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    Summary
    EudraCT Number:2004-000994-69
    Sponsor's Protocol Code Number:SOV302
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-10-07
    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 ConcernedAustria - BASG
    A.2EudraCT number2004-000994-69
    A.3Full title of the trial
    A multicentre, phase 3, open label study to assess the efficacy and safety of 0.1 mmol/kg Omniscan™ (gadodiamide injection) for Magnetic Resonance Angiography (MRA) of the aorto-iliac arteries
    A.4.1Sponsor's protocol code numberSOV302
    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 SponsorAmersham Buchler GmbH & Co KG an affiliate of GE Healthcare Bio-Sciences
    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 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.2.1.1.1Trade name Omniscan
    D.2.1.1.2Name of the Marketing Authorisation holderAmersham Health Handels GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameOmniscan 0.5mmol/ml
    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 INNGadodiamide
    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) 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 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
    Suspected or proven chronic PAOD predominantly located in the aorto-iliac region of Fontaine Stages IIb to IV (ie, Rutherford Stages I3-III), or presents with an ankle brachial pressure index of <0.70 (measured no more than 3 months prior to screening)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10062585
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of 0.1 mmol/kg OMNISCAN for 3 dimensional contrast-enhanced magnetic resonance angiography (3D CE MRA) compared to 2 dimensional time-of-flight (2D TOF) MRA in the identification of the presence or absence of main haemodynamically relevant stenoses (ie, ≥50% or occlusion) within turbulent flow arteries of the aorto-iliac region. Intra-arterial digital subtraction angiography (IA DSA) will be used as the standard of truth.
    E.2.2Secondary objectives of the trial
    •To determine the efficacy of 0.1 mmol/kg OMNISCAN for 3D CE MRA compared to 2D TOF MRA in the identification of the presence or absence of the main haemodynamically relevant stenosis (ie, ≥50% or occlusion) on a segment to segment level within any of the 7 aorto-iliac arterial segments. IA DSA will be used as the standard of truth.
    •To evaluate the impact of 3D CE MRA findings compared to those of 2D TOF MRA and IA DSA on overall clinical utility on the basis of the consensus decision of a vascular surgeon and a radiologist as to: the occlusion or stenosis requiring the most radical treatment and the recommendation of the most appropriate revascularisation strategy for the lesion (ie, endovascular intervention combined with vascular surgery, vascular reconstructive surgery, endovascular intervention, no revascularisation possible, no revascularisation necessary).

    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    (1)The subject has suspected or proven chronic PAOD predominantly located in the aorto-iliac region of Fontaine Stages IIb to IV (ie, Rutherford Stages I3-III), or presents with an ankle brachial pressure index of <0.70 (measured no more than 3 months prior to screening).
    (2)The subject has been referred to IA DSA for determination of subject management (no more than 1 month prior to inclusion).
    (3)The subject has had no intervention or change of symptoms within the region of interest (ROI) between 3D CE MRA and IA DSA.
    (4)The subject is 18 years or older.
    (5)The subject is conscious and able to comply with study procedures.
    (6)Written and dated (ie, date and time) informed consent is obtained.
    (7)If the subject is a woman of childbearing potential, the results of a serum or urine human chorionic gonadotropin (β-HCG) pregnancy test, done at screening within 24 hours before dosing (with the result known before investigational product administration), must be negative. Only those women who are surgically sterile (have had a documented bilateral oophorectomy and/or documented hysterectomy) or post-menopausal (cessation of menses for more than for more than 1 year) will be allowed to enrol in the study without a pregnancy test at screening.
    E.4Principal exclusion criteria
    (1)The subject has a known hypersensitivity to either conventional X-ray or gadolinium-based MR contrast media including, but not restricted to, the investigational product.
    (2)The subject is lactating.
    (3)The subject is pregnant as defined by a serum or urine β-HCG pregnancy test obtained within 24 hours before administration of the investigational product.
    (4)The subject received or is scheduled to receive MRI contrast medium within 24 hours prior to or less than 24 hours after administration of the investigational product.
    (5)The subject received or is scheduled to receive X-ray contrast medium within 24 hours prior to or less than 24 hours after administration of the investigational product.
    (6)The subject received an investigational product other than OMNISCAN within 30 days prior to OMNISCAN administration or will receive an investigational product within the follow-up period proposed for this study.
    (7)The subject presents any clinically active, serious, life-threatening disease with a life expectancy of less than 6 months.
    (8)The subject has a serum creatinine value of >3.5 mg/dL (309.4 µmol/L).
    (9)The subject has previously been included in this study.
    (10)The subject has a contra-indication for MRI according to accepted clinical guidelines.
    (11) The subject has metal implants and/or stents in the aorto-iliac region and/or hip replacement.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the efficacy of 0.1 mmol/kg OMNISCAN for 3 dimensional contrast-enhanced magnetic resonance angiography (3D CE MRA) compared to 2 dimensional time-of-flight (2D TOF) MRA in the identification of the presence or absence of main haemodynamically relevant stenoses (ie, ≥50% or occlusion) within turbulent flow arteries of the aorto-iliac region. Intra-arterial digital subtraction angiography (IA DSA) will be used as the standard of truth.

    Co-primary endpoints
    The following primary efficacy endpoints will be evaluated simultaneously for each MRA reader:
    (1)Difference in sensitivity between 3D CE MRA and 2D TOF MRA in the identification of the main haemodynamically relevant stenosis (ie, ≥50% or occlusion) on a subject level across the 7 aorto iliac arterial segments with IA DSA as the standard of truth. The main stenosis is defined as the stenosis with the highest grade (ie, percentage decrease in vessel diameter) in one of the 7 vessel segments as determined by the IA DSA blinded image evaluation (BIE).
    (2)Difference in specificity between 3D CE MRA and 2D TOF MRA in the identification of a haemodynamically relevant stenosis (ie, ≥50% or occlusion) based on all of the 7 aorto-iliac arterial segments combined with IA DSA as the standard of truth. All vessel segments across all subjects which are determined to have no haemodynamically relevant stenosis by the IA DSA BIE will be considered for the calculation of specificity.
    The results of 3 independent blinded MRA readers in each subject will be compared separately to the IA DSA findings (read by 2 blinded DSA readers independently - in case of a mismatch between the 2 readers, the readers will be brought together, evaluate the images together and reach consensus).
    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 Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 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 Yes
    E.8.2.3.1Comparator description
    2 D TOF MRA (MRA without contrast)
    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.8.6 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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 Information not present in EudraCT
    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 2004-10-07. 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 192
    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 Decision2004-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
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