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    Summary
    EudraCT Number:2007-000860-25
    Sponsor's Protocol Code Number:CSPP100E2337
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-09-18
    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 number2007-000860-25
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, parallel-group study to determine whether, in patients with type 2 diabetes at high risk for cardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality
    A.4.1Sponsor's protocol code numberCSPP100E2337
    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 SPP100
    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.3.11 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 SPP100
    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.3.11 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
    Diabetes type 2
    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 determine whether aliskiren, compared to placebo, when added to conventional treatment, delays the occurrence of cardiovascular and renal complications in patients with type 2 diabetes at high risk for cardiovascular and renal events.

    For details on definition of cardiovascular or renal complications, please refer to the protocol.
    E.2.2Secondary objectives of the trial
    • To determine whether aliskiren, compared to placebo, when added to
    conventional treatment delays the occurrence of cardiovascular complications. For details on definition of cardiovascular complications, please refer to the protocol.
    • To determine whether aliskiren, compared to placebo, when added to
    conventional treatment delays the occurrence of renal complications. For details on definition of renal complications, please refer to the protocol.

    Exploratory objectives:
    For full list, please refer to the protocol.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Exploratory pharmacogenetic and mRNA expression profiling sub-study for CSPP100E2337.
    A randomized, double-blind, placebo-controlled, parallelgroup study to determine whether, in patients with type 2 diabetes at high risk for cardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality.

    Objective: a) examining whether individual genetic variation in genes relating to drug metabolism, type 2 diabetes with renal and cardiovascular risk, and the drug target pathway confer differential response to aliskiren and b) examining the effect of aliskiren on gene expression in peripheral blood cells in type2 diabetic patients at risk for renal and cardiovascular disease

    date : 26-Mar-2007
    version of substudy: 1st version
    E.3Principal inclusion criteria
    For full list, please refer to the protocol

    1. Patients with type 2 diabetes according to WHO definition
    2. Male or female patients ≥ 35 years of age.
    3. Patients who provide written informed consent to participate in the study
    after the purpose and nature of the investigation have been clearly explained to
    them
    4. Patients with at least one of the following :
    • Persistent macroalbuminuria (UACR ≥ 200 mg/g [or 22.6 mg/mmol] in at least
    two out of three first morning void urine samples)
    • Persistent microalbuminuria (UACR ≥ 20 mg/g and < 200 mg/g [or UACR ≥
    2.26 mg/mmol and < 22.6 mg/mmol] in at least two of three morning void
    urines) and a mean eGFR < 60 mL/min/1.73m2 calculated by the abbreviated
    MDRD study equation (Levey, et al 2000) (mean of two consecutive
    measurements)
    • A history of cardiovascular disease and a mean eGFR < 60 mL/min/1.73m2
    History of cardiovascular disease is defined as at least one of the following:
    • Previous MI (previous hospitalization with a discharge diagnosis of MI)
    • Previous stroke (previous hospitalization with a discharge diagnosis of
    stroke. A previous transient ischemic attack -TIA- is not sufficient to fulfill this
    criterion)
    • HF (previous hospitalization with a discharge diagnosis of HF, with or without
    preserved ejection fraction)
    • Coronary artery disease (CAD) defined as follows:
    • History of percutaneous coronary intervention [PCI]
    • Coronary artery bypass graft [CABG]
    • Angiographically proven stenosis ≥ 50% in at least one major epicardial
    coronary artery
    5. Patient's concomitant treatment must include an ACEI or an ARB. Patient should
    be on conventional therapy according to national guidelines. Patients must not
    have had any adjustments to their concomitant antihypertensive therapy for at
    least four (4) weeks prior to randomization (Visit 3).
    E.4Principal exclusion criteria
    For full list, please refer to the protocol

    1. eGFR < 30 mL/min/1.73m2 as calculated by the abbreviated MDRD study
    equation (mean of two consecutive measurements).
    2. Serum potassium >5.0 mmol/L (at the visit directly preceding Visit 3). If the
    investigator has reason to believe the serum potassium result is invalid, one
    repeat test may be done.
    3. History of any cardiovascular event (stroke, transient ischemic cerebral attack,
    MI, unstable angina, CABG, percutaneous coronary intervention, hospitalization
    due to HF) during the 3 months prior to Visit 1.
    • If a patient experiences such an event between Visit 1 and randomization at
    Visit 3, he/she should be withdrawn from the screening phase. If suitable, the
    patient can be re-screened at a later stage (see Section 5.2).
    4. Hypertension (at Visit 3): any patient with a mean sitting systolic blood pressure
    (msSBP) ≥ 135 mmHg or msDBP ≥ 85 mmHg should be excluded unless treated
    with at least 3 anti-hypertensive medications; even if treated with 3 or more
    anti-hypertensive agents, a patient with msSBP ≥ 170 mmHg or msDBP ≥ 110
    mmHg must be excluded.
    5. Congestive heart failure NYHA class III or IV.
    6. Concomitant treatment with two (2) or more renin-angiotensin-aldosterone
    system blocking agents apart from the study drug, e.g. ACEI, ARB or
    aldosterone-antagonist or any renin inhibitor.
    7. Unstable serum creatinine: defined as ≥ 20% difference between 2 consecutive
    serum creatinine measurements before Visit 3. A maximum of 4 measurements
    will be allowed. If the difference between the first 2 measurements is ≥ 20% of
    the higher value, a third measurement should be performed at the next visit. If
    the difference between the last 2 measurements is ≥ 20% of the higher value,
    at fourth measurement should be performed at the next visit. If the difference
    between the last two measurements performed is ≥ 20%, the patient is
    excluded.
    8. Second or third degree heart block without a pacemaker.
    9. Concurrent potentially life threatening arrhythmia or other uncontrolled
    arrhythmia.
    10. Clinically significant valvular heart disease.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the time to the first event of the primary composite endpoint consisting of CV death, resuscitated sudden death, non-fatal MI, non-fatal stroke, unplanned hospitalization for HF, onset of ESRD, renal death, and doubling of serum creatinine concentration from baseline, sustained for at least for one month and above the upper limit of normal. It will be calculated in days for each patient as the difference between the date of the first event or censoring date if no event occurs and the date of randomization visit (day 1) plus one. The primary composite endpoint will be derived based on the adjudicated events.
    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 Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA483
    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
    Study duration is expected to be 4 years. However, the study will continue until 1620 patients have reached primary endpoint.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4400
    F.4.2.2In the whole clinical trial 8600
    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 Decision2007-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-12-20
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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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