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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

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    Summary
    EudraCT Number:2012-002678-29
    Sponsor's Protocol Code Number:BMS747158-302
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2012-12-27
    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 ConcernedFinland - Fimea
    A.2EudraCT number2012-002678-29
    A.3Full title of the trial
    A Phase 3, Open-Label, Multicenter Study for the Assessment of Myocardial Perfusion using Positron Emission Tomography (PET) Imaging of Flurpiridaz F 18 Injection in Patients with Suspected or Known Coronary Artery Disease (CAD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to be conducted in many countries in patients who are known or believed to have a harmful build-up of substances in the arteries that supply blood to the heart to assess whether images that show how a test compound, flurpiridaz F 18 injection, is distributed within the heart can be used by Doctors to determine if there is such a harmful build-up
    A.3.2Name or abbreviated title of the trial where available
    None
    A.4.1Sponsor's protocol code numberBMS747158-302
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01681524
    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 SponsorLantheus Medical Imaging, Inc.
    B.1.3.4CountryUnited States
    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 supportLantheus Medical Imaging, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLantheus MI (UK) Limited
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressFestival House, 39 Oxford Street
    B.5.3.2Town/ cityNewbury
    B.5.3.3Post codeRG14 1JG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004401635573553
    B.5.5Fax number004401635581584
    B.5.6E-mailinfo@wmjconsulting.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 No
    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 nameFlurpiridaz F 18 injection
    D.3.2Product code BMS747158
    D.3.4Pharmaceutical form Solution 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 INNNot applicable
    D.3.9.1CAS number 863887-89-2
    D.3.9.2Current sponsor codeBMS747158-02
    D.3.9.3Other descriptive nameRP1012-18, [18F]-RP1012
    D.3.10 Strength
    D.3.10.1Concentration unit mCi millicurie(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.0
    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 Yes
    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
    Assessment of myocardial perfusion using Positron Emission
    Tomography (PET) Imaging of Flurpiridaz F 18 Injection in patients with suspected or known coronary artery disease.
    E.1.1.1Medical condition in easily understood language
    Imaging of the heart in patients with a disease of the artery or had a heart attack to see if there is a build up of harmful substances inside the arteries that supply blood to the heart.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10068617
    E.1.2Term Coronary heart disease
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to assess the diagnostic efficacy (sensitivity and specificity) of flurpiridaz F 18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed
    tomography (SPECT) MPI in the detection of significant coronary artery disease (CAD) as defined by cardiac catheterization (CC) or a documented history of myocardial infarction (MI).
    E.2.2Secondary objectives of the trial
    •Diagnostic performance characteristics of flurpiridaz F 18 injection PET MPI compared to SPECT MPI for identifying the location of significant CAD
    • Diagnostic performance characteristics of flurpiridaz F 18 injection PET MPI compared to SPECT MPI for identifying multivessel CAD
    • Diagnostic efficacy of flurpiridaz F 18 injection PET MPI compared to SPECT MPI in the detection of significant CAD in specific population subgroups:
    • Patients undergoing pharmacologic stress
    • Female patients
    • Patients with a BMI ≥ 30
    • Image quality of rest and stress flurpiridaz F 18 injection PET MPI as compared to SPECT MPI
    • Diagnostic certainty of rest and stress flurpiridaz F 18 injection PET MPI as compared to SPECT MPI
    • Reversible defect size (extent and severity) of rest and stress flurpiridaz F 18 injection PET MPI compared to SPECT MPI
    • Safety of flurpiridaz F 18 injection PET MPI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women ≥18 years of age.
    2. Have been scheduled via written documentation to undergo CC at the time of enrollment, or have undergone prior CC without intervention (being either positive or negative for the presence of CAD).
    3. Have undergone a clinically-indicated SPECT which meets all study-specified imaging and stress testing criteria, or the patient is willing to undergo SPECT MPI for the purposes of the clinical study.
    4. Be capable of undergoing exercise or pharmacologic stress as described in protocol.
    5. Have provided Informed Consent (IC) prior to undergoing any study procedures.
    E.4Principal exclusion criteria
    1. Female patients who are pregnant or lactating. (All women of child bearing potential [WOCBP] must have a negative serum pregnancy test at screening and within 36 hours prior to start of investigational product administration [predose] regardless of contraceptive use history).
    2. Women of child-bearing potential are excluded unless they:
    a. are post-menopausal defined as amenorrhea ≥ 24 consecutive months
    or
    b. have undergone successful surgical sterilization or
