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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2006-006034-18
    Sponsor's Protocol Code Number:06004
    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:2007-01-29
    Trial 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 number2006-006034-18
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER
    STUDY TO EVALUATE THE CARDIOPROTECTIVE EFFECTS OF MC-1 IN PATIENTS
    UNDERGOING HIGH-RISK CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY
    A.3.2Name or abbreviated title of the trial where available
    MEND-CABG II
    A.4.1Sponsor's protocol code number06004
    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 SponsorMedicure International Inc.
    B.1.3.4CountryCanada
    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 nameMC-1
    D.3.4Pharmaceutical form 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 INNPyridoxal 5'-Phosphate (P5P) monohydrate
    D.3.9.1CAS number 41468-25-1
    D.3.9.2Current sponsor codeMC-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number268,22
    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 nameMC-1
    D.3.4Pharmaceutical form Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPyridoxal 5'-Phosphate (P5P)
    D.3.9.1CAS number 41468-25-1
    D.3.9.2Current sponsor codeMC-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboCoated 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 placeboPowder for injection*
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    For treatment to reduce cardiovascular events associated with ischemic
    damage and/or ischemia-reperfusion injury in patients undergoing CABG surgery.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10051624
    E.1.2Term Myocardial reperfusion injury
    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 effect of MC-1 on the combined incidence of cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days following CABG surgery compared with placebo.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to determine:

    • Length of hospital stay for index hospitalization
    • Length of stay in ICU/coronary care unit (CCU) for index hospitalization
    • Incidence of cardiovascular death up to and including post operative day 90
    (POD 90)

    Additional pre-specified secondary endpoints will include:
    • Incidence of cardiovascular death or nonfatal MI up to and including POD 90;
    • Incidence of cardiovascular death up to and including POD 4 and POD 30;
    • Incidence of nonfatal MI up to and including POD 4, POD 30, and POD 90;
    • Incidence of nonfatal cerebral infarction up to and including POD 4, POD 30, and
    POD 90;
    • Incidence of all-cause mortality up to and including POD 4, POD 30, and POD 90;
    • MMSE score at POD 30 and POD 90 (MMSE score among patients whose MMSE at screening was ≤27);
    • CK-MB AUC (0-24 hours) (CK-MB AUC (0-24 hours) among patients who had a nonfatal MI)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Provide informed consent
    • Patients who are ≥18 years of age
    • Male patients, or female patients who are not of childbearing potential or female patients who have had a negative pregnancy test and are practicing adequate contraception
    • Patients must be scheduled to undergo CABG surgery with planned cardiopulmonary bypass, during routine scheduling times
    • Patients must be considered at “high-risk” for subsequent myocardial complications
    defined as meeting TWO OR MORE of the following criteria :
    o Age ≥ 65 years
    o Current or recent smoker (within the last 6 months)
    o History of diabetes mellitus requiring treatment other than diet
    o Evidence of left ventricular dysfunction or congestive heart failure
    o History of a previous non-disabling stroke, transient ischemic attack, or
    carotid endarterectomy
    o Urgent CABG intervention defined as the need to stay in the hospital
    o History of MI that occurred more than 48 hours but less than 6 weeks prior
    to CABG surgery
    o Prior peripheral artery surgery or angioplasty
    o Moderate renal dysfunction defined as creatinine clearance > 30 ml/min, but
    < 60 ml/min
    o Presence of at least one asymptomatic carotid artery stenosis (>50%) either
    in one or two carotid arteries
    E.4Principal exclusion criteria
    • Planned associated valve surgery or concurrent carotid endarterectomy
    • Planned aortic dissection repair or aortic root reconstruction
    • Screening visit occurring less than 4 hours before scheduled CABG surgery
    • MMSE Score less than 24 at the screening visit
    • Current cardiogenic shock, acute left ventricular rupture, ventricular septal rupture,
    or papillary muscle rupture
    • Uncontrolled diabetes defined as fasting serum blood glucose value equal to or
    greater than 24 mmol/L (432 mg/dl) at the time of screening (if fasting serum blood
    glucose not obtained at screening, values obtained within 30 days prior to screening
    visit may be used)
    • MI occurring <48 hours prior to planned CABG surgery
    • Severe renal dysfunction defined as an estimated creatinine clearance value <30
    ml/min or nephrotic syndrome at screening (or measured creatinine clearance value
    obtained within 30 days prior to screening visit)
    • History of liver cirrhosis, chronic active hepatitis (known positive serum test within
    6 months of enrolment) or severe liver dysfunction, or known liver transaminase ≥3 times ULN
    • History of malignancy during the last 5 years except for basal cell carcinoma
    • Planned surgery for atrial fibrillation
    • Planned associated transmyocardial revascularization
    • Planned associated ventricular remodeling
    • Pregnancy, as determined by a pregnancy test
    • Any medical or psychiatric condition which in the opinion of the investigator makes
    the patient an unsuitable candidate for the study
    • Significant, ongoing alcohol or drug abuse
    • Participation in any other investigational drug or device study within 30 days of
    randomization
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the incidence of cardiovascular death or nonfatal MI up to and including post-operative day (POD) 30.
    Nonfatal MI will be defined as a peak creatine kinase myocardial band (CK-MB) level
    ≥100 ng/ml up to and including POD 4, or a new 30 ms q-wave in 2 contiguous leads along with CK-MB of ≥70 ng/ml on days up to and including POD 4, or a new peak CK-MB of ≥25 ng/ml or above occurring after POD 4, or a new 30 ms q-wave in 2 contiguous leads that was not present at POD 4, or a q-wave or non-q-wave MI as identified by the investigator and confirmed by the Clinical Endpoint Committee (CEC).
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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) 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 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
    see section 6.3 and 6.4 of the protocol
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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 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 state600
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 3000
    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)
    There will be no tretatment or additional care after the subject has ended his/her participation (see also separate statment)
    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 Decision2007-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-03-05
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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