Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2005-000087-12
    Sponsor's Protocol Code Number:DXV406
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-06-08
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2005-000087-12
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, en fase IV, para comparar los efectos renales del medio de contraste no iónico isosmolar, iodixanol 320 mg I/ml (VisipaqueTM), con el medio de contraste no iónico de baja osmolaridad, iopamidol 300 mg I/ml, en sujetos con insuficiencia renal y diabetes mellitus sometidos a TC helicoidal multidetector.
    A.4.1Sponsor's protocol code numberDXV406
    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 Health S.A. (parte de GE Healthcare Ltd y sus filiales)
    B.1.3.4CountrySpain
    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 Visipaque 320 mgI/ml
    D.2.1.1.2Name of the Marketing Authorisation holderAmersham Health S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameVisipaque 320 mg I/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 INNIodixanol
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number320 mg I/ml
    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 No
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Iopamiro 300 mg I/ml
    D.2.1.1.2Name of the Marketing Authorisation holderRovi
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameIopamiro
    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 INNIopamidol
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300 mg I/ml
    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 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 a combination of diabetes mellitus (type I or II), and impaired renal function.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level Pt
    E.1.2Classification code 10061835
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate and compare the effects of two different contrast media, iodixanol 320 mg I/mL and iopamidol 300 mg I/mL, on renal function
    E.2.2Secondary objectives of the trial
    To evaluate and compare the safety profile of iodixanol 320 mg I/mL and iopamidol 300 mg I/mL
    To evaluate and compare the efficacy of iodixanol 320 mg I/mL and iopamidol 300 mg I/mL
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.) The subject is at least 18 years old.
    2.) The subject has diabetes mellitus (type I or II), treated with insulin or oral antidiabetic agents for at least 1 year.
    3.) The subject has a pre-study serum creatinine ≥ 1.7 mg/dl (150 μmol/l) if a man, or ≥ 1.5 mg/dl (133 μmol/l) if a woman,
    or an estimated pre-study glomerular filtration rate (eGFR) ≤ 50 mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) equation.*
    The pre-study serum creatinine value must not be older than 3 months and any acute causes of impaired renal function have to be ruled out.
    * the four-component MDRD equation provides estimates of GFR standardised for body surface, based on the variables serum creatinine concentration (SCr), age, race, and sex:
    eGFR (mL/min/1.73m2) = 186 x SCr-1.154 x age-0.203 (x 0.742 if female) (x 1.210 if black)
    Pre-study serum creatinine has to be expressed in milligrams per decilitre, age in years.
    4.) The subject is referred for a contrast-enhanced MDCT examination, using a standardised CM volume of 1.5 mL per kilogram of body weight and an injection rate of 4 mL/s (in cases with inadequate venous access, a flow of 3 mL/s may be applied). For subjects with a body weight exceeding 100 kilogram, a total CM volume of 150 mL should be administered.
    5.) The subject is a man, or a woman who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (with cessation of menses for more than 1 year), or, if of child-bearing potential, the result of a urine or serum -HCG pregnancy test conducted at screening must be known to be negative before IMP administration.
    6.) The subject is able and willing to comply with study procedures.
    7.) Signed and dated (i.e., date and time) written informed consent is obtained.
    E.4Principal exclusion criteria
    1.) The subject is pregnant or lactating.
    2.) The subject was previously included in this study.
    3.) The subject has received another IMP within 30 days before or is scheduled to receive one within 7 days after IMP administration.
    4.) The subject has received iodinated contrast medium within 7 days before or will receive one within 7 days after IMP administration.
    5.) The subject has a history of serious hypersensitivity reaction to iodinated contrast media.
    6.) The subject has non-compensated heart failure (NYHA III or IV).
    7.) The subject has manifest thyrotoxicosis.
    8.) The subject is in acute renal failure or in acute on chronic renal failure.
    9.) The subject has undergone kidney transplantation.
    10.) The subject is on haemodialysis or peritoneal dialysis.
    11.) The subject has liver cirrhosis with ascites.
    12.) The subject has multiple myeloma.
    13.) The subject is haemodynamically unstable pre-study.
    14.) The subject is scheduled for major surgery within 7 days after IMP administration.
    15.) The subject has received or will receive any of the following potentially nephroprotective drugs from 3 days before until 7 days after IMP administration:
    n-acetylcysteine, fenoldopam, dopamine, or hydration with sodium bicarbonate. Concurrent medication with other drugs that are potentially nephroprotective, like calcium channel blockers or theophylline, are permitted provided they are used for the subject’s underlying disease (e.g., cardiac disease, arterial hypertension, bronchial asthma).
    16.) The subject has received nephrotoxic drugs within 7 days before or will receive such drugs within 7 days after IMP administration. Respective nephrotoxic drugs include antibiotics (e.g., aminoglycosides, vancomycin, amphotericin B), antineoplastic agents (e.g., methotrexate, cisplatin), and immunosuppressants (e.g., cyclosporine).
    17.) The subject has received nonsteroidal anti-inflammatory drugs (NSAID) within 3 days before or will receive such drugs within 7 days after IMP administration, with the exception of low dose aspirin (up to 325 mg per day). However, subjects who are on a stable NSAID regimen may be enrolled.
    18.) The subject has had or is planned to have the initiation, discontinuation, or change in dose of any of the following from 3 days before until 7 days after IMP administration: trimethoprim, cimetidine, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers.

    19.) The subject is on metformin treatment at the time of the study procedure: metformin administration has to be discontinued prior to IMP administration, according to local guidelines, withheld for at least 48 hours, and resumed only if renal function / serum creatinine did not worsen compared to the baseline values.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the incidence rate of contrast-induced nephropathy (CIN), defined as an intra-individual increase in serum creatinine of at least 44.2 µmol/l (0.5 mg/dl) from baseline up to day 3.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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 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
    Last Patient Last Visit (LPLV)
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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 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 2005-06-08. 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 300
    F.4.2.2In the whole clinical trial 500
    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)
    7 days safety follow-up period
    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 Decision2005-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-15
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 10:44:05 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA