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    Summary
    EudraCT Number:2013-002312-27
    Sponsor's Protocol Code Number:13-031
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-13
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-002312-27
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess Clinical Efficacy and Safety of Danegaptide in Patients with ST-Elevation Myocardial Infarction undergoing Primary Percutaneous Coronary Intervention
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial Investigating the Effectiveness and Safety of a New Drug, Danegaptide, in Reducing Cardiac Muscle Damage after Treating an Acute Blood Cloth in the Heart with Balloon Dilatation.
    A.4.1Sponsor's protocol code number13-031
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorZealand Pharma
    B.1.3.4CountryDenmark
    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 supportZealand Pharma a/s
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZealand Pharma a/s
    B.5.2Functional name of contact pointUlrik Mouritzen
    B.5.3 Address:
    B.5.3.1Street AddressSmedeland 36
    B.5.3.2Town/ cityGlostrup
    B.5.3.3Post code2600
    B.5.3.4CountryDenmark
    B.5.4Telephone number4550603726
    B.5.6E-mailumo@zealandpharma.com
    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 namedanegaptide
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDanegaptide
    D.3.9.1CAS number 943134-39-2
    D.3.9.2Current sponsor codeZP1609
    D.3.9.3Other descriptive name1-(2-aminoacetyl)-4R-benzamidopyrrolidine-2S-carboxylic acid hydrochloride monohydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboSolution for injection/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
    The treatment of acute myocardial infarction, AMI is aimed at enabling the return of blood flow to the ischemic myocardium, thereby limiting the size of the infarct. However the reperfusion by itself causes additional damage to the myocardium. Reducing the size of the myocardial infarct can minimize the risk of heart failure and death.
    E.1.1.1Medical condition in easily understood language
    This protocol target Patients having an acute myocardial infarction with ST-elevation on ECG. Standard treatment pr. guideline is balloon angioplasty, PCI, to reperfuse the myocardium.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10063837
    E.1.2Term Reperfusion injury
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10064345
    E.1.2Term ST segment elevation myocardial infarction
    E.1.2System Organ Class 100000004849
    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 the study is to compare the efficacy of two dose levels of Danegaptide to placebo when added to the standard treatment of STEMI in patients with single vessel disease having TIMI flow 0 or 1 prior to PCI conducted within 6 hours of symptoms debut.
    E.2.2Secondary objectives of the trial
    - To explore the efficacy of two dose levels of Danegaptide compared to placebo when added to the standard treatment of STEMI patients
    - To explore additional functional, pharmacodynamic and clinical effects of Danegaptide when added to the standard treatment of STEMI patients.
    - To describe pharmacokinetic parameters (PK) of Danegaptide
    - To describe the safety of two dose levels of Danegaptide relative to placebo when added to the standard treatment of STEMI patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be entered into this trial only if they meet all of the following criteria:
    1. Men or women of minimum 18 years of age
    2. STEMI as characterized by one of following:
    a. minimum 2 mV ST-segment elevation in 2 or more leads (V1 through V4)
    b. presumed new left bundle branch block with minimum of 1 mV concordant ST segment elevation
    c. minimum 1 mV ST-segment elevation in 2 or more limb leads (II, III and aVF, I, aVL)
    d. minimum 1mV ST segment elevation in 2 or more leads (V4-V6)
    3. Clinical ischemic symptoms consistent with acute myocardial infarction (MI) for a maximum of 12 hours prior to percutaneous coronary intervention (PCI)
    4. Women of childbearing potential must during the past 3 months have used an acceptable method of contraception to avoid pregnancy (hormonal contraceptives, intrauterine device or double barrier method (male condom plus diaphragm) and agree to use it throughout the study or practice sexual abstinence.
    Note: A woman of childbearing potential is defined as any female:
    a. who is not postmenopausal (defined as women over the age of 50 who have been amenorrheic for at least 12 consecutive months)
    b. who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy)
    5. Willingness and ability to provide written informed consent
    E.4Principal exclusion criteria
    1. Current participation or participation within the past 30 days in any other investigational study
    2. Women who are pregnant or breastfeeding or who plan on becoming pregnant during the study
    3. Known prior MI in same area as present STEMI, known conclusive hypertrophic or dilated cardiomyopathy, or prior hospital admission for heart failure
    4. More than 12 hours between the onset of symptoms of acute MI and anticipated revascularization
    5. Anticipated requirement, as assessed prior to randomization, for a staged treatment of coronary artery disease or other interventional or surgical procedures to treat heart disease (e.g., valve replacement, PCI, or coronary artery bypass graft) planned or scheduled to take place within 6 months after the investigational agent infusion
    6. Receipt of any thrombolytic agent since onset of acute MI symptoms
    7. Cardiogenic shock or hemodynamic instability within 24 hours prior to randomization, except brief VF that has been successfully cardioverted
    8. Prior PCI or CABG of same coronary artery as present STEMI
    9. Known contraindication to cardiac magnetic resonance imaging (MRI) such as significant claustrophobia, severe allergy to gadolinium chelate contrast, severe renal insufficiency (defined as estimated glomerular filtration rate [eGFR] less than 30 mL/min/1.73 m2), presence of MRI contraindicated implanted devices (e.g., pacemaker, implanted cardiac defibrillator, cardiac resynchronization therapy device, cochlear implant), imbedded metal objects (e.g. shrapnel), or any other contraindication for cardiac MRI
    10. Known active malignancy with an expected life-expectancy of less than 2 years
    11. Previous enrolment in this study
    12. Any concurrent condition, which, in the opinion of the investigator, would make the patient unsuitable for participation in the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is Myocardial Salvage Index (MSI) measured at Day 90.
    MSI is assessed by cMRI and is calculated as the relative change, from baseline to day 90, in myocardial volume at risk

    MSI is defined as:
    MSI = (AAR (g) – Final Infarct Size (g))/AAR (g)

    where AAR (Area at Risk) is assessed as oedema visualized and measured by cMRI using T2 weighted short tau inversion-recovery sequence at Day 2,
    and Final Infarct Size is assessed as hyper-enhanced myocardial tissue visualized and measured by cMRI using gadolinium-enhanced images at Day 90.


    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 2 (48-72 hours) Magnetic Resonnance Imaging for AAR assessment and day 90 MRI for Final Infarct Size.
    E.5.2Secondary end point(s)
    Secondary MRI parameters:
    - Relative infarct size ((%) [infarct size/left ventricle (LV) size (g/g)] × 100), as assessed by LGE cMRI, at Day 90
    - Relative infarct size (%) at baseline and change in infarct size from baseline to Day 90
    - Absolute infarct size (g) and change in absolute infarct size at baseline and Day 90
    - Left ventricular ejection fraction (LVEF) at baseline and Day 90 and change in LVEF from baseline to Day 90
    - Change in LV wall thickness of all segments at end diastole and end systole from baseline to Day 90
    - Change in left ventricular end-systolic volume (LV-ESV) as measured by cMRI from baseline to Day 90
    - Change in left ventricular end-diastolic volume (LV-EDV) as measured by cMRI from baseline to Day 90
    - Relative volume with microvascular obstruction (MVO) as assessed by cMRI at Day 2
    - Relative volume with infarct haemorrhage by cMRI at Day 2

    Secondary Efficacy Endpoints (Non-imaging):
    - 90-day clinical outcome/MACE [cardiac death, new or worsening heart failure (during the initial hospitalization) and re-hospitalization due to heart failure]
    - Occurrence of arrhythmias during hospitalization and hospitalization for arrhythmias during the follow-up period
    - Degree of ST-resolution and fraction of patients with ≥ 70% ST-resolution measured 60 minutes post-PCI procedure
    - Infarct size, as assessed by area under the plasma concentration-time curve (AUC 0-48 hours) for creatine kinase-MB and TnT
    - TIMI-flow as assessed immediately after the PCI procedure
    - Adverse events incl. all cause mortality, stroke, arrythmias and ICD implantation
    -Quality of Life assessment according to SF-36 and EQ-5D

    Secondary PK Endpoints:
    - Plasma concentration of Danegaptide at the end of the PCI procedure
    - Post infusion plasma concentration of Danegaptide (7-12 hours)
    - Estimated half-life and clearance of Danegaptide
    - Estimated volume of distribution at steady state (Vss) based on the plasma concentration of Danegaptide measured at the end of infusion


    Safety Endpoints:
    - Incidence of treatment-emergent adverse events and serious adverse events relative to placebo
    - Changes in physical examination and vital signs relative to placebo
    - Changes in laboratory parameters relative to placebo
    - Changes in ECG parameters relative to placebo

    Exploratory Pharmacodynamic Endpoint:
    - Biochemical changes associated with, but not limited to, AMI perfusion injury or PD effects of danegaptide
    E.5.2.1Timepoint(s) of evaluation of this end point
    End point evaluation at the end of trial if not specified above in Section E.5.2.
    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 Yes
    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) 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    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 months9
    E.8.9.1In the Member State concerned days
    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.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 Yes
    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.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 are no post trial treatment that differs from standard follow up after an acute ST-elevation MI treated with primary Percutaneous Coronary Intervention (PCI).

    A min. of 600 patients above age 18 to be included. Maximum of 750 patients.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-04
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