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   7294   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:2020-000715-71
    Sponsor's Protocol Code Number:CADET-PAD
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-27
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-000715-71
    A.3Full title of the trial
    The assessment of cysteinyl leukotriene receptor antagonist role in inhibition of atherosclerosis, proliferation and its influence on endothelial
    function in patients undergoing endovascular treatment due to peripheral arterial disease.
    Ocena roli antagonisty receptora leukotrienów cysteinylowych w procesie hamowania miażdżycy i zmian proliferacyjnych oraz jego wpływu na
    funkcje śródbłonka u pacjentów leczonych wewnątrznaczyniowo z powodu miażdżycy zarostowej tętnic kończyn dolnych.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The assessment of cysteinyl leuktriene receptor antagonist (montelukast) role in inhibition of atherosclerosis in patients undergoing endovascular treatment due to peripheral arterial disease.
    Ocena wpływu zastosowania antagonisty receptora leukotrienowego (montelukast) na zahamowanie rozwoju miażdżycy zarostowej tętnic u pacjentów leczonych wewnątrznaczyniowo z powodu niedokrwienia kończyn dolnych
    A.3.2Name or abbreviated title of the trial where available
    CADET-PAD
    CADET-PAD
    A.4.1Sponsor's protocol code numberCADET-PAD
    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 SponsorJagiellonian University Medical College
    B.1.3.4CountryPoland
    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 supportNational Science Centre
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJagiellonian University Medical College
    B.5.2Functional name of contact pointClinical Trial Office
    B.5.3 Address:
    B.5.3.1Street Addressul. Podwale 3/6
    B.5.3.2Town/ cityKraków
    B.5.3.3Post code31-118
    B.5.3.4CountryPoland
    B.5.4Telephone number+4812 12 370 43 30
    B.5.6E-mailbadania.kliniczne@uj.edu.pl
    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 Asmenol
    D.2.1.1.2Name of the Marketing Authorisation holderZakłady Farmaceutyczne POLPHARMA SA
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 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 INNmontelukast
    D.3.9.1CAS number 158966-92-8
    D.3.9.3Other descriptive nameMONTELUKAST SODIUM
    D.3.9.4EV Substance CodeSUB03324MIG
    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
    Occlusive atherosclerosis in patients treated endovascularly due to ischemia of the lower limbs in the course of obstructive artery disease.
    Miażdżyca zarostowa tętnic u pacjentów leczonych wewnątrznaczyniowo z powodu niedokrwienia kończyn dolnych w przebiegu miażdżycy zarostowej tętnic.
    E.1.1.1Medical condition in easily understood language
    Ischemia of the lower limbs in the course of obstructive artery disease
    Niedokrwienie kończyn dolnych w przebiegu miażdżycy tętnic kończyn dolnych.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10067825
    E.1.2Term Peripheral arterial disease
    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
    The main goal of this study is to investigate the influence of the use of cysteinyl leukotrienes receptor antagonists on lower limbs arteries reocclusion rate in patients with peripheral artery occlusive disease (PAOD) after endovascular treatment.
    Ocena wpływu zastosowania antagonisty receptora leukotrienowego (montelukast) na zahamowanie rozwoju miażdżycy zarostowej tętnic u pacjentów leczonych we-wnątrznaczyniowo z powodu niedokrwienia kończyn dolnych.
    E.2.2Secondary objectives of the trial
    Assessment of the improvement in the quality of life patients treated endovascularly for ischemia of the lower limbs caused by the use of a leukotriene receptor antagonist (montelukast).
    Ocena poprawy jakości życia pacjentów leczonych wewnątrznaczyniowo z powodu niedokrwienia kończyn dolnych pod wpływem zastosowania antagonisty receptora leukotrienowego (montelukast).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ✓ Patients with PAOD qualified for PTAvin the Angiology Department UJ CM, with Rutherford 3 or 4 clinical symptoms.
    ✓ Age 45 - 75 years old.
    ✓ Signed informed consent.
    ✓ Citizen of Malopolska region
    1. Wyrażenie świadomej pisemnej zgody na udział w badaniu
    2. Zakwalifikowanie do zabiegu endowaskularnego udrożnienia lub poszerzenia tętnic kończyn dolnych
    3. Miażdżyca zarostowa w stadium III lub IV Klasyfikacji Rutherforda
    4. Wiek 45-75 lat
    E.4Principal exclusion criteria
    ✓ Patients with peripheral arterial disease (PAOD) with Rutherford 1,2,5 or 6 clinical symptoms.
