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    Summary
    EudraCT Number:2015-001888-39
    Sponsor's Protocol Code Number:PGX-HT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-001888-39
    A.3Full title of the trial
    PHARMACOGENOMICS HYPERTENSION :
    A NEW APPROACH FOR PERSONALIZED MEDICINE ( PGX - HT )
    Farmaco-genomica dell'Ipertensione:
    un nuovo approccio per una medicina personalizzata (PGX-HT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHARMACOGENOMICS HYPERTENSION :
    A NEW APPROACH FOR PERSONALIZED MEDICINE ( PGX - HT )
    Farmaco-genomica Dell’ipertensione: Un Nuovo Approccio Per Una Medicina Personalizzata
    A.3.2Name or abbreviated title of the trial where available
    PGX-HT
    PGX-HT
    A.4.1Sponsor's protocol code numberPGX-HT
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOSPEDALE SAN RAFFAELE
    B.1.3.4CountryItaly
    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 supportMinistero della Salute - Italia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele - MI
    B.5.2Functional name of contact pointUnità di Genomica delle Malattie Re
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina, 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number0226433890
    B.5.5Fax number0226432384
    B.5.6E-mailpaolo.manunta@hsr.it
    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 PERINDOPRIL DOC GENERICI - 4 MG COMPRESSE 30 COMPRESSE IN BLISTER PVC/PVAC-AL
    D.2.1.1.2Name of the Marketing Authorisation holderDOC GENERICI SRL
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namePerindopril
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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) 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.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 Yes
    D.2.1.1.1Trade name ESIDREX - 25 MG COMPRESSE 20 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameesidrex
    D.3.2Product code C03AA03
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypertension
    Ipertensione
    E.1.1.1Medical condition in easily understood language
    Hypertension
    Ipertensione
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10051753
    E.1.2Term Vascular calcification
    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
    The primary objective of the study is to confirm a statistically significant difference in terms of reduction of diastolic and systolic blood pressure among patients carriers and non-carriers of the specific genetic profile for each drug ( HCTZ or Peri ) after 4/8 weeks of treatment .
    Obiettivo primario dello studio è confermare una differenza statisticamente significativa in termini di riduzione dei valori pressori diastolici e sistolici tra i pazienti portatori e non portatori del profilo genetico specifico per ogni farmaco (HCTZ o Peri) dopo 4/8 settimane di trattamento.
    E.2.2Secondary objectives of the trial
    Implementation of genetic profiles for HCTZ and Perindopril
    implementazione di profili genetici per HCTZ e Perindopril
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients aged between 25 and 60 years with newly diagnosed mild to moderate essential hypertension ( systolic blood pressure between 140 and 160 mmHg and diastolic blood pressure between 90 and 110 mmHg measured as the average of three consecutive measurements )
    I pazienti di età compresa tra 25 e 60 anni, con diagnosi recente di ipertensione arteriosa essenziale lieve o moderata (valori di pressione sistolica compresi tra 140 e 160 mmHg e valori di pressione diastolica compresi tra 90 e 110 mmHg rilevati come media di tre misurazioni consecutive),
    E.4Principal exclusion criteria
    Known causes of secondary hypertension ;
    - Pregnant women , nursing mothers or women of childbearing age taking anti - contraceptives ;
    - Severe hypertension or malignant ;
    - History of kidney disease ;
    - Significant renal disease ( creatinine clearance less than 60 ml / min ) ; anuria .
    - Hypokalemia or hyponatremia refractory ;
    - Hypercalcemia ;
    -iperuricemia symptomatic ;
    - Liver disease ;
    - Heart disease ( myocardial infarction , atrial fibrillation , etc. ) ;
    - Diabetes ( fasting glucose > 125 mg / dL ) ;
    - Treatment with statins ;
    - Obesity ( BMI > 30 kg / m2 ) ;
    -HYPERSENSITIVITY known to the study drugs ( ACE inhibitors , hydrochlorothiazide , sulphonamide derivatives ) or any of the excipients .
    -patients not capable of giving valid consent
    - cause note di ipertensione secondaria;
    - donne in stato di gravidanza o che allattano. -donne in età fertile che non acconsentono ad utilizzare metodi contraccettivi efficaci durante la somministrazione del trattamento in studio e per 90 giorni dopo l'interruzione del trattamentoi;
    - ipertensione grave o maligna;
    - storia di malattie dell'arteria renale;
    - malattia renale significativa (clearance della creatinina inferiore a 60 ml/min); anuria.
    - ipokaliemia o iponatriemia refrattarie;
    - ipercalcemia;
    -iperuricemia sintomatica;
    - malattia epatica;
    - patologie cardiache (infarto miocardico, fibrillazione atriale, ecc);
    - diabete (glicemia a digiuno >125mg/dL);
    - trattamento con statine;
    - obesità (BMI >30 kg/m2);
    -ipersensibilità nota verso i farmaci in studio (Ace-inibitori, idroclorotiazide, derivati solfonamidici) o a uno qualsiasi degli eccipienti.
    -pazienti non in grado di esprimere un valido consenso
    E.5 End points
    E.5.1Primary end point(s)
    reduction in blood pressure ( SBP / DBP ) higher in patients carrying the genetic profile ACEi or HCTZ versus patients with no genetic profile
    riduzione dei valori pressori (PAS/PAD) maggiore nei pazienti portatori del profilo genetico ACEi- riduzione dei valori pressori (PAS/PAD) maggiore nei pazienti portatori del profilo genetico HCTZ
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 4-8 weeks of treatment
    dopo 4-8 settimane di trattamento
    E.5.2Secondary end point(s)
    Implement the genetic profiles related to HCTZ and Perindopril
    Evaluate new genetic profiles in response to drugs Peri ndopril and HCTZ in terms of positive predictive value ( PPV ) and specificity
    Implementare i profili genetici preliminari per HCTZ e Perindopril
    Valutare i nuovi profili genetici nella risposta ai farmaci Peri e HCTZ in termini di Valore Predittivo Positivo (PPV) e Specificità
    E.5.2.1Timepoint(s) of evaluation of this end point
    4-8 weeks of treatments
    4-8 weeks of treatment
    4-8 settimane di trattamento
    4-8 settimane
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Si confrontano due gruppi con profili genetici diversi che assumono lo stesso farmaco (perindopril o
    It will be compared the two groups with different genetic profile within each antihypertensive drug
    E.8.2.4Number of treatment arms in the trial4
    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 concerned3
    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 No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    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 months36
    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.1.2.1Number of subjects for this age range: 300
    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 No
    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 state300
    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)
    No Programs
    Nessun Programma
    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 Decision2016-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-04
    P. End of Trial
    P.End of Trial StatusOngoing
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