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    Summary
    EudraCT Number:2011-001245-32
    Sponsor's Protocol Code Number:PGX-III-AP-002
    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:2011-06-28
    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 number2011-001245-32
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind Trial of Apadenoson for the Detection of Myocardial Perfusion Defects Using Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a trial of apadenoson, an investigational drug, for the detection of Myocardial Perfusion Defects using Single Photon Emission Computed Tomography Myocardial Perfusion Imaging (SPECT-MPI).
    A.3.2Name or abbreviated title of the trial where available
    ASPECT-2
    A.4.1Sponsor's protocol code numberPGX-III-AP-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01313572
    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 SponsorForest Laboratories, 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 supportForest Laboratories, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationForest Research Institute, a subsidiary of Forest Laboratories, Inc.
    B.5.2Functional name of contact point David B. Bharucha, MD, PhD, FACC
    B.5.3 Address:
    B.5.3.1Street AddressHarborside Financial Center, Plaza V, Suite 1900
    B.5.3.2Town/ cityJersey City
    B.5.3.3Post codeNJ 07311
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1201427-8647
    B.5.5Fax number+1201427-8647
    B.5.6E-maildavid.bharucha@frx.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 nameApadenoson-DP
    D.3.2Product code apadenoson
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNapadenoson-DP
    D.3.9.1CAS number 250386-15-3
    D.3.9.3Other descriptive name4-{3-[6-Amino-9-((2R,3R,4S,5S)-5-ethylcarbamoyl-3,4-dihydroxy-tetrahydro-furan-2-yl)-9H-purin-2-yl]-prop-2-ynyl}-cyclohexanecarboxylic acid methyl ester; Cyclohexanecarboxylic acid, 4-[3-[6-amino-9-[N-ethyl-β-D- ribofuranuronamidosyl)-9H-purin-2-yl]-2-propynyl - methyl ester, ]- trans; Methyl trans-4[3[6-amino-9-(N-ethyl-β-D- ribofuranosyluronamide)-9H-purin-2-yl] prop -2-ynyl]cyclohexanecarboxylate
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 RoleComparator
    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 ADENOSCAN® 30 mg/10 ml, solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-aventis
    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 nameadenosine
    D.3.4Pharmaceutical form Solution for infusion
    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 INNAdenosine
    D.3.9.1CAS number 58-61-7
    D.3.9.4EV Substance CodeSUB00297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Coronary Artery Disease
    E.1.1.1Medical condition in easily understood language
    Heart 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 14.0
    E.1.2Level PT
    E.1.2Classification code 10011078
    E.1.2Term Coronary artery disease
    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
    To demonstrate non-inferiority between the level of agreement in diagnosis (i.e. patient classification of normal, mild/moderate or severe ischemic disease based on the number of reversible perfusion segments) between sequential adenosine SPECT-MPI versus sequential SPECT-MPI with adenosine and apadenoson.
    E.2.2Secondary objectives of the trial
    Secondary Gatekeeper Objectives
    To demonstrate a statistically significant reduction with apadenoson treatment compared with adenosine treatment in the following treatment emergent AEs:
    • Incidence of dyspnea
    • VAS Symptom-Intensity Measure of dyspnea
    • Incidence of flushing
    • VAS Symptom-Intensity Measure of flushing
    • Incidence of chest pain
    • VAS Symptom-Intensity Measure of chest pain
    • Incidence of headache
    • VAS Symptom-Intensity Measure of headache
    • Incidence of nausea
    • VAS Symptom-Intensity Measure of nausea
    • Incidence of dizziness
    • VAS Symptom-Intensity Measure of dizziness
    • Incidence of abdominal discomfort
    • VAS Symptom-Intensity Measure of abdominal discomfort