    ✓ Age < 45 or > 75 years old.
    ✓ Infection and/or fever (temperature above 37,2 C) within the last 3 weeks preceding the study recruitment (viral infections, cold, sinusitis) and use of antibiotics within the last 2 months.
    ✓ Symptoms of acute tissue infection
    ✓ Chronic inflammatory disease (e.g. COPD stage >II in GOLD classification)
    ✓ HIV+, HCV+, HBS+.
    ✓ Autoimmunological diseases and use of steroids or immunosuppressive medications within the last 3 months.
    ✓ Inflammatory blood vessel disorders (with exception of atherosclerosis)
    ✓ Myocardial infarction or stoke within last 6 months.
    ✓ Buerger Disease.
    ✓ Chronic heart failure (3-4 NYHA)
    ✓ Acute lower limb ischemia or surgical revascularization within last 6 months.
    ✓ Serious trauma or surgery procedure within last 6 months.
    ✓ Asthma.
    ✓ On-going antileukotriene treatment.
    ✓ Neoplasm diagnosed within 5 years.
    ✓ Chronic Kidney Disease (creat. >177 μmol/l).
    ✓ Pregnancy, puerperium, women without efficient contraception.
    ✓ Vaccinations within 30 days before recruitment.
    ✓ Hospitalisation in intensive care unit within 3 months.
    ✓ Lack of the possibility of the follow-up participation.
    1. Miażdżyca zarostowa kończyn dolnych w stadium I, II, V lub VI Klasyfikacji Rutherforda
    2. Infekcja lub przeziębienie (temperatura ciała powyżej 37,2oC, objawy przeziębienia, infekcji wirusowej lub zapalenia zatok) w przeciągu do 3 tygodni poprzedzających hospitalizację
    3. Stosowanie antybiotyków do 2 miesięcy poprzedzających hospitalizację
    4. Objawy stanu zapalnego tkanek
    5. Przewlekłe choroby zapalne
    6. Przewlekła Obturacyjna Choroba płuc (stadium wyższe niż II w klasyfikacji GOLD)
    7. Astma
    8. Infekcja HIV, HCV, HBS
    9. AIDS
    10. Choroby autoimmunologiczne
    11. Stosowanie leków sterydowych lub immunosupresyjnych w ciągu 3 miesięcy poprzedzających hospitalizację
    12. Stosowanie leków antyleukotrienowych
    13. Choroby zapalne naczyń za wyłączeniem miażdżycy zarostowej tętnic
    14. Zawał mięśnia sercowego w ciągu 6 miesięcy poprzedzających hospitalizację
    15. Choroba Buergera
    16. Przewlekła niewydolność serca (klasa III i IV w klasyfikacji NYHA)
    17. Ostre niedokrwienie kończyny dolnej
    18. Poważny uraz wymagający interwencji chirurgicznej lub operacja chirurgiczna w ciągu 6 miesięcy poprzedzających hospitalizację
    19. Choroba nowotworowa zdiagnozowana w ciągu 5 lat poprzedzających hospitalizację
    20. Przewlekła niewydolność nerek (Kreatynina >177 µmol/l)
    21. Ciąża, połóg, karmienie piersią lub niewystarczająca antykoncepcja u kobiet nadal miesiączkujących
    22. Szczepienie w ciągu 30 dni poprzedzających hospitalizację
    23. Hospitalizacja w oddziale intensywnej terapii w ciągu 3 miesięcy poprzedzających hospitalizację
    24. Uczestnictwo w innych programach badaniach klinicznych w okresie do 6 miesięcy poprzedzającym wyrażenie zgody na udział w niniejszym badaniu
    E.5 End points
    E.5.1Primary end point(s)
    Restenosis in a previously treated artery
    Restenoza w leczononej uprzednio tętnicy
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 3, 6, 9 and 12 months from patient enrollment
    1, 3, 6, 9 i 12 miesięcy od daty włączenia do badania
    E.5.2Secondary end point(s)
    MACE, high lower limb amputation, significant loss in quality of life
    MACE, wysoka amputacja kończyny dolnej, znaczący ubytek w jakości życia
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3, 6, 9 and 12 months from patient enrollment
    1, 3, 6, 9 i 12 miesięcy od daty włączenia do badania
    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 Yes
    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 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 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.8.5The 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
    LVLS
    Ostatnia wizyta ostatniego pacjenta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state200
    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)
    None
    brak
    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 Decision2021-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-20
    P. End of Trial
    P.End of Trial StatusOngoing
    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-Tue May 14 17:09:50 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA