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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2008-003839-20
    Sponsor's Protocol Code Number:CVT5127
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-07-16
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-003839-20
    A.3Full title of the trial
    A Open-Label, Parallel-Group, Exploratory Study to Evaluate the Efficacy and Safety of 400 µg Regadenoson Bolus for Pharmacological Stress Echocardiography
    A.4.1Sponsor's protocol code numberCVT5127
    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 SponsorGilead Sciences, 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 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 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 nameRegadenoson
    D.3.2Product code CVT-3146
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNRegadenoson
    D.3.9.1CAS number 875148-45-1
    D.3.9.2Current sponsor codeCVT-3146
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.8
    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.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 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.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNSulphur hexafluoride
    D.3.9.1CAS number 2551-62-4
    D.3.10 Strength
    D.3.10.1Concentration unit µl/ml microlitre(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number8
    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
    Suspected coronary artery disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10011078
    E.1.2Term Coronary artery disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of a 400 µg regadenoson bolus for pharmacological stress echocardiography by comparing the stress echocardiographic images obtained after dobutamine with those obtained after regadenoson alone, regadenoson with low-level exercise (25W), regadenoson with echocontrast agent, and by comparing PSE images obtained after dipyridamole with those obtained after regadenoson.
    E.2.2Secondary objectives of the trial
    To evaulate the safety of regadenoson as a pharmacologic stress agent for echocardiography.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females ≥ 18 years of age.
    2. For Groups A, B, B-1 and C: Had a clinically indicated dobutamine stress echocardiogram (without contraindications for receiving dobutamine) with the following results:
    a) Adequate image quality with 4 or more segments evaluable in each view (apical 4-chamber, apical 3-chamber, apical 2-chamber and parasternal short-axis view at the papillary muscle level)
    b) Definitively normal images (i.e. uniformly normal wall excursion and wall thickening) at rest and definitive reversible wall motion abnormalities during stress (Hypokinesia - reduced inward systolic wall motion; Akinesia - absence of both inward motion and of thickening; Dyskinesia - systolic thinning and outward systolic wall motion).
    3. For Group D: Had a clinically indicated pyridamole PSE (without contraindications for receiving pyridamole) either before or during screening with the following results:
    a)Adequate image quality with 4 or more segments evaluable in each view (apical 4-chamber, apical 3-chamber, and apical 2-chamber view)
    b) At rest, definitively normal perfusion and generally normal wall motion (defined as ≤ 2 segments with wall motion abnormalities) and, with stress, definitively abnormal perfusion (delayed or absent replenishment of contrast after a high MI destruction pulse sequence) with or without abnormal wall motion.
    Note: Patients who have not had a dipyridamole PSE, but who are referred for clinically indicated stress echocardiography and for whom pyridamole PSE is clinically appropriate may undergo the qualifying dipyridamole PSE at screening. The results of that qualifying dipyridamole PSE must meet the above criteria before the patient may be enrolled in the protocol.
    4. During the interval between the clinically indicated dobutamine (Groups A, B, B-1 and C) or dipyridamole (Group D) stress echocardiogram study and the regadenoson stress echocardiogram study the following conditions are required:
    a) Patients’ medical conditions must be stable (no change in symptoms)
    b) No change in cardioactive medications including but not limited to beta blockers, calcium channel blockers, long acting nitrates, ACE (angiotensin converting enzyme) inhibitors, ARBs (angiotensin II receptor blocking agents) and ranolazine
    c) No coronary intervention (PTCA or stenting).
    5. By 8PM the night before the regadenoson dosing, patients who have not taken beta blockers before dobutamine/dipyridamole dosing in accordance with the site’s routine practice and are willing to do the same on the day of the regadenoson stress echocardiogram are eligible. Preferably but not mandatory, other cardioactive medications that may impact an ischemic reaction to stress (including but not limited to calcium channel blockers, long acting nitrates, ACE inhibitors, ARBs, ranolazine, etc.) should not have been taken before dobutamine/dipyridamole dosing, and the same medications should be withheld before regadenoson dosing.
    6. For patients in Groups B, B-1 only: able to exercise at 25W for 5 minutes on an ergometer.
    7. Adequate intravenous access in both arms.
    8. Willing and able to comply with the requirements of the protocol and directions from clinic staff.
    9. Provided written Informed Consent (approved by an appropriately constituted IRB/IEC) to participate in the study.
    10. For female patients only: non-pregnant, non-lactating females must meet one of the following requirements:
    a) Post-menopausal (two years after the last menstrual period), or
    b) Surgically sterilized, or
    c) Women of childbearing potential must use an adequate contraceptive method (either double barrier or hormonal) for one month prior to signing consent, through one month after last dose of study drug. Patients must also have a negative pregnancy test upon consent and within 24 hours of regadenoson dosing.
