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    The EU Clinical Trials Register currently displays   44020   clinical trials with a EudraCT protocol, of which   7318   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:2004-000352-16
    Sponsor's Protocol Code Number:D5130C00002
    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:2005-02-08
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-000352-16
    A.3Full title of the trial
    A Double-blind, Double-dummy, Parallel Group Randomised Dose Confirmation and Feasibility Study of AZD6140 + Acetyl Salicylic Acid (ASA) Compared with Clopidogrel + ASA in Patients with Non-ST Segment Elevation Acute Coronary Syndromes - DISPERSE2 - TIMI33
    A.3.2Name or abbreviated title of the trial where available
    DISPERSE 2 TIMI 33
    A.4.1Sponsor's protocol code numberD5130C00002
    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 Information not present in EudraCT
    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.3.9.1CAS 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 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 Information not present in EudraCT
    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 Plavix 75 mg film coated tablets
    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 namePlavix 75 mg film coated tablets
    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 INNclopidogrel hydrogen sulphate
    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 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 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
    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
    Non-ST Segment Elevation Acute Coronary Syndromes
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10051592
    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 assess the safety and tolerability of different doses of AZD6140 in the presence of acetyl salicylic acid (ASA), compared with clopidogrel plus ASA in patients with non-ST segment elevation ACS by evaluation of total bleeding events (excluding minimal bleeds) observed within the first 4 weeks of treatment (Day 29).
    E.2.2Secondary objectives of the trial
    ·To assess the pharmacodynamic effects of AZD6140 in the presence of ASA compared to clopidogrel plus ASA (in clopidogrel-naïve patients).
    ·To compare the platelet aggregation response to AZD6140 on Day 1 in clopidogrel-naïve patients and clopidogrel pre-treated patients.
    ·To evaluate the pharmacokinetics of AZD6140 and its active metabolite AR-C124910XX.
    ·To evaluate the relationship between AZD6140 pharmacokinetics and platelet aggregation inhibition.
    ·To evaluate the relationship between AZD6140 and AR-C124910XX exposures and the occurrence of major and minor bleeding.
    ·To compare the safety and tolerability of AZD6140/ASA with clopidogrel/ASA.
    ·To assess the safety and tolerability of the AZD6140 loading dose.
    ·To evaluate the effect of AZD6140 on the inflammatory markers and comparing the changes to those achieved with clopidogrel.
    ·
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Non-ST segment elevation ACS (index event) within the previous 48 hours documented by ischaemic symptoms of >10 minutes’ duration at rest, plus at least one of the following criteria described in either a or b:
    a. Biochemical marker evidence of MI:
    - Troponin T or I > local MI decision limit on at least one occasion during the first 24 hours after admission for the index clinical event.
    - CK-MB, preferably CK-MB mass, >local MI decision limit on at least one occasion during the first 24 hours after admission for the index clinical event.
    - In the absence of troponin or CK-MB, total CK >2x local MI decision limit during the first 24 hours after admission for the index clinical event.
    b. ECG changes indicative of ischaemia:
    - ST segment depression >0.5 mm (0.05 mV) in 2 or more contiguous leads.
    - Transient ST segment elevation <20 mins, >1 mm (0.1 mV) in 2 or more contiguous leads.
    - T-wave abnormalities - inversion >1 mm (0.1 mV) in 2 or more contiguous leads.
    2. Provision of written informed consent.
    3. Females and males aged 18 years and over.
    E.4Principal exclusion criteria
    1. Persistent ST segment elevation >20 minutes.
    2. More than 48 hours from onset of symptoms of non-ST segment elevation ACS to expected initiation of therapy (first dose).
    3. PCI within the 48 hours prior to the index event or PCI within the 48 hours prior to randomisation.
    4. Coronary angiography in the 48 hours prior to randomisation showing no significant narrowing of the coronary arteries or <50% diameter stenosis.
    5. Any of the following conditions associated with increased risk of bleeding:
    a. History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding.
    b. Gastrointestinal bleeding within the 6 months prior to randomisation.
    c. Gastric or duodenal ulcer disease verified by endoscopy or barium meal contrast technique within the 6 months prior to randomisation.
    d. Persistent uncontrolled hypertension: systolic >180 mmHg or diastolic >100 mmHg with or without anti-hypertensive treatment (as demonstrated by repeated BP measurements >180/100 mmHg including the final BP measurement before randomisation).
    e. Haemorrhagic disorder.
    f. Major surgical procedure or trauma within the 30 days prior to randomisation.
    g. Intracranial aneurysm or vascular malformation.
    6. Chronic oral anticoagulation required eg, atrial fibrillation, mitral stenosis, rheumatic valve disease, prosthetic heart valves; or concomitant oral anticoagulation therapy within the 7 days prior to randomisation.
    7. Chronic daily dosing with non-selective NSAIDs required eg, rheumatoid arthritis.
    8. Thrombolytic therapy administered for STEMI or any other condition in the 7 days prior to randomisation.
    9. Contraindications for ASA treatment, including allergy or intolerance that would prevent its use during the study.
    10. Concomitant therapy with digoxin or strong cytochrome P450 3A4 inhibitors or cytochrome P450 3A4 substrates with a narrow therapeutic index.
    11. Known lactose intolerance.
    12. Serum creatinine level >3.0 mg/dL (265 mmol/L).
    13. Known active liver disease or Visit 1 elevated liver function tests of ALT >2x ULN or total bilirubin >1.5x ULN (local laboratory reference ranges).
    14. Haemoglobin (Hb) level <100 g/L (6.2 mmol/L).
    15. Platelet count <100x109/L.
    16. CABG within the 3 months prior to randomisation.
    17. Non-haemorrhagic stroke within the 30 days prior to randomisation.
    18. Active cancer (excluding skin basal cell carcinoma).
    19. Female of childbearing potential (female patients must be either post-menopausal for 1 year, or surgically sterile).
    20. Patients with disease or disorders which in the opinion of the investigator, may either put the patient at risk because of participation in the study or inappropriately influence the result of the study, or the patient’s ability to participate in the study.
    21. Inability to complete the study according to the protocol, eg, inability to complete questionnaires in local language.
    22. Participation in another investigational drug study within one month prior to randomisation or previous randomisation in this study.
    23. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site).
    24. Previous enrolment or randomisation of treatment in the present study.

    - Additional exclusion criteria for patients participating in the PK/PD sub-study:

    25. Concomitant treatment with GpIIb/IIIa receptor antagonists within 24 hours (tirofiban, integrilin) or 7 days (abciximab) prior to randomisation.
    26. Concomitant treatment with unfractionated heparin (UFH) within the 12 hours prior to randomisation.
    27. Concomitant treatment with dipyridamole within the 24 hours prior to randomisation.
    28. *Chronic treatment with clopidogrel, or receipt of clopidogrel in the 10 days prior to randomisation.
    E.5 End points
    E.5.1Primary end point(s)
    Total bleeding events (excluding minimal bleeds) observed within the first four weeks of treatment
    Total bleeding events (excluding minimal) at Days 57 and 85, plus overall bleeding rate using total patient exposure
    Each individual bleeding category (excluding minimal), separately
    Discontinuations due to bleeding adverse events
    Bleeding (excluding minimal) associated with coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) vs bleeding (excluding minimal) not associated with CABG or PCI
    Number of transfusions, categorised as 1 unit, 2-3 units or equal to or more than 4 units.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    double dummy
    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 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 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
    End of study is defined as date of database lock which is the timepoint 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 years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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 No
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 590
    F.4.2.2In the whole clinical trial 990
    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 Decision2004-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-06-03
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