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    The EU Clinical Trials Register currently displays   37504   clinical trials with a EudraCT protocol, of which   6153   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-004325-25
    Sponsor's Protocol Code Number:MS325-19
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-09-20
    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 number2005-004325-25
    A.3Full title of the trial
    Comprehensive whole-body 3T MRA of Patients with Low or Moderate Clinical Probability for Pulmonary Embolism using an Intravascular MR Contrast Agent Vasovist®
    A.4.1Sponsor's protocol code numberMS325-19
    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 SponsorAdministration management, Ludwig-Maximilians-University of Munich
    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 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 Yes
    D.2.1.1.1Trade name Vasovist®
    D.2.1.1.2Name of the Marketing Authorisation holderSchering AG, Germany
    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 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 INNGadofosveset
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/kg millimole(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number0,03
    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 Information not present in EudraCT
    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
    Patients with low or moderate clinical probability for pulmonary embolism and positive or negative CTA for pulmonary embolism after CT and sonographic examination for deep venous thrombosis.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the feasibility and accuracy of comprehensive whole-body 3T MRA of patients with low or moderate clinical probability for pulmonary embolism using an intravascular MR contrast agent (Vasovist®) for detection of pulmonary embolism and underlying deep venous thrombosis in a single examination.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with low or moderate clinical probability for pulmonary embolism (Wells score, see appendix 1) and positive or negative CTA for pulmonary embolism.

    Patients who are willing to undergo MRA with Vasovist® -after getting a detailed information about the treatment by an (co)investigator- and will give their signed informed consent form.
    The distribution of gender is irrelevant. The patient group reflects the clinic's average.
    E.4Principal exclusion criteria
    Less than 18 years of age.
    Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test the same days as administration of Vasovist®. The manufacturer’s instructions for performing the urinary pregnancy test are to be followed.
    People with proven central pulmonary embolism (main left or right pulmonary artery)
    Known underlying pulmonary disease: e.g. lung cancer, chronic obstructive pulmonary disease
    Having an underlying disease or concomitant medication (or are scheduled for any therapy) which may interfere with efficacy or safety evaluations as planned in this study
    Having any physical or mental status that interferes with the informed consent procedure incl. self-signed consent.
    Having a history of alcohol or drug abuse or dependency.
    Having received any investigational drug within 30 days prior to entering this study or who are planned to receive any other investigational drug during the 24 (+ 4) hours safety follow-up period.
    Not being able to remain lying down for at least 45 – 60 min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain).
    Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents.
    Presenting sickle cell disease or other hemolytic anemia.
    Being clinically unstable
    Being scheduled for, or likely to require, any surgical intervention within 24 hours before or within the follow-up period.
    Having any contraindication to MRI examination or specifically for MRA (e.g. pacemaker, recent wound clips, and severe claustrophobia).
    High clinical probability for PE
    Patient who have received Gadolinum within 24 hours prior to Vasovist® injection.
    Patients with impaired renal function as indicated by CreatininClearance below 30ml/min (MDRD/Cockroft-Gault) (laboratory diagnostic data required)
    Patients with impaired liver function (laboratory diagnostic data required)

    E.5 End points
    E.5.1Primary end point(s)
    Feasibility: number technically successful MRI exams. A successful exam is defined as a completed imaging protocol (First-pass MRA (perfusion MRI), steady-state MRA, MR venography) with diagnostic image quality (as determined by the blinded reading)
    Accuracy: Accuracy (sensitivity, specificity, accuracy, PPV, NPV) of MRI for the detection of pulmonary embolism and venous thrombosis compared to the gold standard (CTA and venous ultrasound)
    Total imaging time of MRI (First-pass MRA (perfusion MRI), steady-state MRA, MR venography).
    Subjective image quality of MRI (1=non-diagnostic, 2=poor, 3=moderate, 4=good, 5=excellent).


    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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.8.3 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.8.5.1Number of sites anticipated in the EEA1
    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 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
    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 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 2006-09-20. 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
    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 Decision2007-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-09-18
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