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    The EU Clinical Trials Register currently displays   35213   clinical trials with a EudraCT protocol, of which   5757   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-005305-19
    Sponsor's Protocol Code Number:D5130C00030
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-25
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2008-005305-19
    A.3Full title of the trial
    A Randomised, Double-Blind, Outpatient, Crossover Study of the Anti-platelet Effects of AZD6140 Compared with Clopidogrel in Patients with Stable Coronary Artery Disease Previuosly Identified as Clopidogrel Non-responders or Responders [RESPOND]
    A.3.2Name or abbreviated title of the trial where available
    RESPOND
    A.4.1Sponsor's protocol code numberD5130C00030
    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 SponsorAstraZeneca 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 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 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 nameTicagrelor
    D.3.2Product code AZD6140
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNticagrelor
    D.3.9.1CAS number 274693-27-5
    D.3.9.2Current sponsor codeAZD6140
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 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 Yes
    D.2.1.1.1Trade name Plavix 75 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pharma Bristol-Myers Squibb SNC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameclopidogrel
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNclopidogrel
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Stable Coronary Artery Disease

    AZD6140 is under development for the prevention of thrombotic events in patients with non-ST and ST elevation coronary syndromes
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLT
    E.1.2Classification code 10011085
    E.1.2Term Ischaemic coronary artery disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the effect of AZD6140 on inhibition of platelet aggregation compared with clopidogrel in patients previously identified as non-responsive to clopidogrel
    E.2.2Secondary objectives of the trial
    ¤ compare inhibition of platelet aggregation (IPA), platelet aggregation and biomarker expression in clopidogrel responsive patients when directly switched from clopidogrel to AZD6140, as opposed to continuing treatment with clopdogrel without interruption
    ¤ compare IPA, platelet aggregation and biomarker expression in clopidogrel responsive patients when directly switched from AZD6140 to clopidogrel, as opposed to continuing treatment with AZD6140 without interruption
    ¤ assess the general tolerability of a direct swith from clopidogrel to AD6140 without a washout
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    CSP Appendix D
    The genetic component of this study is optional for study sites as well as for individual subjects.
    Objectives are to obtain DNA samples for future exploratory research on the effects of genetic polymorphisms on:
    ¤ response to AZD6140 and clopidogrel
    ¤ disposition (absorption, distribution, metabilism and excretion) of AZD6140 and clopidogrel
    ¤ susceptibility to and prognosis of coronary artery disease under study in main protocol

    2, CSP Appendix F UK Radioligand Sub study
    Applicable for UK site only.
    Objective is to obtain pilot data for studying whether AZD6140 affects the binding of Clopidogrel active metabolite to the P2Y 12 receptor.
    E.3Principal inclusion criteria
    1, Provision of written informed consent
    2, Documented stable CAD fulfilling any of the following, and taking ASA daily treament for at least 1 month prior to receiving their first dose of study medication: stable angina pectoris with objective evidence of CAD, previous myocardial infarction history, previous revascularisation history
    3, Aged 18 years or older, male or female
    4, Females of childbearing potential must: have a negative urine or blood pregancy test at enrolment, currently be using a hormonal contraceptive and agree to continue its use in addition to using barrier local contraception from screening through stuy completion. Women not using hormonal contraception must use double barrier local contraception