    Other Secondary Objectives (refer to protocol)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be considered for inclusion in this study:
    • Referred for a clinically indicated rest /pharmacologic stress SPECT-MPI study
    • Male or female subject, 18 years of age or older
    • Must be able to provide written informed consent to participate before beginning any trial related activities
    • Must be able to communicate effectively with trial personnel
    • Subjects must have either high pretest probability of CAD based on age and gender and chest pain symptomatology assessed using the ACC/AHA guidelines for relative risk
    OR
    Have previously demonstrated known coronary artery disease based on medical history of prior myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or diagnostic angiogram demonstrating 50% or greater stenosis in one or more vessel, as well as reporting chest pain indicative of angina or anginal equivalents within the month prior to Pre-Study Evaluation (based on ACC criteria, e.g. dyspnea or extreme fatigue).
    • Can safely abstain from caffeine or methylxanthine containing foods for 24 hours, from dipyridamole for 24 hours, and from theophylline and methylxanthine containing medications for at least 72 hours (or 4 half-lives, whichever is longer)
    • Cardiovascular medication routine must remain stable from the time of signed informed consent through the Period 2 SPECT-MPI
    • If female, be (a) at least one year post menopausal or surgically sterile or (b) nonpregnant (as determined by a negative urine β-hCG pregnancy test within 24 hours before each period imaging session), and (c) non-lactating. Women of childbearing potential (WOCBP) must have been practicing a medically approved method of birth control since their last menstrual period and be willing to utilize adequate contraception and not become pregnant during the full course of the study. Adequate contraception is defined as continuous use of 1 of the following:
    o Norplant® (inserted at least 3 months prior to administration)
    o Medroxyprogesterone acetate injection (given >14 days prior to signed informed consent)
    o Oral contraception (stable use for 2 or more cycles prior to the time of signed informed consent and throughout the study)
    o Double-barrier method (e.g., condom or diaphragm plus spermicide, sponge, foam or jelly)
    o Intrauterine device (IUD, inserted >4 weeks prior to the time of signed informed consent)
    o Monogamous partner with a bilateral vasectomy (procedure performed >3 months prior to the time of signed informed consent)
    o Bilateral tubal ligation
    o Abstinence
    E.4Principal exclusion criteria
    Subjects meeting any of the following exclusion criteria will not be included in the study:
    • Ingestion of a caffeinated or methylxanthine food substance (e.g. chocolate, cocoa) within 24 hours before receiving apadenoson or adenosine
    • Treatment with dipyridamole within 24 hours, or theophylline, aminophylline, or pentoxifylline within 72 hours (or 4 half-lives, whichever is longer) prior to receiving apadenoson or adenosine
    • Exposure to any investigational drug or device within 30 days prior to the time of signed informed consent
    • Acute MI, new onset of ischemia or PCI within 30 days prior to SPECT-MPI at either Period 1 or Period 2; or CABG within 90 days prior to SPECT-MPI at either Period 1 or Period 2
    • Any prior allergic response to aminophylline, adenosine, Tc99m Sestamibi, Thallium 201 or Tc99m Tetrofosmin or any of their components or other contraindication to pharmacologic stress testing with adenosine
    • Active severe asthma or severe chronic obstructive pulmonary disease (COPD) which, in the Investigator’s opinion, places the subject at risk for severe bronchoconstriction
    • History or evidence of clinically significant high grade AV block (including type 2 second or third degree block) or sinus node disease, such as sick sinus syndrome or symptomatic bradycardia, in the absence of a functioning permanently implanted pacemaker
    • Evidence of hemodynamically significant valvular disease or outflow tract obstruction
    • Uncontrolled severe hypertension or malignant ventricular arrhythmias
    • Current significant illness or disorder including significant laboratory abnormalities, ECG abnormalities, or other pathology that could potentiate any adverse pharmacological event associated with a vasodilating drug or any abnormality that, in the opinion of the Investigator, could put the subject at risk
    • Pretreatment hypotension (systolic BP < 90 mm Hg) or tachycardia (HR > 100 bpm)
    • Known history of cerebral vascular accident or suspected transient ischemic attack within 30 days prior to signed informed consent
    • Psychological or addictive disorder which may interfere with an ability to provide informed consent
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the level of agreement of diagnosis (i.e. patient classification of normal, mild/moderate or severe ischemic disease based on the number of reversible perfusion segments) between sequential adenosine SPECT-MPI versus the level of agreement in diagnosis between an adenosine and an apadenoson SPECT-MPI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Period 1 SPECT-MPI 7 +/-7 days following pre-study evaluation.
    Period 2 SPECT-MPI to be taken within 9 +/- 6 days after Period 1 SPECT-MPI.
    E.5.2Secondary end point(s)
    Secondary Gatekeeper Objective:
    To demonstrate a statistically significant reduction with apadenoson treatment compared with adenosine treatment in the incidence and intensity measure of dyspnea, flushing, chest-pain, headache, nausea, dizziness and, abdominal discomfort.

    Other Secondary Objectives:
    • Assessment of adverse events (AEs), change in laboratory findings, physical examinations, vital signs, ECGs and number of discontinuations due to AEs
    •Incidence of atrioventricular (AV) block
    •Subject-rated Treatment experience
    • Agreement of Median Summed Stress Scores (SSS)
    • Interpretation of Wall Motion
    • Agreement of Extent of Ischemia
    • Comparison of Sensitivity and Specificity
    • Image Quality, Myocardial Region, Diagnostic Certainty and Overall Findings
    • Detection of Perfusion Defects According to Coronary Artery Territory


    • Estimate PK parameters of Apadenoson and ATL146a
    E.5.2.1Timepoint(s) of evaluation of this end point
    Period 1 SPECT-MPI 7 +/-7 days following pre-study evaluation.
    Period 2 SPECT-MPI to be taken within 9 +/- 6 days after Period 1 SPECT-MPI.
    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 Yes
    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
    Tolerability
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    double-dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Argentina
    Belgium
    Brazil
    Netherlands
    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
    Last Visit, Last Subject
    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 months3
    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 months5
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 315
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 355
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 670
    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 as per standard of care after the end of the trial.
    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 Decision2011-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-18
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