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    Summary
    EudraCT Number:2006-001704-37
    Sponsor's Protocol Code Number:CSPP100A2340
    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:2006-10-24
    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 number2006-001704-37
    A.3Full title of the trial
    A 36 week, multicenter, randomized, double-blind, placebo- controlled, parallel-group, pilot study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-AMI patients when added to optimized standard therapy
    A.4.1Sponsor's protocol code numberCSPP100A2340
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 nameAliskiren
    D.3.2Product code SPP100A
    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 INNAliskiren
    D.3.9.2Current sponsor codeSPP100
    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 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 nameAliskiren
    D.3.2Product code SPP100A
    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 INNAliskiren
    D.3.9.2Current sponsor codeSPP100
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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 placeboFilm-coated tablet
    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
    Myocardial infarction
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that aliskiren 300 mg, in addition to standard therapy, has superior efficacy compared to placebo in reducing the primary index of adverse cardiac remodeling (defined as the change in LVESV from baseline to end of study) in patients after high risk acute myocardial infarction.
    E.2.2Secondary objectives of the trial
    For full list, refer to protocol

    To evaluate the effect of aliskiren compared to placebo on:
    • a composite outcome of CV death, hospitalization for heart failure, or a reduction
    in ejection fraction greater than 6 units (absolute percentage points)
    • a composite outcome of time to CV death, hospitalization for heart failure,
    recurrent myocardial infarction, stroke or resuscitated sudden death
    • change in left ventricular ejection fraction (LVEF) between baseline and end of
    study
    Exploratory Objectives:
    To evaluate the effect of aliskiren compared to placebo on:
    • renal function as measured by change in estimated glomerular filtration rate
    (eGFR), cystatin C, and urinary albumin creatinine ration (uacr) from baseline to
    end of study (in a subset of patients)
    • other biological markers relevant to the pathophysiology of remodeling and other
    outcomes after myocardial infarction (in a subset of patients)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients 18 years and older.
    2. Patients within 7-42 days of an acute myocardial infarction associated with left
    ventricular systolic dysfunction prior to Visit 1 (see below). A qualifying myocardial
    infarction will require each of the following:
    • Typical clinical presentation consistent with myocardial infarction (i.e., chest pain,
    shortness of breath)
    • Elevation of cardiac markers (any of the following will fulfill the requirement for
    an increase in cardiac markers):
    • Both total CK and CK-MB are above the upper limit of normal (ULN) and either
    total CK or CK-MB are at least twice the upper limit of normal (2xULN)
    • CK-MB is elevated to at least twice the upper limit of normal (2xULN) when
    total CK is not available, and is confirmed by an accompanying Troponin T or I
    level at least three times the upper limit of normal (3xULN)
    • Total CK is elevated to at least twice the upper limit of normal (2xULN) when
    CK-MB is not available, or to above the ULN if confirmed by an accompanying
    Troponin T or I level at least three times the upper limit of normal (3xULN)
    • Troponin T or I level is at least five times the upper limit of normal (5xULN) and
    neither total CK nor CK-MB are available.
    • Typical ECG changes, including evolving ST-segment or T-wave changes in two
    or more contiguous ECG leads, the development of new pathological Q/QS
    waves in two or more contiguous ECG leads, or the development of new left
    bundle branch block.
    3. Documented left ventricular systolic dysfunction associated with the qualifying
    acute myocardial infarction obtained as a clinical evaluation (study) prior to Visit 1. Systolic dysfunction will be defined by at least one of the following criteria:
    If the clinical imaging was obtained < 5 days post-MI but prior to Visit 1, the left ventricular ejection fraction (LVEF) must be as follows:
    • Echocardiography: (LVEF) ≤ 35%
    • Radionuclide ventriculography: LVEF ≤ 35%
    • Ventricular contrast angiography: LVEF ≤ 35%.
    or
    If the clinical imaging was obtained ≥ 5 days post-MI but prior to Visit 1, the LVEF must be as follows:
    • Echocardiography: (LVEF) ≤ 40%
    • Radionuclide ventriculography: LVEF ≤ 40%
    • Ventricular contrast angiography: LVEF ≤35%.
    4. Patients should be on stable doses of the following standard of care post-MI concomitant medications for at
    least 2 weeks prior to Visit 1 unless contraindicated due to intolerance:
    • A Beta-blocker
    • An Anti-platelet agent
    • A Statin
    5. Patients must be on a stable evidence-based dose /see Appendix 3) of an Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) but not both, for at least 2 weeks prior to Visit 1, unless contraindicated due to intolerance. For patients not on an envidence-based dose of an ACEI or an ARB, the reason (e.g., patient intolerant of these medications) must be documented.
    6. Patients who are eligible, able to participate in the study, and who consent to do
    so after the purpose and nature of the investigation has been clearly explained to
    them (written informed consent).
    7. Qualifying Echocardiogram:
    • Patients who fulfill the screening inclusion and exclusion criteria will have a
    qualifying echocardiogram performed and transmitted to the Echo Core
    Laboratory. To be eligible for randomization, patients must fulfill the following
    criteria by the core laboratory:
    • Acceptable image quality
    • Confirmed LVEF = 45%
    • Qualifying Myocardial Infarct Percentage = 20% (akinetic or dyskinetic segment
    length as percent of total cavity perimeter).
    E.4Principal exclusion criteria
    For full list, please see protocol.

    1. Patients requiring both ACEI and ARB combination therapy at V1 or any time
    during the study.
    2. Hypertrophic cardiomyopathies due to etiologies other than hypertension (i.e.,
    idiopathic or valvular).
    3. Severe refractory hypertension defined as MSSBP = 180 mmHg and/or MSDBP =
    110 mmHg) at Visit 2.
    4. Hemodynamically significant stenotic or obstructive valvular, subvalvular or
    supravalvular lesions.
    5. Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or
    infective cardiomyopathy (e.g., Chagas’ disease).
    6. Cardiogenic shock or systolic BP < 100 mmHg or diastolic BP < 60 mmHg within the 24 hours prior to Visit 1 or 2.
    7. Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2 using the MDRD
    formula at Visit 1.
    8. Stroke or transient ischemic event (TIA) within 6 months of Study Visit 1.
    9. Serum potassium = 5.1 mEq/L, or dehydration at Study Visit 1.
    10. Significant valvular cardiovascular disease expected to lead to cardiac surgery
    during the course of the study.
    Comlpete list of exclusion criteria can be found in the protocole
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the change in left ventricular end systolic volume (LVESV) as assessed by echocardiography, from baseline to end of study.
    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 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) Information not present in EudraCT
    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 EEA105
    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 years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days5
    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 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 670
    F.4.2.2In the whole clinical trial 800
    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 Decision2006-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-24
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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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