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    Summary
    EudraCT Number:2010-021526-36
    Sponsor's Protocol Code Number:LMU_Rad_MR_GadoMRA01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-12-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-021526-36
    A.3Full title of the trial
    Dynamic and high-resolution MR angiography of the supraaortic vessels at 3 Tesla: Performance of Gadobutrol (Gadovist) in comparison to Gedobenate Dimeglumine (Multihance) and Gadoterate Meglumine (Dotarem) at equimolar dose (0.1 mmol/kg BW) in volunteers and patients with carotid artery stenosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the performance of three contrast agents (Gadovist, Dotarem and Multihance) in magnetic resonance imaging (MRI) in volunteers and patients with narrowing or constriction of the inner surface of the carotid artery
    A.3.2Name or abbreviated title of the trial where available
    Gadovist in MR angiography
    A.4.1Sponsor's protocol code numberLMU_Rad_MR_GadoMRA01
    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 SponsorKlinikum der Universität München
    B.1.3.4CountryGermany
    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 supportBayer Schering Pharma AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinikum der Universität München
    B.5.2Functional name of contact pointInstitut für Klinische Radiologie
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistr. 15
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number00498970952750
    B.5.5Fax number00498970958822
    B.5.6E-mailwebmaster.radiologie@med.uni-muenchen.de
    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
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 INNGadobutrol
    D.3.9.1CAS number 138071-82-6
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/ml millimole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Yes
    D.3.11.13.1Other medicinal product typeparamagnetic contrast agent for MRI
    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 Dotarem
    D.2.1.1.2Name of the Marketing Authorisation holderGuerbet
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 INNGadoteric Acid
    D.3.9.1CAS number 72573-82-1
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/ml millimole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 Yes
    D.3.11.13.1Other medicinal product typeparamagnetic contrast agent for MRI
    D.IMP: 3
    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 Multihance
    D.2.1.1.2Name of the Marketing Authorisation holderBracco Imaging Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 INNGADOBENIC ACID
    D.3.9.1CAS number 113662230
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/ml millimole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 Yes
    D.3.11.13.1Other medicinal product typeparamagnetic contrast agent for MRI
    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
    Supraaortic vessel disease; suspicion or proven carotid artery stenosis / stenoses
    E.1.1.1Medical condition in easily understood language
    narrowing or constriction of the inner surface of the large artery on both sides of the neck, usually caused by thickening of the artery wall due to a build-up of fatty materials
    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 13.1
    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
    Primary objective are:
    To compare the performance of 1 molar gadobutrol in dynamic and static high resolution supraaortic MR angiography with two different 0.5 molar Gd-chelates exhibiting weak (gadobenate dimeglumine) or no (gadoterate meglumine) protein binding at 3 Tesla using equimolar doses.

    Primary objective of the volunteer study is to provide estimates of the overall assessment of contrast enhancement of the three contrast agents as the basis for the sample size calculation of the subsequent patient study.

    Primary objective of the patient study is to show that the contrast enhancement of gadobutrol is not inferior to gadobenate dimeglumine (MultiHance®) and superior to gadoterate meglumine (Dotarem®).
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    • to compare vessel signal-to-noise (SNR) and contrast-to-noise (CNR) in high resolution MR angiography at the carotid bifurcation and at the intracranial internal carotid artery at the level of carotid T
    • to compare vessel signal-to-noise (SNR) and contrast-to-noise (CNR) in dynamic MR angiography at the carotid bifurcation and at the intracranial internal carotid artery at the level of carotid T
    • to document safety data for the three compounds
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Volunteer part:
    1. age: at least 18 years
    2. no history of cardiovascular disease
    3. willing to undergo all study procedures
    4. has voluntarily signed and dated the informed consent form
    Women of childbearing potential:
    5. a negative pregnancy test (urine test) on the day of contrast agent administration
    6. use of a highly effective method of birth control during the duration of the study (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner)

