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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2006-006946-32
    Sponsor's Protocol Code Number:D5130C00048
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-01
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-006946-32
    A.3Full title of the trial
    A Multi-centre Randomised, Double-blind, Double-dummy Parallel Group Study of the Onset and Offset of the Antiplatelet Effects of AZD6140 Compared with Clopidogrel and Placebo With Aspirin as Background Therapy in Patients with Stable Coronary Artery Disease with Additional Detailed Assessment of Cardiopulmonary Function
    A.4.1Sponsor's protocol code numberD5130C00048
    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, European Regulatory Affairs
    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.3.2Product 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.3.10.3Concentration 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
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pharma Bristol-Myers Squibb SNC
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 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 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
    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
    Arterial thrombosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003178
    E.1.2Term Arterial thrombosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the onset and offset of antiplatelet effect of AZD6140 compared to clopidogrel by evaluation of:
    • The percent inhibition of platelet aggregation (IPA) by light transmittance
    aggregometry (LTA) at 2 hours after 1st dose of study drug
    • The difference in slope of IPA effect curve by LTA after last dose of study drug
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to:
    • Investigate if AZD6140 has any clinically significant cardiopulmonary effect
    compared to clopidogrel and placebo by assessment of cardiopulmonary function
    • Assess safety and tolerability of AZD6140 compared with clopidogrel and placebo
    by evaluation of adverse events, laboratory testing, 12-lead electrocardiogram, vital
    signs and physical examinations
    • To evaluate the pharmacokinetic (PK)/pharmacodynamic (PD) relationship of
    AZD6140 and its active metabolite AR –C124910XX by assessment of PK and PD
    parameters
    • Determine the effect on platelet aggregation of AZD6140 compared to clopidogrel
    with respect to onset and offset by measuring 5 and 20 µM ADP induced platelet
    aggregation
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    All patients enrolled into the main study will be invited to participate in an
    additional genetic research component. Participation is voluntary and requires
    provision of additional informed consent independent of consent to participate in
    the main study. The genetic research component will provide data for possible
    retrospective analysis on the effects of genetic polymorphisms on the response to AZD6140 and clopidogrel, the disposition (absorption, distribution, metabolism and excretion) of AZD6140 and clopidogrel and the susceptibility to and prognosis of coronary artery disease understudy in the main protocol. Any result will not form part of the main study database or the Clinical Study Report. Ethical approval is required for this genetic research component, in addition to, and separate from, the approval for the main study protocol.
    E.3Principal inclusion criteria
    For inclusion in the study patients must fulfil all of the following criteria:
    1. Provision of written informed consent (by patient or appropriate designee according to local regulations)
    2. Documented stable CAD fulfilling any of the following, and taking 75-100mg ASA daily treatment:
    - Stable angina pectoris with objective evidence of CAD
    - Previous MI history
    - Previous revascularization history, (i.e., PCI or coronary artery bypass graft [CABG])
    3. Aged 18 years or older, male or female
    4. Females of childbearing potential (i.e., females who are not post-menopausal or surgically sterile) must:
    - have a negative urine or blood pregnancy test at enrolment and prior to randomisation at Visit 2
    - currently be using a hormonal contraceptive and agree to continue its use in addition to using double-barrier local contraception (i.e., intra-uterine device plus spermicidal and condom for male partner) from screening through study completion.

    For inclusion in the genetic research, patients must sign the informed consent for genetic research.
    E.4Principal exclusion criteria
    Any of the following is regarded as a criterion for exclusion from the study:
    1. Any indication (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve, coronary stent) for antithrombotic treatment (e.g., warfarin, clopidogrel, ASA dose other than 75 to 100 mg daily) during study period
    2. 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
    3. Increased bleeding risk including:
    - Recent (within 30 days) GI bleeding
    - Any history of intracranial, intraocular, retroperitoneal, or spinal bleeding
    - Recent (within 30 days of dosing) major trauma
    - Sustained uncontrolled hypertension (systolic blood pressure [SBP]>180mmHg or diastolic blood pressure [DBP]>100mmHg)
    - History of hemorrhagic disorders that can increase the risk of bleeding, e.g., 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 screening) any oral or parenteral antithrombotic agents (Section 3.7), with the exception of clopidogrel and ASA
    - Platelet count less than 100,000 mm3 or hemoglobin <10 g/dL
    4. History of congestive heart failure, chronic obstructive pulmonary disease, chronic or active asthma, “interstitial lung disease”, other known pulmonary disease that will influence the cardiopulmonary function test interpretation
    5. Diabetic patients with HbA1c≥10%
    6. Contraindication or other reason that clopidogrel, ASA, or AZD6140 should not be administered (e.g., 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 <30mL/min as calculated by the Cockcroft-Gault equation:
    (140-age) x WT
    Creatinine clearance = --------------------------------- (x 0.85 for females)
    72 x serum creatinine

    where WT is weight in kg,
    serum creatinine is in mg/dL
    9. Participation in another investigational drug or device study within 30 days of dosing
    10. Recent (within 30 days of dosing) blood donation
    11. Women who are pregnant or lactating
    12. Patients that are scheduled for revascularization (e.g., PCI, CABG) during the study period
    13. 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 (e.g., active cancer, risk for non compliance, risk for being lost to follow-up)
    14. Patients with raised serum potassium (≥5.5 mmol/L)
    15. Involvement in the planning and conduct of the study (applies to AstraZeneca or delegate staff, ICON staff, and study site staff)
    16. Previous enrolment or randomisation of treatment in the present study
    17. Current smokers, including the use of any tobacco containing products in the past 1 month
    18. Patients who had ACS within 12 months of screening
    19. A suspected/manifested infection according to the World Health Organization (WHO) risk categories 2, 3 and 4 (Appendix C)
    20. Positive test results for Hepatitis B surface antigen (HBsAg) or hepatitis C antibody
    21. AST, ALT, or total bilirubin > 1.5 x upper limit of the reference range.
    22. History of intolerance or allergy to ASA or clopidogrel.
    23. Cardiac ejection fraction <35%; FEV1 or FVC below the lower limit of normal at baseline
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary endpoints are IPA (inhibition of platelet aggregation) at 2 hours after the first dose (final and maximum extent) and the slope of the IPA curves (final and maximum extent) from 4 hours to 72 hours after the last dose.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.8.2.2Placebo Yes
    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 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 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 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
    End of study is defined as database lock, which is the time point after which no patient will be exposed to study-related activities.
    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 months4
    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 months4
    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 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 112
    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)
    After the patient has completed or discontinued the study, they will be treated according to local medical practice. At Visit 10, the investigator may decide what antiplatelet medication the patient should receive as part of their ongoing clinical care following the end of study treatment. This medication will be open label and obtained locally.
    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 Decision2007-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-25
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    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
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