    c. have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 3 months prior to flurpiridaz F 18 injection dose administration and be willing to continue using the same method for the duration of the study.
    3. Current illness or pathology that poses a significant safety risk for the patient to undergo investigational product administration and/or cardiac stress testing.Such as:
    a. uncontrolled symptomatic or New York Heart Association Class III or IV congestive heart failure within 48 hours prior to screening or inability to lie flat for the duration of imaging.
    b. symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease without suspected or known CAD
    4. Arterial hypertension or arterial hypotension on 2 consecutive readings within 1 hour prior to flurpiridaz F 18 administration.
    5.Patients who are clinically incapable of tolerating a stress test as a result of their coronary status. Patients with unstable cardiovascular status excluded from enrollment are :
    a. myocardial infarction or unstable angina pectoris within 6 months prior to dose administration of flurpiridaz F 18 injection
    b. transient ischemic attack (TIA) or stroke within 3 months prior to dose administration of flurpiridaz F 18 injection
    c. clinically significant congenital heart defects.
    d. current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
    e. acute pulmonary embolus or pulmonary infarction
    f. acute myocarditis or pericarditis
    g. acute aortic dissection
    6. History of CABG surgery
    7. PCI within 6 months prior to administration of flurpiridaz F 18 injection
    8. Current non-ischemic (dilated, hypertrophic, or restrictive) cardiomyopathy that has contraindications to stress testing and/or without known or suspected CAD
    9. Currently scheduled for a heart transplant or has a history of heart transplantation
    10. Any major surgery within 4 weeks prior to screening
    11. Any major surgery planned within 14-17 days following the 2-week telephone follow-up assessment (with the exception of scheduled CABG or other surgical treatment of the underlying cardiovascular disease) (Note: Patients undergoing noninvasive or superficial surgery with a mortality rate of <1% are considered low risk and are NOT excluded from this study.)
    12. Participation in any investigational study (including drug, device, or placebo studies) within 30 days prior to screening or 2 weeks past any BMS747158-302 study-related procedures
    13. Participation in any prior study with flurpiridaz F 18 injection
    14. Prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (eg, infectious disease)
    15. Known or suspected severe or acute hepatic failure or under evaluation for liver transplantation
    16. Known severe renal disease (glomerular filtration rate [GFR] < 29 mL/min/1.73 m2) or undergoing renal dialysis
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of the study are the sensitivity and specificity of flurpiridaz F 18 injection PET MPI compared to SPECT MPI with respect to the truth standard. The truth standard used in this study is the presence of CAD (ie, disease-positive) as evidenced by the following:
    • QCA reveals the presence of stenosis of ≥50% in ≥1 coronary artery, OR
    • There is a history of MI as documented by:
    1. A wall motion abnormality by echocardiography (ie, hypokinesis, akinesis, or dyskinesis) at least 1 month after the acute syndrome as assessed by an independent echocardiographic core laboratory
    AND
    2. Either a history of acute coronary syndrome with elevated cardiac enzymes/troponin OR the presence of pathological Q waves.

    An adjudication committee will review all prior MI history, including ECGs and echocardiography results.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The data used for the image reads are captured at least 30 minutes after drug administration

    E.5.2Secondary end point(s)
    Diagnostic performance characteristics of flurpiridaz F 18 injection PET MPI compared to SPECT MPI for identifying the location of significant CAD,for identifying multivessel CAD, and in patient subgroups.

    Image quality and diagnostic certainty of flurpiridaz F 18 injection PET MPI compared to SPECT MPI.

    Defect size (extent and severity) of flurpiridaz F 18 injection PET MPI compared to SPECT MPI
    E.5.2.1Timepoint(s) of evaluation of this end point
    The data used for the image reads are captured at least 30 minutes after drug administration

    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Comparator study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Comparison with SPECT MPI
    E.8.2.4Number of treatment arms in the trial2
    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 EEA20
    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
    Brazil
    Canada
    France
    Italy
    Switzerland
    United States
    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
    LVLS - the date on which last required image is
    acquired which can be no later than Day 60 for the last patient.
    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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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.1.2.1Number of subjects for this age range: 372
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects with diminished capacity
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 672
    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)
    Normal treatment for this condition will continue for all subjects.
    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 Decision2013-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-08
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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