    Genetic substudy
    Provide written informed consent

    Radioligand substudy
    Provide written informed consent
    E.4Principal exclusion criteria
    1. Patients who had ACS within 12 months of screening
    2. Any of the following requiring antithrombotic treatment (eg, warfarin, clopidogrel,
    ASA dose other than 75 mg to 100 mg daily) during the study period: atrial
    fibrillation, mitral stenosis or prosthetic heart valve, coronary stent
    3. Concomitant therapy with moderate or strong CYP3A inhibitors, CYP3A substrates
    with narrow therapeutic index, or strong CYP3A inducers within 14 days of study
    treatment. For example:
    Moderate inhibitors: Amprenavir, aprepitant, diltiazem, erythromycin, fluconazole,
    fosamprenavir, grapefruit juice, verapamil
    Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin,
    clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir.
    Substrates with narrow therapeutic index: cyclosporine, quinidine.
    Strong inducers: rifampin/rifampicin, phenytoin, carbamazepine.
    The sponsor should be consulted for enrollment with any concomitant medicines
    which are suspected of undergoing moderate/strong drug-drug interaction
    4. Increased bleeding risk including:
    Gastrointestinal (GI) bleeding within 30 days of dosing
    Any history of intracranial, intraocular, retroperitoneal, or spinal bleeding
    Major trauma within 30 days of dosing
    Sustained uncontrolled hypertension (systolic blood pressure [SBP] >180 mmHg or
    diastolic blood pressure [DBP] >100 mmHg)
    History of hemorrhagic disorders that can increase the risk of bleeding,
    eg, haemophilia, von Willebrand’s disease
    Inability to discontinue required concomitant therapy with non-selective
    non-steroidal anti-inflammatory drug (NSAID) at screening
    Patients that have recently used within 30 days of dosing any oral or parenteral
    antithrombotic agents, with the exception of clopidogrel and ASA.
    Platelet count less than 100,000 mm3 or hemoglobin (Hb) <10 g/dL
    5. Diabetic patients with glycated Hb (HbA1c)≥10%
    6. Contraindication or other reason that clopidogrel, ASA, or AZD6140 should not be
    administered (eg, hypersensitivity, active bleeding, major surgery within 30 days of
    dosing, any bleeding tendency [coagulation defects], acute or chronic liver disease
    etc.)
    7. History of drug addiction or alcohol abuse in the previous 2 years
    8. Patient requires dialysis or has a creatinine clearance (CLCR) <30 mL/min as
    calculated by the Cockcroft-Gault equation.
    9. Participation in another investigational drug or device study within 30 days of
    dosing
    10. Current smokers using more than 1 pack per day (or equivalent) of any tobacco
    containing products in the past 1 month
    11. Recent (within 30 days of dosing) blood donation
    12. Women who are pregnant or lactating
    13. Patients that are scheduled for revascularization (eg, PCI, CABG) during the study
    period
    14. Any acute or chronic unstable condition in the past 30 days or other condition
    which, in the opinion of the investigator, may either put the patient at risk or
    influence the result of the study (eg, active cancer, risk for non-compliance, risk for
    being lost to follow-up)
    15. Patients with raised serum potassium (≥5.5 mmol/L)
    16. Involvement in the planning and conduct of the study (applies to AstraZeneca or
    delegate staff, and study site staff)
    17. Previous enrolment or randomisation of treatment in the present study
    18. A suspected/manifested infection according to the World Health Organization
    (WHO) risk categories 2, 3 and 4
    19. Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody,
    or human immunodeficiency virus (HIV) antibody
    20. Aspartate amino transferase (AST), alanine amino transferase (ALT), or total
    bilirubin > 1.5 x upper limit of the reference range.
    21. History of intolerance or allergy to ASA or clopidogrel. Patients previously
    desensitized to ASA are not considered currently allergic and are eligible to
    participate.

    Genetic substudy
    The patient should be excluded from this part if a previous bone marrow transplant has been performed

    Radioligand substudy
    Patients who have discontinued study medication prior to the first blood sampling assessment
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacodynamic
    Primary outcome variables:
    - Proportion of clopidogrel non-responders who respond to antiplatelet therapy
    as measured by 20 μM IPA (final extent) at 4 hours post dose at steady state.
    The primary definition of response to treatment in this trial is IPA > 10%.
    Pharmacokinetic
    Exploratory analyses of PK/PD relationships between AZD6140 plasma
    concentrations and pharmacodynamic parameters may be conducted.

    Safety
    Safety will be assessed via the following variables: adverse events (including
    bleeding events), safety labs (clinical chemistry, haematology and urinalysis),
    12-lead electrocardiograms, physical examination and vital signs (blood pressure,
    pulse and respiratory rate).

    Genetics
    The genetic research component will provide data for retrospective analysis.
    Any result will not form part of the main study database or the Clinical Study
    Report.

    Radioligand
    Pilot data for studying whether AZD6140 affects the binding of clopidogrel active metabolite to the P2Y 12 receptor.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 No
    E.8.1.6Cross over Yes
    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.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    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 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 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
    Database locked, which is the time point after which no patient will be exposed to study related activites
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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 2008-09-25. 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Informed consent could be provided by appropriate designee according to local regulations.
    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 80
    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)
    The investigator will decide which currently approved anti-platelet medication therapy the patient should receive as part of the ongoing clinical care, until they are seen by their regular health care provider and this transition information will be recorded.
    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 Decision2008-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-20
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