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    Summary
    EudraCT Number:2012-000868-15
    Sponsor's Protocol Code Number:PENT_PTA
    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:2012-06-08
    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 number2012-000868-15
    A.3Full title of the trial
    EFFECT OF TREATMENT WITH PENTOXIFYLLINE ABOUT THE RISK RATER OF POST-angioplasty restenosis IN PATIENTS WITH LOWER LIMB arterial disease
    EFFETTO DEL TRATTAMENTO CON PENTOSSIFILLINA SUL RISCHIO DI RESTENOSI POST-ANGIOPLASTICA IN PAZIENTI AFFETTI DA ARTERIOPATIA OBLITERANTE DEGLI ARTI INFERIORI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IMPACT ASSESSMENT OF ARTERIAL OCCLUSION AFTER TREATMENT WITH PENTOXIFYLLINE after angioplasty
    VALUTARE INCIDENZA OCCLUSIONE ARTERIOSA DOPO ANGIOPLASTICA DOPO TRATTAMENTO CON PENTOSSIFILLINA
    A.3.2Name or abbreviated title of the trial where available
    PENT_PTA
    A.4.1Sponsor's protocol code numberPENT_PTA
    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 SponsorUNIVERSITA' CAMPUS BIOMEDICO
    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 supportUNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
    B.5.2Functional name of contact pointGERIATRIA
    B.5.3 Address:
    B.5.3.1Street AddressVIA ALVARO DEL PORTILLO ,200
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00128
    B.5.3.4CountryItaly
    B.5.4Telephone number06225411350
    B.5.5Fax number06225411
    B.5.6E-mailc.pedone@unicampus.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 TRENTAL*IV 5F 100MG 5ML
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS SpA
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 6493-05-6Y
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100
    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
    PERIPHERAL ARTERIOPATHY
    ARTERIOPATIA OBLITERANTE ARTI INFERIORI
    E.1.1.1Medical condition in easily understood language
    PERIPHERAL ARTERIOPATHY
    ARTERIOPATIA ARTI INFERIORI
    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 SOC
    E.1.2Classification code 10047065
    E.1.2Term Vascular disorders
    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 effectiveness of treatment with pentoxifylline
    l’efficacia della terapia con pentossifillina
    E.2.2Secondary objectives of the trial
    whether and how the outcome of treatment with pentoxifylline in the long term is not influenced by hemodynamic variables
    verificare se e quanto l’esito della terapia con pentossifillina a lungo termine sia condizionato da variabili non emodinamiche
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age> 55 years
    - Moderate to severe arterial disease stage (Stage IIb and III sec. Fontaine)
    - walking capacity <150 m
    - Hemodynamic stenosis (> 50% of restriction of the vessel lumen) at the superficial femoral artery
    - Età &gt; 55 anni
    - arteriopatia obliterante stadio moderato-severo (Stadio IIb e III sec. Fontaine)
    - Autonomia di marcia &lt; a 150 mt
    - Stenosi emodinamica (&gt; al 50% di restrizione del lume vasale) a livello dell’arteria femorale superficiale
    E.4Principal exclusion criteria
    - Refusal of patients to participate in the study;
    - Cognitive deterioration (MMSE <24).
    - IRC severe (creatinine clearance <30 ml / minute)
    - Arterial leg stage IV sec. Fontaine
    - Rifiuto da parte dei pazienti di partecipare allo studio;
    - Deterioramento cognitivo (MMSE &lt; 24).
    - IRC severa (clearance &lt; 30 ml/minuto)
    - Arteriopatia arti inferiori stadio IV sec. Fontaine
    E.5 End points
    E.5.1Primary end point(s)
    - Test of the six-minute walk
    - Percutaneous oximetry (electrodes positioned lower third leg, the middle third of leg and dorsum of the foot limb revascularized)
    - Angio-MRI lower extremity
    - Dynamometry segmental level of the quadriceps and gastrocnemius muscle of the limb revascularized;
    - Test del cammino dei sei minuti
    - Ossimetria percutanea (elettrodo posizionato al III inferiore di coscia, al III medio di gamba e sul dorso del piede dell’arto rivascolarizzato)
    - Angio- RMN arti inferiori
    - Dinamometria segmentaria a livello del muscolo quadricipite e del muscolo gastrocnemio dell’arto rivascolarizzato;
    E.5.1.1Timepoint(s) of evaluation of this end point
    one month
    un mese
    E.5.2Secondary end point(s)
    - Evaluation of multidimensional (VMD) (which includes the MMSE, GDS, ADL, IADL)
    - EPIC questionnaire (questionnaire which aims to investigate the relationships between diet, environmental factors and lifestyle, and incidence of cancer and other chronic diseases).
    - PASE Questionnaire (questionnaire aims to assess the level of habitual physical activity of the patient)
    - Percutaneous segmental Oximetry: electrode placed at the lower third of thigh, the middle third of leg and dorsum of the foot to revascularize the limb;
    - Arterial blood gas analysis;
    - Segmental Dynamometry: estimating the strength of three different measurements at the level of the quadriceps muscle and gastrocnemius muscle from revascularize the limb;
    - Valutazione multidimensionale (VMD) (che include MMSE, GDS, ADL, IADL)
    - Questionario EPIC (questionario che ha lo scopo di investigare i rapporti tra dieta, fattori ambientali e dello stile di vita, ed incidenza di cancro e di altre malattie croniche).
    - Questionario PASE (questionario che ha lo scopo di valutare il livello di attività fisica abituale del paziente)
    - Ossimetria percutanea segmentaria: elettrodo posizionato al III inferiore di coscia, al III medio di gamba e sul dorso del piede dell’arto da rivascolarizzare;
    - Emogasanalisi arteriosa;
    - Dinamometria segmentaria: stimando su tre rilevazioni diverse la forza a livello del muscolo quadricipite e del muscolo gastrocnemio dell’arto da rivascolarizzare;
    E.5.2.1Timepoint(s) of evaluation of this end point
    one month
    un mese
    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 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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    TERAPIA STANDARD
    STANDARD THERAPY
    E.8.2.4Number of treatment arms in the trial2
    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 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 months15
    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.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state50
    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)
    STANDARD THERAPY
    NORMALE PRASSI CLINICA
    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 Decision2012-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-06
    P. End of Trial
    P.End of Trial StatusOngoing
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