Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2004-004976-35
    Sponsor's Protocol Code Number:CVT 5131
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-07-12
    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 number2004-004976-35
    A.3Full title of the trial
    A Phase III, Randomized, Double-Blind Study of Intravenous CVT 3146 vs. Adenoscan® in Patients Undergoing Stress Myocardial Perfusion Imaging
    A.3.2Name or abbreviated title of the trial where available
    CVT 5131
    A.4.1Sponsor's protocol code numberCVT 5131
    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 SponsorCV Therapeutics, 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 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.3.1Product nameRegadenoson
    D.3.2Product code CVT-3146
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INN2-[4-(methylamino)carbonyl]-1H-pyrazol-1-yl adenosine
    D.3.9.1CAS number 313348-27-5
    D.3.9.2Current sponsor codeCVT-3146
    D.3.9.3Other descriptive nameRegadenoson
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection*
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Myocardial Ischaemia (diagnosis of )
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10028601
    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 demonstrate that the strength of agreement between CVT - 3146 and adenosine images is not inferior to the strength of agreement between two sequential adenosine images. The primary measure of agreement will be based on the number of segments with reversible defects determined by an image assessment of three independent expert readers blinded to treatment assignment.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to:

    •Compare the safety and tolerability of CVT - 3146 to that of adenosine.
    •Compare agreement of image pairs (CVT - 3146 vs. adenosine and adenosine vs. adenosine) with regard to reader SSS, overall findings (normal, abnormal), and a paired (side-by-side) comparison of ischemic extent determined by the assessment of three independent expert readers blinded to treatment assignment.
    •Compare the strength of agreement of CVT- 3146 and adenosine images to the strength of agreement of sequential adenosine images within subgroups of patients determined by the estimated probability of having coronary artery disease based on the Diamond and Forrester classifications.
    •For the subgroup of patients for whom angiography results are obtained, compare adenosine and CVT - 3146 sensitivity and specificity.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Inclusion Criteria:
    •Males or females > or = 18 years of age
    •Referred for a clinically indicated pharmacological stress SPECT MPI
    •Adequate IV access in both arms
    •Willing to comply with the requirements of the protocol
    •Provided written Informed Consent to participate in the study approved by an appropriately constituted Institutional Review Board / Independent Ethics Committee (IRB/IEC)
    •Provided HIPAA authorization (US residents only)
    After the initial adenosine scan, patients must continue to meet all the inclusion and exclusion criteria.

    The following additional qualifying criteria must be met in order to be randomized to receive either CVT 3146 or adenosine for SPECT stress images.

    •Adenosine images must be of good quality and have been acquired at least 24 hours and no more than 30 days before the subsequent randomized scan
    •Initial adenosine scan infusion must be at least 5 ½ minutes at 140 mcg/kg/min ±10 mcg/kg/min.
    •Stable medication regimen (i.e., no changes in medications that would be likely to alter the rate pressure product) must be maintained during the interval between the initial and second study
    These medications include: beta blockers, calcium channel blockers, long-acting nitrates, ACE inhibitors, etc. These medications can be continued the day before each scan, but should preferentially be withheld the morning of the scans. If the withholding of these medications is contra-indicated, the medications may be continued on the day of the clinically indicated scan, provided that the same dosing and frequency regimen is then applied for the randomized scan, and also provided that the patient is administered both stress agents at approximately the same time of day (within one hour). Sublingual nitroglycerin is not allowed within 2 hours of either the initial or randomized study.
    •Stable clinical condition with no meaningful change in signs or symptoms
    •Once randomization has been closed to patients with 0-1 reversible segments, the initial scan must have at least 2 segments showing reversible defects

    E.4Principal exclusion criteria
    Exclusion Criteria
    •History of coronary revascularization (PTCA, CABG or TMR (transmyocardial revascularization)) within 6 months prior to enrollment
    •Prior cardiac transplantation
    •Documented history of acute myocardial infarction or unstable angina within 3 months prior to enrollment
    •Known history of hypertrophic cardiomyopathy with resting gradient
    •History of greater than first degree AV Block, except for patients with a functioning artificial pacemaker
    •History of acute myocarditis or pericarditis
    •History of sick sinus syndrome, except for patients with a functioning artificial pacemaker
    •History of severe aortic stenosis
    •History of serious uncontrolled ventricular arrhythmia (any life-threatening ventricular arrhythmia, e.g., ventricular arrhythmia with hemodynamic compromise within the last 3 weeks and unresponsive to anti-arrhythmic medication therapy, or without automatic implantable cardiac defibrillator (AICD) backup, etc.)
    •History of known or suspected bronchoconstrictive and bronchospastic lung disease (e.g., asthma, wheezing noted on physical exam or history of wheezing requiring a bronchodilator or corticosteroids)
    •Known susceptibility to symptomatic hypotensive reactions (e.g., hypovolemia causing symptomatic hypotension)
    •Known condition of symptomatic bradycardia
    •Uncontrolled hypertension (> 200/120 mmHg) within 30 days
    •Currently on theophylline / aminophylline
    •Unable to discontinue dipyridamole for a period of 30 hours prior to each scan
    •Known allergy to theophylline / aminophylline
    •Sublingual nitroglycerin within 2 hours of receiving pharmacological stress agent
    •Known hypersensitivity to adenosine
    •Pregnant or breast feeding, or (if pre-menopausal), not practicing acceptable method of birth control
    •Consumption of methylxanthine-containing products such as caffeinated coffee, tea, and soft drinks (e.g., Coke, Pepsi, Mountain Dew), theophylline, cocoa and chocolate within 12 hours prior to receiving pharmacological stress agent
    •Any condition which may, in the Investigator's opinion, preclude the safe use of adenosine in the patient
    •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
    •Participation in another investigational drug study within 1 month prior to enrollment into this study
    •Participation in a previous trial studying CVT 3146

    After the initial adenosine scan, patients must continue to meet all the inclusion and exclusion criteria. Any patient who has experienced an event or condition described in the exclusion criteria (e.g., uncontrolled ventricular arrhythmia, myocardial infarction, or persistent or symptomatic hypotension) should be discontinued.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the agreement between CVT - 3146 and adenosine SPECT images for the detection of inducible abnormalities of myocardial perfusion (i.e myocardial ischemia).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability of Regadenoson vs. adenosine
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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.8.5The 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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    After the collection of the angiography data for the last patient enrolled
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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 2005-07-12. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state80
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1070
    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)
    Subjects will revert to standard care after participation in the trial has ended.
    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 Decision2005-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-08-29
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 02:32:31 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA