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    Summary
    EudraCT Number:2009-017028-22
    Sponsor's Protocol Code Number:CSPP100A2365
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-03-14
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2009-017028-22
    A.3Full title of the trial
    A multicenter, randomized, double-blind, 8 week study to evaluate the dose response, efficacy and safety of
    aliskiren in pediatric hypertensive patients 6-17 years of age.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study examining the short term safety and efficacy of the drug aliskiren in the treatment of high blood pressure in children 6-17 years old
    A.4.1Sponsor's protocol code numberCSPP100A2365
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/237/2011
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma Services AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1, Novartis Campus
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4161 3241111
    B.5.5Fax number+41613248001
    B.5.6E-mailclinicaltrial.enquiries@novartis.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 nameAliskiren
    D.3.2Product code SPP100
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Yes
    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.3.9.1CAS number 173334-57-1
    D.3.9.2Current sponsor codeSPP100
    D.3.9.4EV Substance CodeSUB21380
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number600
    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 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
    Hypertension
    E.1.1.1Medical condition in easily understood language
    Hypertension (high blood pressure)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10020772
    E.1.2Term Hypertension
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - In Phase 1, to evaluate the dose response of aliskiren in msSBP change at end of Phase 1 from the baseline, as measured by office blood pressure reading, in
    children 6 to 17 years old with hypertension.
    - In Phase 2 (placebo controlled phase), to evaluate pooled treatment effect of aliskiren in msSBP change at end of Phase 2 from the end of Phase 1, compared to placebo pooled from corresponding arms, as measured by office blood pressure reading, in children 6 to 17 years old with hypertension.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of short-term (8 weeks) administration of aliskiren in children aged 6 to 17 years with hypertension.
    - In Phase 1, to evaluate the dose response of aliskiren in msDBP and MAP change at end of Phase 1 from the baseline, as measured by office blood pressure reading, in
    children 6 to 17 years old with hypertension.
    - In Phase 2 (placebo controlled phase), to evaluate pooled treatment effect of aliskiren in msDBP and MAP change at end of Phase 2 from the end of Phase 1, compared to placebo pooled from corresponding arms, as measured by office blood pressure reading, in children 6 to 17 years old with hypertension.
    - To explore the effect of aliskiren at low, mid and high doses on the 24 hour ambulatory blood pressure monitoring (ABPM) profiles.
    - To explore the relationship between change in plasma renin activity (PRA) and the dose of aliskiren, at the end of Phase 1, in children aged 6 to 17 years with hypertension
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female, ages 6 years to 17 years 6 months at randomization, with a documented diagnosis of
    hypertension as defined in the NHLBI 4th Report, 2004
    • Must be ≥ 20 kg and ≤ 150 kg at randomization (Visit 2)
    • Must be able to safely wash out prior antihypertensive therapy for a minimum of 7 days if already receiving treatment
    • Must be able to swallow minitablets (2mm in diameter) administered in soft food
    • msSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2
    (randomization) measurement as defined by the NHLBI 4th Report, 2004
    • Patients who are eligible and able to participate in the study and whose parent(s)/guardian(s) consent in writing (written informed consent) to their doing so after the purpose and nature of the investigation has been clearly explained to them. (An assent may be required for some patients depending upon their age and local requirements regarding assents.)
    E.4Principal exclusion criteria
    • Renal artery stenosis
    • History of angioedema
    • Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or
    obstructive valvular disease
    • msSBP ≥ 25% above the 95th percentile
    • Second or third degree heart block without a pacemaker
    • Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening, or any symptomatic arrhythmia during the 12 months prior to Visit 1
    • Previous solid organ transplantation
    • Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
    • Human immunodeficiency virus (HIV) by history and/or the patient is concomitantly receiving anti-retroviral therapy for the treatment of HIV
    • Any clinically significant unstable medical condition or chronic disease that would put the patient at risk of experiencing an adverse event associated with the expected pharmacodynamic effects of the study medication
    • Any surgical or medical condition or concomitant medication which might significantly alter the absorption, distribution, metabolism, or excretion of study medication
    • Current treatment with atorvastatin, cholestyramine or colestipol resins, monoamine oxidase (MAO) inhibitors, ketoconazole, itraconazole, or antiarrhythmic medications (other than digoxin)
    • History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
    • History or evidence of drug or alcohol abuse within the last 12 months
    • Females of child-bearing potential, defined as all females aged 8 years and above,
    physiologically capable of becoming pregnant, including women whose lifestyle or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they are willing to use an acceptable, hormonal or non-hormonal form of birth control, including for non-hormonal forms of birth control, double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap), or abstinence
    • Pregnant or nursing (lactating) women
    • History of hypersensitivity to study medication or to any drug of similar chemical class
    • Participation in any investigational drug study within 30 days
    • Any condition that in the opinion of the investigator would confound the evaluation and interpretation of efficacy and/or safety data
    E.5 End points
    E.5.1Primary end point(s)
    To assess dose response and short term efficacy of aliskiren
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, end of weeks 4 and 8
    E.5.2Secondary end point(s)
    To assess short term safety of aliskiren
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, end of weeks 4 and 8
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) 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.8.2.4Number of treatment arms in the trial3
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Turkey
    United States
    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.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 138
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 137
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 275
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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