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    The EU Clinical Trials Register currently displays   38596   clinical trials with a EudraCT protocol, of which   6341   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-002809-31
    Sponsor's Protocol Code Number:P04736
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-08-19
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2006-002809-31
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA•CER)
    A.3.2Name or abbreviated title of the trial where available
    TRA•CER
    A.4.1Sponsor's protocol code numberP04736
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorSchering Plough Research Institute, a Division of Schering Corporation
    B.1.3.4CountryUnited States
    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 nameSCH 530348 bisulfate tablet
    D.3.2Product code SCH 530348
    D.3.4Pharmaceutical form 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 705260-08-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 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 nameSCH 530348 bisulfate tablet
    D.3.2Product code SCH 530348
    D.3.4Pharmaceutical form 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 705260-08-8
    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) 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 placeboTablet
    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 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
    Acute Coronary Syndrome
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10051592
    E.1.2Term Acute coronary syndrome
    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 is to evaluate the hypothesis that SCH 530348 added to standard of care will reduce the incidence of atherothrombotic ischemic events relative to standard of care alone, as measured by the composite of cardiovascular (CV) death, myocardial infarction (MI), stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization (revasc).
    E.2.2Secondary objectives of the trial
    Key secondary obj: evaluate benefit with respect to the composite of CV death, MI, and stroke.
    Other secondary efficacy obj: eval incidence of:
    1. CV death, MI , stroke, and urgent coronary revasc
    2. CV death and MI
    3. all-cause death, MI, stroke, recurrent ischemia with rehospitalization, and urgent coronary revasc
    4. all-cause death, MI, stroke and urgent coronary revasc
    5. individual components of composite primary efficacy endpt: CV death, MI, stroke, recurrent ischemia with rehospitalization, urgent coronary revasc
    6. all-cause death.

    Safety obj: eval incidence of:
    1. composite of moderate and severe bleeding events according to GUSTO

    2. "clinically significant bleeding" defined as TIMI major or TIMI minor bleeding, or bleeding that requires unplanned medical or surgical treatment, or lab eval even if it does not meet criteria for TIMI major or TIMI minor bleeding
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject must meet ALL the criteria listed below for entry:
    1. Subject must be 18 years of age or older, and may be of either sex and of any race
    2. Subject must have a current clinical manifestation of NSTEACS according to the following 3 criteria:
    a. history of cardiac-ischemia-related symptoms of at least 10 minutes duration ≤24 hours prior to hospital presentation
    AND
    b. any one (or more) of the following 2 criteria:
    i. concurrent biomarker evidence - elevated troponin I or troponin T greater than the stated upper limit of normal (ULN) at the study site, OR creatine kinase-myocardial band (CK-MB) greater than the ULN at the study site
    ii. concurrent electrocardiographic evidence – electrocardiogram (ECG) changes comprising new or presumably new ST-segment depression ≥0.1 mV (≥ 1 mm), or transient (<30 minutes) ST-segment elevation ≥0.1 mV (≥ 1 mm) in at least two contiguous leads
    AND
    c. any one (or more) of the following 4 criteria:
    i. age ≥ 55 years (Note: Subjects 55 to 59 years will be enrolled so long as the overall occurrence of blinded suspected endpoint events in this age group remains at least a minimum acceptable level as determined by the Executive Committee. Should the occurrence in this age group decrease below a minimum acceptable level as determined by the Executive Committee, the committee may recommend to the sponsor that this age category be removed as a sufficient third criterion for eligibility. Should the sponsor accept the recommendation, investigators would be notified that, moving forward, only age ≥ 60 years would be a sufficient third criterion for eligibility).
    ii. documented prior history of MI or coronary revascularization (PCI or CABG)
    iii. diabetes [documented use of insulin or oral hypoglycemic(s)]
    iv. peripheral arterial disease as indicated by a history of intermittent claudication and either
    a. a resting ankle/brachial index of<0.85, or
    b. amputation, peripheral bypass, or peripheral angioplasty of the extremities
    secondary to ischemia
    3. Subject must be willing and able to give informed consent
    4. A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specified medication, and for 2 months after stopping the medication. Highly effective methods of birth control are defined as those that result in a low failure rate (ie, <1% per year) when used consistently and correctly, such as hormonal implants, injectables, combined oral contraceptives, hormonal intrauterine devices, sexual abstinence, or surgical sterilization (eg, vasectomy of male partner).
    5. A woman of child-bearing potential who is not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the study
    E.4Principal exclusion criteria
    The subject will be excluded from entry if ANY of the criteria listed below are met:
    1. Concurrent or anticipated treatment with warfarin (or derivatives, eg, phenprocoumon), oral factor Xa inhibitor, or oral direct thrombin inhibitor after enrollment. (Note 1: If a subject is taking warfarin during determination of eligibility and the investigator is willing to stop the subject’s treatment with warfarin immediately, and the subject is not otherwise disqualified from participation, then the subject may receive randomized assignment of the study drug). (Note 2: A subject who was not using warfarin/derivatives and for whom use was not anticipated, but who subsequently requires warfarin/derivatives after randomized assignment of study drug may continue treatment with warfarin/derivatives and randomized study drug, except when aspirin/thienopyridine/warfarin concurrent therapy is needed and thienopyridine cannot be discontinued).
    2. Concurrent or anticipated treatment with a potent inducer (eg, rifampin) or potent inhibitor (eg, ketoconazole, erythromycin) of CYP3A4 isoenzymes (detailed list will be supplied to investigator). (Note: A subject who was not using a potent CYP 3A4 inducer or potent inhibitor and/or for whom such therapy was not anticipated, but who subsequently requires such therapy after randomization may receive such therapy as follows:
    a. potent 3A4 inducer – continue study drug until therapy with inducer ends or until
    inducer therapy extends beyond 4 weeks, then discontinue study drug.
    b. potent 3A4 inhibitor – interrupt study drug until inhibitor therapy ends or until
    inhibitor therapy extends beyond 4 weeks, then discontinue study drug).
    3. History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before enrollment
    4. History at any time of intracranial hemorrhage,(except “microhemorrhage”) intracranial or spinal cord surgery, or a central nervous system tumor or aneurysm
    5. Documented sustained severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg) at enrollment or within the previous 10 days
    6. Severe valvular heart disease, as defined by the American College of Cardiology/American Heart Association
    7. History within 2 weeks prior to enrollment of major surgery other than mentioned above or of ischemic (presumed thrombotic) stroke
    8. known history of thrombocytopenia (conventionally defined as platelet count <100,000/mm3) occurring within 30 days before enrollment
    9. Known hepatobiliary disease, or known unexplained persistent increase in serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) activity to two times or more the upper limit of the reference range (upper limit of normal [≥2xULN]) within 30 days before enrollment
    10. Any serious illness or any condition that the investigator feels would (a) pose a significant hazard to the subject if investigational therapy were initiated, or (b) would limit the prognosis of the subject, regardless of investigational therapy
    11. Any serious medical comorbidity (eg, active malignancy) such that the subject's life expectancy is < 24 months
    12. Previous participation in the current study
    13. Current participation in any other study of investigational therapy, or participation in such a study within the last 30 days
    14. Known hypersensitivity to any component of the current investigational product
    15. Subject is a woman who is breast-feeding, pregnant or who intends to become pregnant (affirm that a female subject of child-bearing potential is not pregnant before enrollment).
    16. Subject is part of the staff personnel directly involved with this study, or is a family member of the investigational staff
    17. Known current substance abuse at the time of enrollment
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the first occurrence of any component of the composite of cardiovascular death, MI, stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.3 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA420
    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
    Please see Protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months42
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months42
    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.1.1.1In 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.1.3Elderly (>=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 state350
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7100
    F.4.2.2In the whole clinical trial 12500
    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 Decision2008-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-25
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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