    E.4Principal exclusion criteria
    1. History of coronary artery bypass graft (CABG), or transmyocardial revascularization (TMR).
    2. History of cardiac transplantation.
    3. Acute or documented history of ST-segment elevation myocardial infarction (STEMI) or Non-ST-segment elevation myocardial infarction acute coronary syndrome (NSTEMI-ACS) within 3 months before enrollment.
    4. History of greater than first degree AV block, sinoatrial block or sick sinus syndrome, atrial fibrillation, or serious uncontrolled ventricular arrhythmia (i.e., any life-threatening ventricular arrhythmia, such as ventricular arrhythmia with hemodynamic compromise).
    5. Artificial pacemaker (functional) or implantable cardiac defibrillator [ICD] backup.
    6. History of acute myocarditis or pericarditis, hypertrophic cardiomyopathy with resting gradient, severe aortic stenosis or other compromising structural heart disease that would, in the investigator’s judgment, compromise the safety of the patients during stress testing.
    7. Concurrent or history of either symptomatic bradycardia or a resting heart rate of > 100 bpm.
    8. Uncontrolled hypertension (> 200/120 mm Hg) within 30 days of study entry and patients who have shown an exaggerated pressor response to dobutamine.
    9. Hypotension (cuff systolic blood pressure < 90 mm Hg supine) at the time of screening.
    10. With respect to the qualifying echocardiongram:
    a) Groups A, B, B-1 and C: an exaggerated pressor response to dobutamine stress (hypotension or hypertension), clinically significant ventricular ectopy, or other major cardiovascular side effects that may jeopardize the safety of the patient
    b) Group D: hypersensitivity to dipyridamole, abnormalities of cardiac impulse formation or conduction, sever coronary artery disease, unstable angina, or other major side effects that may jeopardize the safety of the patient.
    11. In patients for Groups B-1, C and D, any contraindications to receiving the echocardiogram contrast agent SonoVue including but not limited to: known hypersensitivity to sulphur, hexafluoride, or to any of the components of SonoVue; patients with right-to-left shunts, severe pulmonary hypertension, uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome; recent acute coronary syndrome or clinically unstable ischemic cardiac disease, including evolving or ongoing myocardial infarction, typical angina at rest with the last 7 days, significant worsening of cardiac symptoms within the last 7 days, recent coronary intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings); acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders; chest pain or ECG modification within the 2 days before dosing.
    12. Known autonomic neuropathy with inadequate reaction to sympathetic stimulation (e.g. known inadequate heart rate increase under stress).
    13. Current unstable or uncontrolled asthma or other reactive airways disease, or wheezing noted on physical exam.
    14. Current treatment with theophylline/aminophylline preparations.
    15. Known hypersensitivity to theophylline, aminophylline, adenosine or any of its constituents.
    16. For both the qualifying echocardiogram as well as the regadenoson echocardiogram, unable to discontinue or refrain from:
    a) Dipyridamole for a period of 30 hours before each echocardiogram with the exception of the use of dipyrimadole as the stress agent for the qualifying echocardiogram for patients in Group D
    b) Sublingual nitroglycerin within 2 hours before and after receiving the pharmacologic stress agent.
    17. For the regadenoson echocardiogram only, unable to discontinue or refrain from methylxanthine-containing products such as caffeinated coffee, tea, and soft drinks (e.g., Coke, Pepsi, Mountain Dew), theophylline/aminophylline, cocoa and chocolate within 18 hours before receiving regadenoson.
    18. Pregnant or breast feeding, or (if pre-menopausal), not practicing acceptable method of birth control (see inclusion criterion #10).
    19. History of any other conditions which in the judgment of the investigator, are likely to hinder or confuse study conduct or to pose a safety concern to the patient due to the study procedures or regadenoson.
    20. Has participated in another investigational study within 1 month before enrollment into this study.
    21. Has participated in a previous trial studying regadenoson.
    E.5 End points
    E.5.1Primary end point(s)
    The study will continue until evaluable regadenoson and dobutamine/dipyridamole echocardiograms have been obtained for 10 patients in Groups A and B combined, and 10 patients each in Groups B-1, C and D.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Low-level exercise (25W)
    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.8.5The 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 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
    The study will continue until evaulable regadenoson and dobutamine/dipyridamole echocardiograms have been obtained for 10 patients in Groups A and B combined, and 10 patients each in Groups B-1, C and D.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    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 state56
    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)
    Local standard of care
    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 Decision2008-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-06-04
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