    Patient part:
    1. age: at least 18 years
    2. suspicion or proven carotid artery stenosis / stenoses
    3. willing to undergo all study procedures
    4. has voluntarily signed and dated the informed consent form
    Women of childbearing potential:
    5. a negative pregnancy test (urine test) on the day of contrast agent administration
    6. use of a highly effective method of birth control during the duration of the study (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner)
    E.4Principal exclusion criteria
    Volunteer part:
    1. if female:, pregnant or nursing
    2. history of renal disease, subjects in the perioperative liver transplantation period and / or with acute or chronic severe renal impairment
    3. GFR <60ml/m²/1.73m² (MDRD) as determined from a serum creatinine value not older than 4 weeks before MR contrast agent injection
    4. contraindications against MR imaging (e.g. subjects with implanted ferromagnetic objects (pacemaker, vascular clip))
    5. contraindications against any of the three MR contrast agents (e.g. aggravation of anaphylactic-like reactions in patients on beta-blockers, and particularly in the presence of bronchial asthma, low seizure threshold in patients with CNS disorders, patients with uncorrected hypokalemia, severe cardiovascular disease)
    6. severe claustrophobia
    7. history of anaphylactoid or anaphylactic reaction to any allergen (e.g. hay fever, urticaria, asthma, history of sensitivity to benzyl alcohol, etc.) including drugs and contrast agents
    8. having received any investigational drug within 7 days prior to entering this study
    9. planned to receive any investigational drug during the study period
    10. close affiliation with the investigational site (e.g., close relative of an investigator)
    11. participating in another clinical trial
    12. having been previously enrolled in this clinical trial
    13. any medical condition that potentially reduces cardiac output


    Patient part:
    1. if female:, pregnant or nursing
    2. history of renal disease, subjects in the perioperative liver transplantation period and / or with acute or chronic severe renal impairment
    3. GFR <30ml/m²/1.73m² (MDRD) as determined from a serum creatinine value not older than 4 weeks before MR contrast agent injection
    4. contraindications against MR imaging (e.g. subjects with implanted ferromagnetic objects (pacemaker, vascular clip))
    5. contraindications against any of the three MR contrast agents (e.g. aggravation of anaphylactic-like reactions in patients on beta-blockers, and particularly in the presence of bronchial asthma, low seizure threshold in patients with CNS disorders, patients with uncorrected hypokalemia, severe cardiovascular disease)
    6. severe claustrophobia
    7. history of anaphylactoid or anaphylactic reaction to any allergen (e.g. hay fever, urticaria, asthma, history of sensitivity to benzyl alcohol, etc.) including drugs and contrast agents
    8. having received any investigational drug within 7 days prior to entering this study
    9. planned to receive any investigational drug during the study period
    10. close affiliation with the investigational site (e.g., close relative of an investigator)
    11. participating in another clinical trial
    12. having been previously enrolled in this clinical trial
    13. any medical condition that potentially reduces cardiac output
    14. prior carotid artery stenting on investigated body side
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy analysis is based on the overall assessment of contrast enhancement comparing two pairs of contrast agents (volunteer study) and each two contrast agents (2 groups, patient study). The volunteer study is set up as exploratory pilot study and will provide estimates for the overall assessment of contrast enhancement of the three contrast agents as basis for the sample size of the patient study.
    Overall assessment of contrast enhancement on a 3-point scale (better, equal, worse) in a matched pairs assessment from all MR imaging data. For the primary analysis, the assessments of the blinded readers will be combined after the blinded reading.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After acquisition of all MR images (volunteers and patients) and assessment by blinded readers.
    E.5.2Secondary end point(s)
    1. Signal-to-Noise-Ratio and Contrast-to-Noise-Ratio at the following levels: carotid bifurcation, intracranial internal carotid artery at the level of the carotid T
    2. Contrast enhancement rate in dynamic MR angiography at the following levels: carotid bifurcation, intracranial internal carotid artery at the level of the carotid T
    3. Degree of stenosis (pre contrast agent; patients only)
    4. AEs as elicited upon indirect questioning.
    The secondary efficacy variables and safety variables will be analyzed descriptively. Two-sided 95% confidence intervals will be given where appropriate.


    E.5.2.1Timepoint(s) of evaluation of this end point
    After acquisition of all MR images (volunteers and patients) and assessment by blinded readers.
    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 No
    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 Yes
    E.7.1.3.1Other trial type description
    diagnostic
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    intra-individual comparison
    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
    comparison between 3 contrast agents
    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 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 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
    last patient last visit
    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 months0
    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 months0
    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.1.1.2Preterm 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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 2010-12-03. 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 20
    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)
    Post-study therapy will follow routine clinical 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 Decision2011-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-29
    P. End of Trial
    P.End of Trial StatusOngoing
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