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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:2010-023001-36
    Sponsor's Protocol Code Number:BAY86-4875/14607
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-03-30
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2010-023001-36
    A.3Full title of the trial
    Multicenter, open-label study to evaluate the safety and efficacy (by
    blinded reading) of contrast-enhanced magnetic resonance angiography
    (MRA) after a single intravenous injection of 0.1 mmol/kg gadobutrol in
    subjects with known or suspected vascular disease of the supra-aortic
    vessels
    Multicentrické, otevřené klinické hodnocení bezpečnosti a účinnosti (zaslepeným vyhodnocením) angiografie magnetickou rezonancí (MRA) s kontrastní látkou gadobutrolem po jedné intravenózní injekci gadobutrolu (0,1 mmol/kg) pacientům se známým nebo suspektním onemocněním supraaortálních cév.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Contrast-Enhanced MRI of the supra-aortic vessels
    A.3.2Name or abbreviated title of the trial where available
    Gadobutrol-enhanced MRA study of the supra-aortic vessels (GEMSAV)
    A.4.1Sponsor's protocol code numberBAY86-4875/14607
    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 SponsorBayer Health Care AG
    B.1.3.4CountryGermany
    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 supportBayer Health Care AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation Bayer Health Care AG
    B.5.2Functional name of contact pointCTP Team / Ref: "EU CTR" / S102 - R
    B.5.3 Address:
    B.5.3.1Street AddressMüllerstr. 170-178
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post codeD-13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 Yes
    D.2.1.1.1Trade name Gadovist® 1.0 mmol/ml, solution for injection
    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 nameGadovist® 1.0 mmol/ml, solution for injection
    D.3.2Product code BAY 86-4875
    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 INNgadobutrol
    D.3.9.1CAS number 138071-82-6
    D.3.9.2Current sponsor codeBAY 86-4875
    D.3.9.3Other descriptive nameGADOBUTROL
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/kg millimole(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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 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
    Subjects with known or suspected vascular disease of the supra-aortic vessels
    E.1.1.1Medical condition in easily understood language
    Known or suspected disease of the supra-aortic vessels
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10007687
    E.1.2Term Carotid artery stenosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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 efficacy evaluation will be based on three primary efficacy variables:
    • Assessability
    • Sensitivity
    • Specificity
    which will be calculated for both gadobutrol-enhanced MRA and non-contrast ToF MRA.
    These will be used to evaluate five co-primary endpoints:
    - Proportion of assessable vascular segments
    - Sensitivity for detection of clinically significant disease [70 to 99%
    stenosis] on a segmental basis
    - Specificity for exclusion of clinically significant disease [70 to 99% stenosis]
    on a segmental basis
    - The two minimum gadobutrol performance criteria:
    Sensitivity > 50%
    Specificity > 50%
    E.2.2Secondary objectives of the trial
    A further objective of this study is to confirm the safety profile of gadobutrol for this indication.

    The secondary efficacy assessments will include the following:
    • Minimum diameter of the segment
    • Location and length of stenotic segments with ≥ 70% stenosis
    • Secondary radiologic indicators for diagnosis of clinically significant disease
    • Artifacts by type (segmental)
    • Diagnostic confidence (segmental)
    • Additional imaging studies recommended (example: CTA, CE MRA,
    Ultrasound, Nuclear Medicine)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female subjects, aged 18 years and older
    - Any of the following:
    - Known or suspected supra-aortic arterial disease based on:
    - Prior stroke
    - Transient ischemic attack (TIA)
    - Amaurosis Fugax (transient monocular blindness)
    - Referred for evaluation of any supra-aortic vessel (for clinically significant stenosis)
    - Follow-up for a stent in a supra-aortic vessel
    - Prior imaging study (CTA or ultrasound) showing ≥ 50% stenosis of a supra-aortic vessel segment (within 60 days before consent). The proportion of subjects with positive disease (determined by the investigator, based on CTA or ultrasound) will be monitored during the study, and enrolment may be further restricted to require ≥ 70% stenosis to ensure that overall there are an adequate number of subjects with clinically significant disease for the evaluation of study endpoints
    - Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography [CE MRA] examination with gadobutrol
    - Willingness and ability to follow directions and complete all study procedures specified in the protocol
    - Females of childbearing potential only: Negative pregnancy test on the day of the MRA before the administration of study drug
    E.4Principal exclusion criteria
    - Pregnant or nursing (including pumping for storage and feeding)
    - Received any other investigational product or participation in any other clinical trial within 30 days before enrollment into this study
    - Previous enrollment into this study or into any other Bayer sponsored study using gadobutrol
    - Contraindication to the MRA examinations (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI)
    - Contraindication to the use of Gd-containing contrast agents (including subjects with suspicion for or known to have Nephrogenic Systemic Fibrosis [NSF])
    - History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
    - Received any contrast agent within 72 hours before the study MRA, or scheduled receipt of any contrast agent within 24 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study.)
    - Estimated glomerular filtration rate (eGFR) value < 30 ml/min/1.73 m2 derived from a serum creatinine result within 2 weeks before the gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from participation. Use the value obtained prior to and closest to the time of the MRA, if there are multiple creatinine values. (Do not use the core lab value if not available prior to the MRA.)
    - Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period
    - Severe cardiovascular disease (e.g. acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome
    - Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery)
    - Scheduled or potentially expected for the period between the CTA and gadobutrol MRA:
    - Any procedure that may alter the MRA or CTA interpretation, or
    - Any interventional or surgical procedure involving the supra-aortic vessels
    E.5 End points
    E.5.1Primary end point(s)
    The following co-primary efficacy endpoints are based on the proportion of assessable vascular segments, and the sensitivity and specificity of clinically significant disease:
    - Superiority in the proportion of assessable segments with gadobutrol enhanced MRA compared to non-contrast MRA
    - Non-inferior detection of clinically significant disease based on sensitivity [70 to 99% stenosis] on a segmental basis
    - Non-inferior exclusion of clinically significant disease based on specificity [70 to 99% stenosis] on a segmental basis
    - The two minimum gadobutrol performance criteria (both sensitivity and specificity should exceed 50%)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to two weeks
    E.5.2Secondary end point(s)
    The following secondary efficacy variables will be summarized:
    - Minimum diameter of the segment
    - Location and length of stenotic segments with ≥ 70% stenosis
    - Secondary radiologic indicators for diagnosis of clinically significant disease
    - Artifacts by type (segmental)
    - Diagnostic confidence (segmental)
    - Additional imaging studies recommended (example: CTA, CE MRA, Ultrasound, Nuclear Medicine)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to two weeks
    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 No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Australia
    Austria
    China
    Czech Republic
    France
    Germany
    Italy
    Korea, Republic of
    Poland
    Sweden
    Switzerland
    Turkey
    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
    For each participating EU country, the end of the study (according to the EU Clinical Trial Directive) will be reached when the last visit of the last subject for all centers in the respective country has occurred.
    As for this study, the primary outcome will be collected after last patient (or subject) last visit (LPLV), the end of the study as a whole will be the date when the clean data base is available.
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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.1.3Elderly (>=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 Yes
    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 2011-03-30. Yes
    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
    If the subject is not capable of providing a signature, a verbal statement of consent can also be given in the presence of an impartial witness.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 265
    F.4.2.2In the whole clinical trial 398
    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)
    Not applicable for this diagnostic study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Not Applicable
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
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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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