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   43874   clinical trials with a EudraCT protocol, of which   7293   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:2011-000285-35
    Sponsor's Protocol Code Number:Cardoz-003
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-03-21
    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 ConcernedSweden - MPA
    A.2EudraCT number2011-000285-35
    A.3Full title of the trial
    An international, multi-centre, randomised, stratified, double-blinded,
    placebo-controlled, 4-parallel group trial investigating the efficacy and safety
    of three different dose levels of CRD007 administered twice daily for 1 year
    to subjects with AAA (The AORTA trial).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international multi-centre one-year trial of effects and side-effects of CRD007 tablets for treatment of aneurysm (dilation) of the aorta (the largest artery in the body) in the abdominal cavity.
    A.3.2Name or abbreviated title of the trial where available
    CRD007 for the treatment of AAA
    A.4.1Sponsor's protocol code numberCardoz-003
    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 SponsorCardoz AB
    B.1.3.4CountrySweden
    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 supportCardoz AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCardoz AB
    B.5.2Functional name of contact pointCEO
    B.5.3 Address:
    B.5.3.1Street AddressKornhamnstorg 53/Box 2077
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post codeSE-102 13
    B.5.3.4CountrySweden
    B.5.4Telephone number+3670975 98 63
    B.5.5Fax number+468566 300 13
    B.5.6E-mailcarl-johan.dalsgaard@ofco.se
    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 No
    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 namepemirolast
    D.3.2Product code CRD007
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEMIROLAST
    D.3.9.1CAS number 69372-19-6
    D.3.9.2Current sponsor codeCRD007
    D.3.9.4EV Substance CodeSUB09656MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.IMP: 2
    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 No
    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 namepemirolast
    D.3.2Product code CRD007
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEMIROLAST
    D.3.9.1CAS number 69372-19-6
    D.3.9.2Current sponsor codeCRD007
    D.3.9.4EV Substance CodeSUB09656MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 3
    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 No
    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 namepemirolast
    D.3.2Product code CRD007
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEMIROLAST
    D.3.9.1CAS number 69372-19-6
    D.3.9.2Current sponsor codeCRD007
    D.3.9.4EV Substance CodeSUB09656MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Abdominal aortic aneurysm (AAA) is a dilatation of the aorta as it passes through the
    abdomen, defined as a dilatation of the infra-renal aorta to a diameter of 30 mm. AAA is
    generally asymptomatic and the greatest concern is the risk of rupture, which causes severe
    pain, massive internal hemorrhage, and, without prompt treatment, death.
    E.1.1.1Medical condition in easily understood language
    Abdominal aortic aneurysm (AAA) is generally asymptomatic and the greatest concern is the risk of rupture, which causes severe pain, massive internal hemorrhage, and, without prompt treatment, death.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10000054
    E.1.2Term Abdominal aortic aneurysm
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the optimal oral dose of CRD007 (10 mg, 25 mg and 40 mg tablets) in
    comparison to matching placebo tablets with respect to efficacy in terms of change in
    maximum aortic diameter after 12 months of treatment (b.i.d.) as assessed by
    measurement method A (based on measurement perfromed during systole).
    E.2.2Secondary objectives of the trial
    • To compare CRD007 (10 mg, 25 mg and 40 mg tablets) to matching placebo tablets with respect to efficacy in terms of change in maximum aortic diameter after 12 months of treatment (b.i.d.) as assessed by measurement method A (based on measurement performed during diastole)

    - To compare CRD007 (10 mg, 25 mg and 40 mg tablets) to matching placebo tablets with respect to efficacy in terms of change in maximum aortic diameter after 12 months of treatment (b.i.d.) as assessed by measurement method B
    • To compare CRD007 (10 mg, 25 mg and 40 mg tablets) to matching placebo tablets with respect to efficacy in terms of change in maximum aortic diameter after 6 months of
    treatment (b.i.d.) as assessed by measurement method A and B
    • To compare CRD007 (10 mg, 25 mg and 40 mg tablets) to matching placebo tablets with
    respect to efficacy in terms of incidence and time to maximum aortic diameter of 50 mm
    as assessed by measurement method A and B
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Infrarenal abdominal aortic aneurysm with a maximum diameter between ≥39 mm and
    ≤49 mm4
    2. Age ≥50 years
    3. Following receipt of verbal and written information about the trial, the subject has
    provided signed informed consent before any trial related activity is carried out
    E.4Principal exclusion criteria
    1. Previous infra-renal aortic surgery
    2. Planned major surgery
    3. Known aortic dissection
    4. Known diabetes
    5. Treatment with systemic corticosteroids or any other systemic immunomodulatory therapy
    6. Known or suspected inherited connective tissue disorders (i.e. Marfan or Vascular Ehlers
    Danlos syndrome)
    7. Calculated CLCR < 30 ml/min5
    8. Known significant liver disease (e.g. acute clinical hepatitis, chronic active hepatitis or
    ALT >3 x the ULN6)
    9. Known HIV infection at the time of screening
    10. Serious concomitant illness associated with a life expectancy less than 2 years
    11. Active severe infection, any other concurrent disease or medical conditions that are
    deemed to interfere with the conduct of the trial as judged by the investigator
    12. Clinically significant cardiac disease including unstable angina, acute myocardial
    infarction within six months from screening and congestive heart failure (NYHA III-IV
    according to the New York Heart Association (NYHA) functional classification system)
    13. Significant concurrent, uncontrolled medical condition including, but not limited to, renal,
    hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or
    psychiatric disease evaluated by the investigator to interfere with effect of the trial drug
    14. Subjects known or suspected of not being able to comply with this trial protocol (e.g. due
    to alcoholism, drug dependency or psychological disorder)
    15. Receipt of prior experimental agents within 30 days prior to screening
    16. Current participation in any other interventional clinical trial
    17. Subjects with known uncontrolled allergic conditions or allergy/hypersensitivity to any
    component of the trial drug or placebo excipients
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change in maximum aortic diameter from screening (Visit 1) to 12 months of
    treatment (Visit 7) as assessed by measurement method A.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is evaluated after 12 months of treatment
    E.5.2Secondary end point(s)
    • Absolute change in maximum aortic diameter from screening (Visit 1) to 12 months of
    treatment (Visit 7) as assessed by measurement method B3
    • Absolute change in maximum aortic diameter from screening (Visit 1) to 6 months of
    treatment (Visit 5) as assessed by both measurement method A and B3
    • Incidence and time to maximum aortic diameter of 50 mm as assessed by measurement
    method A and B3
    • Incidence and time to clinical events of special interest
    - Acute or elective aneurysm repair
    - Aneurysm rupture
    - Major cardiovascular events
    - Other clinical events of special interest
    - Death (any cause)
    • Biomarkers
    • Adverse events
    • ECG assessments
    • Blood pressure and pulse
    • Haematology, serum chemistry and liver function parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    •The evaluation of change in maximum aortic diameter after 6 and 12 months of treatment
    • Incidencee and time to clinical event: any time during the treatment
    • Biomarkers: after 12 months treatment
    • Adverse events: at each clinical visit (week 1, 13, 26, 39 and 52 of treatment)
    • ECG assessment: after 12 months treatment
    • Blood pressure and pulse: at each clinical visit (week 1, 13, 26, 39 and 52 of treatment)
    • Haematology, serum chemistry and liver function parameters: after 13, 26, 39 and 52 weeks treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    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 Yes
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 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
    The end of the trial is defined as the date of last subject 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 months7
    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 months7
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 270
    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 No
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    IMP will not be available to the subject after end of treatment. After trial completion the investigator must ensure other treatment according to local clinical practice.
    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 Decision2011-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-11
    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-Wed May 08 21:52:10 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA