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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
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    The EU Clinical Trials Register currently displays   43861   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:2008-004881-16
    Sponsor's Protocol Code Number:P05633
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-004881-16
    A.3Full title of the trial
    The Effect of Acadesine on Clinically Significant Adverse Cardiovascular and Cerebrovascular Events in High-Risk Subjects Undergoing Coronary Artery Bypass Graft (CABG) Surgery Using Cardiopulmonary Bypass (Protocol No. P05633): RED-CABG Trial (Reduction in Cardiovascular Events by Acadesine in Subjects Undergoing CABG)
    A.3.2Name or abbreviated title of the trial where available
    RED-CABG Trial
    A.4.1Sponsor's protocol code numberP05633
    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 nameAcadesine Powder for Injection
    D.3.2Product code SCH 900395
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAcadesine
    D.3.9.1CAS number 2627-69-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number526.5
    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 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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Coronary artery disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10011078
    E.1.2Term Coronary artery disease
    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 clinical benefit of acadesine in reducing the incidence of ischemia-reperfusion injury resulting from Coronary Artery Bypass Graft (CABG) surgery, as measured by the first occurrence of any component of the composite primary endpoint of all-cause death, non-fatal stroke, or need for mechanical support for severe left ventricular dysfunction (SLVD) occurring during or following CABG surgery through Postoperative Day (POD) 28.
    E.2.2Secondary objectives of the trial
    The key secondary objective is to evaluate the clinical benefit of acadesine with respect to incidence of the first occurrence of any component of the composite of cardiovascular death, non-fatal stroke, or need for mechanical support for SLVD occurring during or following CABG surgery through POD 28.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject must meet ALL the criteria listed below for entry:
    1. A subject must be a high-risk patient undergoing non-emergency CABG surgery requiring cardiopulmonary bypass and cardioplegia.

    2. A subject must be ≥ 50 years of age.

    3. A subject must have at least one of the following risk factors:
    a. Female (but not pregnant or lactating), or
    b. History of prior CABG, or
    C. History of MI (except for MI within 5 days prior to surgery or MI having occurred more than 2 years previously), or
    d. History of ischemic stroke, or
    e. Left ventricular ejection fraction (LVEF)≤30% (measured any time within the previous 3 months before Screening by any clinically acceptable imaging modality), or
    f. Diabetes mellitus requiring insulin and/or antidiabetic agents.

    4. A subject must have demonstrated on coronary angiography, performed within the past 12 months, to have significant coronary artery stenosis of at least 50% of the left main coronary artery, or 70% or more of three coronary arteries, or 70% or more of two coronary arteries inclusive of the left anterior descending (LAD). The screening coronary angiography must have been performed after any previous PCI or CABG.

    5. A subject must be willing and able to give Informed Consent.

    6. A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception during screening and for one month after stopping the medication.

    Medically accepted methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), inert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation).

    Postmenopausal women are not required to use contraception. Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period.

    7. While participation in pharmacogenomic and biomarker testing is optional, a subject must be willing to give written informed consent for pharmacogenomic and biomarker testing in order for the tests to be performed. A subject who is unwilling to sign the informed consent for pharmacogenomic testing may be included in the trial; however, pharmacogenomic and biomarker samples must not be obtained.
    E.4Principal exclusion criteria
    The subject will be excluded from entry if ANY of the criteria listed below are met:

    1. Subject undergoing planned valve replacement, carotid artery or aortic surgery, distal coronary endarterectomy, surgical ablation for cardiac arrhythmia, or ventricular aneurysmectomy, alone or with CABG surgery (repair for mild-to-moderate mitral valve disease with concomitant CABG is not excluded).

    2. Subject with planned or staged major surgery within 30 days of CABG surgery (eg, aortic aneurysm, abdominal, thoracic).

    3. Subject undergoing CABG surgery using intermittent aortic cross clamping without cardioplegia.

    4. Subject undergoing minimally invasive surgery (ie, without use of cardiopulmonary bypass).

    5. Subject with an MI within 5 days prior to surgery.

    6. Subject with a pre-operative or planned intra-operative/postoperative use of intra-aortic balloon pump (IABP), ventricular assist device (VAD), extra-corporeal membrane oxygenator (ECMO), or other mechanical hemodynamic assist device.

    7. Subjects with a history or presence of gout or uric acid nephrolithiasis.

    8. Subjects with a serum creatinine >2 mg/dL (180 umol/L) at Screening.

    9. Subjects with a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 X Upper Limit of Normal (ULN) at Screening.

    10. Subject who has received any treatment listed in Table 2 (Prohibited medications for Entry into the Study) in the protocol more recently than the indicated washout period prior to surgery or must continue to receive treatment that is listed in Table 2. (Prohibited medications: 12 hour washout period prior to surgery for caffeine; 24 hr washout period prior to surgery for adenosine, aminophylline, nicotinic acid, pentoxifylline, theophylline, and cardioplegia solutions containing adenosine, dipyridamole, or lidoflazine; 2 day washout period prior to surgery for dipyridamole; 4 day washout period prior to surgery for allopurinol or febuxostat; 30 day washout period prior to Screening for investigational drugs)

    11. Administration of food and drinks containing caffeine, theobromines or methylxanthines (such as coffee, tea, colas, some 'energy' drinks or chocolate) is not allowed within 12 hours before surgery.

    12. Subjects with known allergy/sensitivity to acadesine or its/their excipients.

    13. Woman who is breast-feeding, pregnant or intends to become pregnant within 30 days of study drug administration.

    14. Subject who has used any investigational drugs within 30 days of Screening.

    15. Subject who is participating in any other interventional clinical study
    (noninterventional observational studies (eg, registry studies) are allowed).

    16. Subject who is part of the staff personnel directly involved with this study or who is a family member of the investigational study staff.

    17. Subject with an inability or unwillingness to abide by the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for the study is the first occurrence of any component of the composite of all-cause death, non-fatal stroke, or need for mechanical support for SLVD occurring during and following CABG surgery through POD 28.

    The efficacy endpoints are defined as:
    -All-cause Death.
    -Non-fatal Stroke: The diagnosis of stroke will be adjudicated by Clinical Events Committee(CEC), and criteria for the diagnosis are described in the CEC charter.
    -Need for mechanical support for severe left ventricular dysfunction (SLVD): new use during or after CABG surgery of any mechanical support including IABP, VAD, ECMO, etc, for ≥one (1) hour for treatment of low cardiac output. Indications for using mechanical support are determined by the attending physician based on his/her clinical judgment. Indications can include, but are not limited to cardiogenic shock, support for high-risk cardiac surgery, trouble of weaning from CPB, refractory left ventricular failure, refractory ventriculararrhythmias, and other indications that the investigators deem necessary for treatment of low cardiac output.

    Please refer to the protocol for other endpoints.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    Pharmacist at study site unblinded when study drug prepared within pharmacy
    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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    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 months24
    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 months24
    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 state750
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2400
    F.4.2.2In the whole clinical trial 7500
    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 Decision2009-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-10-04
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