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    Summary
    EudraCT Number:2008-006447-40
    Sponsor's Protocol Code Number:CSPP100A2366
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2008-006447-40
    A.3Full title of the trial
    A 104 week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy of aliskiren on the progression of atherosclerosis in patients with coronary artery disease when added to optimal background therapy
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberCSPP100A2366
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 FARMA
    B.1.3.4CountryItaly
    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 Yes
    D.2.1.1.1Trade name Rasilez
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Progression of atherosclerosis in patients with coronary artery disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10011093
    E.1.2Term Coronary atherosclerosis
    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 this study is: To evaluate the effect of aliskiren 300 mg, in addition to optimized background therapy, compared to placebo on progression of coronary atherosclerosis (defined as change from baseline in percent atheroma volume) as assessed by IVUS in patients with CAD and blood pressure in the pre-hypertensive (high normal) range with or without treatment for hypertension.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy profile of aliskiren 300 mg, in addition to optimized background therapy, compared to placebo on the change in normalized total atheroma volume as assessed by IVUS. To evaluate the efficacy profile of aliskiren 300 mg, in addition to optimized background therapy, compared to placebo, by comparing the proportion of patients who demonstrate evidence of atheroma regression (defined as any reduction in percent atheroma volume from baseline) as assessed by IVUS. To evaluate the overall safety and tolerability of aliskiren 300 mg compared to placebo in patients with CAD and blood pressure in the pre-hypertensive (high normal) range with or without treatment for hypertension following 104 weeks of treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must give written informed consent before any study related assessments are performed. 2. Male and female patients &amp;#8805; 35 years of age who are scheduled for a coronary catheterization procedure for a clinically indicated reason at Visit 1. 3. Patients with or without current treatment for hypertension must have a msSBP &amp;#8805; 125 and &amp;#8804; 139 mmHg and an msDBP < 90 mmHg at Visit 2. For those patients receiving treatment for hypertension, every effort should be made by the Investigator to have the patient on a stable dose (defined as dose unchanged for &amp;#8805; 1 week) of medication prior to Visit 2. 4. Patients must have at least two of the following risk factors present at Visit 1: History of prior myocardial infarction (MI), acute coronary syndrome (ACS) or previous coronary or peripheral revascularization. No prior treatment with a statin medication. If the patient has been previously treated at any time with a statin medication, it must be for a period of &amp;#8804; 3 months in the 12 months prior to Visit 1. HDL < 40 mg/dL (1.0 mmol/L) for men or < 50 mg/dL (1.3 mmol/L) for women OR triglycerides > 150 mg/dL (1.7 mmol/L) within 3 months of Visit 1 or at Visit 1. Microalbuminuria [defined as UACR &amp;#8805; 30 mg/g and < 300 mg/g (&amp;#8805; 3.4 mg/mmol and < 33.9 mg/mmol)] OR macroalbuminuria [defined as UACR &amp;#8805; 300 mg/g and < 3000 mg/g (&amp;#8805; 33.9 mg/mmol and < 339.3 mg/mmol)] within 3 months of Visit 1 or at Visit 1. Age > 55 years. Diagnosis of diabetes mellitus based on medical history, concomitant diabetic medications being taken at study entry OR a fasting plasma glucose (FPG) > 126 mg/dL (7.0 mmol/l ) or non fasting plasma glucose > 200 mg/dL (11.1 mmol/L) or HbA1c > 6.0 % at Visit 1. Current smoking within 4 weeks of Visit 1 or at Visit 1. History of LVH documented by ECG, echocardiogram or MRI performed &amp;#8804; 6 months prior to Visit 1. 5. Patients must meet all of the following criteria at the qualifying coronary catheterization procedure: Entire Coronary Circulation: Angiographic evidence of coronary heart disease as defined by at least one lesion in any of the three major native coronary arteries that has > 20% reduction in lumen diameter by angiographic visual estimation or prior history of PTCA. This vessel need not be the target coronary artery for IVUS (defined below). Any vessel with previous PTCA may not be used as the target coronary artery. Left Main Coronary Artery: Must not have a > 50% reduction in lumen diameter by visual angiographic estimation. PLS SEE PROTOCOL
    E.4Principal exclusion criteria
    1. Baseline IVUS study determined to be of unacceptable quality by the IVUS Core laboratory in accordance with the lab manual guidelines for acquisition and analysis of IVUS imaging prior to Visit 2. 2. Patients requiring continued treatment with any 2 of the following classes of medications at Visit 1 or Visit 2: ACEIs, ARBs, aldosterone receptor blockers or a direct renin inhibitor. 3. Patients with clinically significant heart disease, which in the opinion of the Investigator is likely to require coronary bypass surgery, PCI in the target vessel, surgical repair, ventricular assist device placement, cardiac transplantation, or require intra-aortic balloon pump support during the duration of the study. 4. Patients who experience restenosis, a myocardial infarction or suspected myocardial infarction between the baseline IVUS (Visit 1) and Visit 2 can only be entered into the single-blind period of the study if the affected vessel is not the coronary artery designated as the “target vessel” at the baseline IVUS study. If the target vessel is involved, the patient must be discontinued from the screening phase of the study prior to Visit 2. 5. Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left ventricular ejection fraction (LVEF) of < 25% as determined by contrast left ventriculography, radionuclide ventriculography or echocardiography. The absence of an LVEF measurement in a patient without a previous or current diagnosis of heart failure does not prohibit entry into the study. 6. Patients with evidence of cardiac electrophysiologic instability including a history of uncontrolled ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardia with a ventricular response heart rate of > 100 beats per minute at rest within 4 weeks prior to Visit 1. 7. Coronary artery bypass graft surgery &amp;#8804; 6 weeks of the date of the qualifying IVUS procedure. 8. Evidence of renal impairment as determined by any one of the following: Estimated Glomerular Filtration Rate (eGFR) < 40 ml/min/1.73 m2 using the MDRD formula at Visit 1 and Visit 2. A history of dialysis, macroalbuminuria (defined as a UACR &amp;#8805; 3000 mg/g) or nephrotic syndrome. 9. History or evidence of a secondary form of hypertension. 10. Known Keith-Wagener grade III or IV hypertensive retinopathy. 11. History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic cerebral attack (TIA) within 12 months of study entry. PLS SEE PROTOCOL
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint variable of this study is the change from baseline in percent atheroma volume (PAV)for all matched slices of anatomically comparable segments of the target coronary artery as assessed by IVUS evaluation after 104 weeks of treatment (single-blind and double-blind)
    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 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) 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.8.3 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-03-10. Yes
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 226
    F.4.2.2In the whole clinical trial 592
    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 Decision2009-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-01-31
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