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    Summary
    EudraCT Number:2015-001962-25
    Sponsor's Protocol Code Number:BR1-142
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-05
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-001962-25
    A.3Full title of the trial
    A Prospective Multicenter Phase III Clinical Evaluation of the Safety and Efficacy of Lumason™/SonoVue® in Subjects Undergoing Pharmacologic Stress Echocardiography with Dobutamine for the Diagnosis of Coronary Artery Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lumason™/SonoVue® in Stress Echocardiography with Dobutamine for the Diagnosis of Coronary Artery Disease
    A.4.1Sponsor's protocol code numberBR1-142
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02552238
    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 SponsorBracco Imaging S.p.A.
    B.1.3.4CountryItaly
    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 supportBracco Imaging S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBracco Suisse SA
    B.5.2Functional name of contact pointGM & RA Clinical Research
    B.5.3 Address:
    B.5.3.1Street Address31, route de la Galaise
    B.5.3.2Town/ cityPlan-les-Ouates, Geneva
    B.5.3.3Post code1228
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number41228848803
    B.5.5Fax number41228848885
    B.5.6E-mailpatricia.caillon@bracco.com
    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 SonoVue®
    D.2.1.1.2Name of the Marketing Authorisation holderBracco International B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSonoVue®
    D.3.2Product code BR1
    D.3.4Pharmaceutical form Powder and solvent for dispersion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSulfur Hexafluoride
    D.3.9.1CAS number 2551-62-4
    D.3.9.3Other descriptive nameSULFUR HEXAFLUORIDE
    D.3.9.4EV Substance CodeSUB15925MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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
    Suspected or known Coronary Artery Disease
    E.1.1.1Medical condition in easily understood language
    Suspected or known Coronary Artery Disease
    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 HLGT
    E.1.2Classification code 10011082
    E.1.2Term Coronary artery disorders
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objectives:
    To assess the efficacy of SonoVue®-enhanced dobutamine stress echocardiography (DSE) in subjects with suspected or known CAD having suboptimal left ventricular (LV) endocardial border delineation (EBD) at unenhanced echocardiography in terms of:
    - Sensitivity and specificity for the detection or exclusion of CAD in unenhanced versus SonoVue®-enhanced DSE using coronary angiography or clinical follow-up as the truth standard;
    - Critical shift from suboptimal (≥2 adjacent segments inadequate on any apical view) at unenhanced dobutamine stress echocardiography (UE-DSE) to adequate images (reduction of suboptimal adjacent segments) for LV EBD at contrast-enhanced dobutamine stress echocardiography (CE-DSE).
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    - Change from peak stress non-contrast ultrasound (UE-DSE) versus peak stress contrast-enhanced ultrasound (CE-DSE) in total LV EBD score.
    - To obtain safety data in subjects undergoing DSE with SonoVue®.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Provides written Informed Consent and is willing to comply with protocol requirements;
    - Is at least 18 years of age;
    - Has suspected or known CAD and is scheduled to undergo coronary angiography within 6 months after the SonoVue® DSE.
    - Has undergone a previous echocardiography prior to enrollment; resulting in suboptimal unenhanced images at rest, defined as ≥ 2 suboptimal adjacent segments in any apical view.
    E.4Principal exclusion criteria
    - Is a pregnant or lactating female. Exclude the possibility of pregnancy:
    by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the start of SonoVue®
    administration(s),
     by surgical history (e.g., tubal ligation or hysterectomy),
     post menopausal with a minimum 1 year without menses;
    - Has any known hypersensitivity to 1 or more ingredients of SonoVue® (sulfur hexafluoride or to any components of SonoVue®);
    - Has any known hypersensitivity to dobutamine;
    - Has an ongoing or recent (within the last 30 days) acute myocardial infarction;
    - Has known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated saline study performed before administration of SonoVue®);
    - Has electrolyte (especially potassium and magnesium) abnormalities;
    - Has unstable pulmonary and/or systemic hemodynamic conditions e.g.:
     decompensated or inadequately controlled congestive heart failure (NYHA Class IV);
     hypovolemia;
     uncontrolled hypertension, i.e. resting systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg;
     unstable angina;
     acute coronary syndrome;
     aortic dissection;
     acute pericarditis, myocarditis, or endocarditis;
     stenosis of the main left coronary artery
    hemodynamically significant outflow obstruction of the left ventricle, including hypertrophic obstructive
    cardiomyopathy;
     hemodynamically significant cardiac valvular defect;
     acute pulmonary embolism;
    - Has uncontrolled cardiac arrhythmias;
    - Has significant disturbance in conduction;
    - Has hypertrophic subaortic stenosis;
    - Has an acute illness (e.g., infections, hyperthyroidism, or severe anemia);
    - Was previously entered into this study or received an investigational compound within 30 days before admission into this study;
    - Has been treated with any other contrast agent either intravascularly or orally within 48 hours of the first SonoVue® administration;
    - Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations;
    E.5 End points
    E.5.1Primary end point(s)
    Primary endoint:
    Sensitivity and specificity for detection and exclusion of CAD:
    • CE-DSE is superior to UE-DSE for at least 2 out of the 3 blinded readers and for the same 2 readers a lower limit of 2-sided 95% CI for sensitivity/specificity is ≥ 50% (a rate considered greater than chance);

    Co-Primary endpoint:
    Critical shift of subjects with suboptimal images at UE-DSE to adequate images at CE-DSE:
    • For at least 2 out of the 3 blinded readers lower limit of 2-sided 95% CI is above 35%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the blinded reading
    E.5.2Secondary end point(s)
    Change in total LV EBD scores at peak stress from UE-DSE to CE-DSE.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the blinded reading
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    Netherlands
    United Kingdom
    United States
    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
    The end of the study is defined as the last subject’s image review conducted by the off-site blinded assessor(s).
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 2015-11-05. 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 175
    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)
    Not applicable as the investigational medicinal product is only used for diagnostic purposes.
    However, patients who discontinue the study prematurely will be further treated by their physician in accordance with the clinical routine of the respective site.
    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 Decision2015-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-25
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