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    Summary
    EudraCT Number:2013-001225-11
    Sponsor's Protocol Code Number:T58/2013
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-05-13
    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 number2013-001225-11
    A.3Full title of the trial
    Quantitative myocardial perfusion response to adenosine and regadenoson in patients with suspected coronary artery disease
    Adenosiinin ja regadenosonin vertailu sydänlihaksen verenvirtauksen PET tutkimuksessa sepelvaltimotautia sairastavilla potilailla
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two medicines in heartr perfusion stress studies.
    Adenosiinin ja regadenosonin vertailu sydänlihaksen verenvirtauksen PET tutkimuksessa sepelvaltimotautia sairastavilla potilailla
    A.3.2Name or abbreviated title of the trial where available
    RegWater
    RegWater
    A.4.1Sponsor's protocol code numberT58/2013
    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 SponsorTurku University Hospital
    B.1.3.4CountryFinland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTurku University Hospital
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportRapidScan Pharma/Cardirad Finland
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTurku University Hospital
    B.5.2Functional name of contact pointTurku University Hospital
    B.5.3 Address:
    B.5.3.1Street AddressHämeentie 11
    B.5.3.2Town/ cityTurku
    B.5.3.4CountryFinland
    B.5.6E-mailesanra@utu.fi
    D. IMP Identification
    D.IMP: 1
    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 Adenocor
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis oy
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameAdenocor
    D.3.4Pharmaceutical form 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.3.9.3Other descriptive nameADENOSINE
    D.3.9.4EV Substance CodeSUB00297MIG
    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 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 Rapiscan
    D.2.1.1.2Name of the Marketing Authorisation holderRapidscan Pharma Solutions EU Ltd
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameRapidcan
    D.3.4Pharmaceutical form 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.3.9.1CAS number 313348-27-5
    D.3.9.3Other descriptive nameREGADENOSON
    D.3.9.4EV Substance CodeSUB30494
    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
    Coronary artery desease
    Sepelvaltimotauti
    E.1.1.1Medical condition in easily understood language
    Coronary artery desease
    Sepelvaltimotauti
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    Aim of the present study is to directly compare the quantitative flow responses or Regadenoson against adenosine using cardiac O-15-water PET imaging in patients with suspected or known CAD. The study will provide information on whether:
    1) Regadenoson induces similar quantitative increase in myocardial perfusion than adenosine
    2) The ischemic and non-ischemic regions have similar response to Regadenoson than to adenosine.
    Tämän tutkimuksen tavoitteena on verrata adenosiinin ja regadenosonin aiheuttamia määrällisiä muutoksia sydänlihaksen verenvirtauksessa potilailla, joilla tiedetään tai epäillään olevan sepelvaltimotauti. Tämän tutkimuksen on myös tarkoitus selventää, lisääkö Regadenoson sydänlihaksen verenvirtausta saman verran kuin adenosiini. Lisäksi selvitetään reagoivatko terveet sydänlihasalueet samalla tavalla sekä regadenosoniin että adenosiiniin.
    E.2.2Secondary objectives of the trial
    We will find out weather similar absolute perfusion cut-off values can be used for diagnostic purposes.
    Selvitämme myös, voidaanko samoja diagnostisia raja-arvoja käyttää molemmilla lääkeaineilla.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    One of the following:
    Age 18-80
    Suspected CAD and referred for cardiac PET perfusion imaging based on clinical indications
    Known CAD and referred for cardiac PET perfusion imaging based on clinical indications
    Patients have been or are referred for coronary angiography, either noninvasive or invasive
    Informed consent from the patient
    18-80 vuoden ikä
    Epäily tai tiedossa oleva sepelvcaltimotauti
    Lähete sepelvaltimoiden invasiiviseen tai non-invasiiviseen kuvantamiseen
    Kirjallinen suostumus
    E.4Principal exclusion criteria
    Continuing, uncontrolled unstable angina symptoms or urgent CABG after invasive coronary angiography
    ST-elevation myocardial infarction (STEMI)
    EF < 40% or diagnosis of cardiomyopathy
    Prior coronary artery bypass grafting (CABG)
    Haemophilia, Von Willebrand's disease or other coagulation disorder
    Severe pulmonary disease
    Symptomatic asthma
    Severe valvular disease
    Uncontrolled hypertension (>180/110 mmHg)
    Moderate to severe renal failure
    Women with childbearing potential
    Age < 18 or > 80 years
    Unstable asthma
    II or III degree AV block or sick sinus syndrome without pacemaker
    Severe hypotension (systolic bloodpressure < 90 mmHg),
    Allergy to x-ray contrast agents (patients have also angiography)
    Tutkimuksesta on poissuljettu henkilöt, joilla on epästabiilin sepelvaltimotaudin oireet, ST-nousu infarkti, sydämen vajaatoiminta, aiemmin todettu kardiomyopatia, aiempi ohitusleikkaus, veren hyytymiseen vaikuttava sairaus, vaikea keuhkosairaus, oireinen tai epästabiili astma, vaikea läppävika, kontrolloimaton hypertensio (> 180/110mmHg), vaikea tai keskivaikea munuaisten vajaatoiminta tai jokin muu vasta-aihe PET/TT kuvaukselle. Tutkimushenkilöiksi ei oteta alle 18 ja yli 80-vuotiaita, eikä hedelmällisessä iässä olevia naisia.
    E.5 End points
    E.5.1Primary end point(s)
    The reaction of heart´s perfusion to the medications.
    Sydänlihaksen perfuusiomuutokset lääkeaineiden vaikutuksesta.
    E.5.1.1Timepoint(s) of evaluation of this end point
    20min
    20min
    E.5.2Secondary end point(s)
    The cut off values of Regadenoson.
    Regadenosonin raja-arvot.
    E.5.2.1Timepoint(s) of evaluation of this end point
    20min
    20min
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    Rasituslääkkeet annetaan avoimesti, kuvat analysoidaan sokkoutetusti.
    The stress medication is given openly, the images are analysed blinded
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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 Decision2013-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-21
    P. End of Trial
    P.End of Trial StatusOngoing
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