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    Summary
    EudraCT Number:2009-016077-14
    Sponsor's Protocol Code Number:RALF1
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-06-10
    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 ConcernedFinland - Fimea
    A.2EudraCT number2009-016077-14
    A.3Full title of the trial
    Role of ALiskiren, a direct renin inhibitor, in preventing atrial Fibrillation in patients with a pacemaker; RALF
    Eteisvärinäkuorman määritys sydämentahdistimella aliskireenihoidossa
    A.3.2Name or abbreviated title of the trial where available
    RALF
    A.4.1Sponsor's protocol code numberRALF1
    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 SponsorMika Lehto
    B.1.3.4CountryFinland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name Rasilez
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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.3.4Pharmaceutical form 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.3.9.1CAS number 0
    D.3.9.3Other descriptive nameALISKIREN HEMIFUMARATE
    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 Yes
    D.3.11.13.1Other medicinal product typeCardiovascular product of chemical origin for human use
    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 placeboTablet
    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
    Patients who have a pacemaker due to sinus node disease and paroxysmal atrial fibrillation.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10067824
    E.1.2Term Prophylaxis against atrial fibrillation
    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 endpoint of this study is the AF burden measured as mean time (percent-age) of AF seen by the pacemaker during the each 6 months study period with an al-located treatment. AF periods lasting more than 48 hours will not be considered as paroxysmal episodes, and therefore will not be included to the AF burden.
    E.2.2Secondary objectives of the trial
    The secondary endpoints for this study are the 1) number of AF episodes 2) number of persistent AF episodes lasting more than 48 hours 3) total AF burden including epi-sodes lasting more than 48 hours 4) number of electrical or medical cardioversions 5) time to first persistent AF episode lasting more than 48 hours during each period 6) the number of patients who will have chronic AF 7) number of health-care provider contacts due AF and 8) the length of the paced P-wave measured by high resolution ECG (SAECG) after each period. The pacing site at right atrium will also be taken into consideration in the P-wave analysis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The study population is patients from HUCH pacemaker policlinics with an earlier im-planted pacemaker because of sinus node disease and paroxysmal AF. It is antici-pated to enrol 70 patients aged 18-80 years to this study during 9 months. The follow-ing inclusion and exclusion criteria will be used for this study.

    Inclusion criteria:
    - age between 18 and 80 years
    - sinus node disease and paroxysmal AF
    - provided signed informed consent according to the Declaration of Helsinki for study participation
    - a previously implanted St. Jude Medical Identity / Victory / Zephyr / Accent / Anthem DDDR DDDR pacemaker with ability to record high atrial rates
    E.4Principal exclusion criteria
    Exclusion criteria:
    - contraindication for the use of aliskiren
    - severe impairment of renal function (serum creatinine > 160 µmol/L) or patient with solitary kidney or renal transplant or renal artery stenosis
    - significant known aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy
    - hypersensitivity to aliskiren or to any of the excipients
    - concomitant treatment with cyclosporine
    - patients with uncontrolled hypertension requiring treatment for hypertension
    - systolic blood pressure measured in two separate occasions ≥ 160 mmHg
    - diastolic blood pressure in two separate occasions ≥ 100 mmHg
    - absolute indication for the use of an RAAS blocker
    - chronic, persisting AF (persisting AF at screening with ≥ 4 cardioversions performed beforehand)
    - sitting systolic arterial blood pressure of less than 100 mm Hg at the time of randomisa-tion
    - need for ventricular pacing more than 30% at the enrolment
    - pregnancy and/or lactation
    - women of childbearing potential (only postmenopausal women or women after tubal ligation will be allowed)
    - other serious disease expected to cause substantial deterioration of patient’s health during the next two years
    - past or present alcohol or drug abuse
    - participation in other clinical trials during the last three months
    - suspicion of poor study compliance
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the AF burden measured as mean time (percent-age) of AF seen by the pacemaker during the each 6 months study period with an al-located treatment. AF periods lasting more than 48 hours will not be considered as paroxysmal episodes, and therefore will not be included to the AF burden.
    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 Yes
    E.6.4Safety No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    The AF burden is measured as mean time (percentage) of AF seen by the pacemaker during the each 6 months study period with an allocated treatment. When the data after the last visit after the last study period of the last patient in the the study is collected the trial is definied to be ended. This also is applied if this end occurs prematurely if the patient is unable to participate, expresses a desire to withdraw, or is unwilling to continue participation in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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 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.1.3Elderly (>=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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    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)
    After 6 months of screening period the patients are randomized to initial therapy of aliskiren or placebo for 6 months. For the third study period the patients are crossed-over to the other therapy arm also for 6 months. The study lasts altogether for 18 months, and af-ter each 6 months period the pacemakers’ data of total AF burden will be evaluated.
    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 Decision2010-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-01-31
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