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    Summary
    EudraCT Number:2011-000785-35
    Sponsor's Protocol Code Number:PAIR
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-03-05
    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 number2011-000785-35
    A.3Full title of the trial
    A PROSPECTIVE STUDY TO ASSESS THE INTERACTION BETWEEN PATIENT GENOTYPE AND ROSTAFUROXIN EFFECTS ON ARTERIAL BLOOD PRESSURE AND KIDNEY FUNCTION IN NEVER-TREATED HYPERTENSIVE TYPE 2 DIABETES PATIENTS (AN OPEN LABEL STUDY WITH BLINDED PATIENT GENOTYPE)
    STUDIO DELL'INTERAZIONE TRA GENOTIPO ED EFFETTO DELLA ROSTAFUROXINA SU PRESSIONE ARTERIOSA E FUNZIONALITA' RENALE IN PAZIENTI CON DIABETE TIPO 2 ED IPERTENSIONE ARTERIOSA MAI TRATTATA
    A.3.2Name or abbreviated title of the trial where available
    Rostafuroxin (PST2238) in Type 2 diabetes
    Rostafuroxina in pazienti diabetici di tipo 2
    A.4.1Sponsor's protocol code numberPAIR
    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 SponsorIST. DI RICERCHE FARMACOLOG. M. NEGRI
    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 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 namerostafuroxin
    D.3.2Product code PST2238
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNrostafuroxin
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codePST2238
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.3Concentration number500
    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
    Type 2 Diabetes.
    Diabete di tipo 2.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10015491
    E.1.2Term Essential hypertension, unspecified
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10012612
    E.1.2Term Diabetes mellitus non insulin-dep
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the reduction in office systolic BP and albuminuria (mean of three consecutive measurements in 24-hour urine collections) after 5 weeks Rostafuroxin therapy between two subsets of hypertensive type 2 diabetic patients with or without a pre-defined genetic profile (Profile 1) expected to be associated with adducin/ouabain dependent arterial hypertension and glomerular dysfunction.
    Paragonare la riduzione della pressione sistolica e dell’albuminuria (media di tre misurazioni consecutive nella raccolta urinaria delle 24 ore) dopo 5 settimane di trattamento con Rostafuroxina tra i due sottogruppi di pazienti ipertesi con diabete di tipo 2 con o senza il profilo genetico descritto nell’Appendice 1 al protocollo, associato ad ipertensione arteriosa e disfunzione glomerulare adducina/ouabaina dipendente. .
    E.2.2Secondary objectives of the trial
    • To compare between-group treatment-induced changes in the following parameters: - In office diastolic, mean and pulse BP; - Mean 24-hour systolic, diastolic, mean and pulse BP; - Day-time and night-time systolic, mean, diastolic and pulse BP; - Pulse wave velocity and other markers of vascular stiffness; - Glomerular filtration rate (as measured by the iohexol plasma clearance); - Albumin and IgG fractional clearance. • To explore the relationships between treatment-induced changes in office and 24-hour BP and concomitant changes in albuminuria in the study group as a whole and within each genotype group considered separately. • To assess treatment safety and tolerability (by evaluation of vital signs and routine laboratory parameters) in the study group as a whole and within each genotype group considered separately. • To explore the possibility that the response to Rostafuroxin is confined or present in the subset of patients carrying the profile 1
    • Paragonare tra i due gruppi i cambiamenti indotti dal trattamento sui seguenti parametri: - Pressione arteriosa diastolica, media e curva di pressione in ambulatorio; - Pressione sistolica, diastolica, media e curva di pressione delle 24 ore; - Pressione sistolica, diastolica, media e curva di pressione delle 24 ore durante il giorno e durante la notte; - Frequenza del polso e altri marcatori di rigidita' vascolare; - Velocita' di filtrazione glomerulare (misurata come clearance plasmatica dello ioexolo); - Clearance frazionata dell’albumina e delle IgG. • Esplorare la relazione tra i cambiamenti indotti dai due trattamenti nella pressione in ambulatorio e delle 24 ore, e i cambiamenti nell’albuminuria nel gruppo in studio nel suo complesso e all’interno di ciascun genotipo considerato separatamente. • Esplorare la possibilita' che la risposta alla Rostafuroxina sia confinata al gruppo che presenta un certo genotipo o presente in entrambi i gruppi.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female patients; - Age > 18 years; - Hypertensive type 2 diabetes never-treated office systolic BP >135 mmHg in at least two consecutive visits one week apart (see Appendix 2); - High-normal, micro- or macro- albuminuria (urinary albumin excretion >10 mg/24 hours); - Normal kidney function (serum creatinine levels <1.4 mg/dl); - Capable of understanding the purpose of the study; - Written informed consent (signed and dated by the patient).
    - Uomini e donne di eta' superiore ai 18 anni; - Pazienti diabetici di tipo 2 ipertesi mai trattati con pressione sistolica in ambulatorio &gt;135 mmHg in almeno due visite consecutive eseguite ad una settimana di distanza (vedi Appendix 2); - Escrezione urinaria di albumina &gt;10 mg/24 hours; - Funzione renale normale (creatinina sierica &lt;1.4 mg/dl); - Capacita' di comprendere gli obiettivi dello studio; - Consenso informato scritto (firmato e datato dal paziente).
    E.4Principal exclusion criteria
    - Concomitant treatment with drugs potentially affecting arterial BP, albuminuria or kidney function; - Secondary or grade 3 or more arterial hypertension (according to 2007 ESH/ESC Hypertension guidelines); - Non-diabetic renal disease, urinary tract infection, cardiovascular events over the last six months; - Any clinically relevant conditions that might affect study participation and/or study results; - Any contraindication to be exposed to Rostafuroxin; - Pregnancy or lactating; - Women of childbearing potential without following a scientifically accepted form of contraception; - Legal incapacity.
    - Trattamenti concomitanti con farmaci che possano avere effetto sulla pressione, sull’albuminuria o sulla funzione renale; - Ipertensione arteriosa secondaria, di grado 3 o superiore (in accordo con le Linee Guida ESH/ESC sull’ipertensione del 2007)4; - Malattia renale non-diabetica, infezioni delle vie urinarie, eventi cardiovascolari nei sei mesi precedenti l’inizio dello studio; - Qualsiasi condizione clinica rilevante che possa compromettere la partecipazione allo studio e/o i risultati dello studio stesso; - Qualsiasi controindicazione all’assunzione di Rostafuroxin; - Gravidanza o allattamento; - Donne potenzialmente fertili che non utilizzino metodi contraccettivi scientificamente approvati; - Incapacita' legale.
    E.5 End points
    E.5.1Primary end point(s)
    - Office systolic BP - Albuminuria (mean of three consecutive measurements in 24-hour urine collections)
    - Pressione sistolica misurata in ambulatorio - Albuminuria (media di tre misurazioni consecutive sulla raccolta delle 24 ore)
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    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
    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 months18
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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 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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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 Decision2011-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-03-21
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