraceptive measures, and previous treatment with PDE inhibitors and contraindication to assumption of PDE5i (patients with hepatic or renal insufficiency and known retinal disease) and concomitant use of nitrate. Hypersensitivity to the active substance or to any of the excipients. Acute myocardial infarction within the last 90 days. Severe hypotension (<90/50 mm Hg). Patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure. Patients with clinically significant aortic and mitral valve disease. Patients with pericardial constriction. Patients with restrictive or congestive cardiomyopathy . Patients with significant left ventricular dysfunction. Patients with life-threatening arrhythmias. Patients with symptomatic coronary artery disease . Patients with uncontrolled hypertension. Pulmonary veno-occlusive disease (PVOD). Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Objective: to evaluate the hemodynamic effect of 6 months Tadalafil administration on the improvement of Pulmonary Vascular Resistance (PVR) estimation by right heart Catheterization.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    validare una metodica diagnostica meno invasiva
    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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) Yes
    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 state25
    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 Decision2010-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-14
    P. End of Trial
    P.End of Trial StatusOngoing
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