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    Summary
    EudraCT Number:2006-004774-27
    Sponsor's Protocol Code Number:ART108053
    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:2007-04-03
    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 number2006-004774-27
    A.3Full title of the trial
    An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications- Comparison of Arixtra in lower LImb Superficial Thrombophlebitis with placebO (CALISTO)
    An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications- Comparison of Arixtra in lower LImb Superficial Thrombophlebitis with placebO (CALISTO)
    A.3.2Name or abbreviated title of the trial where available
    CALISTO
    A.4.1Sponsor's protocol code numberART108053
    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 SponsorGLAXOSMITHKLINE R&D Ltd
    B.1.3.4CountryUnited Kingdom
    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 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 nameFondaparinux sodico
    D.3.2Product code GSK576428
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFondaparinux
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.3Concentration number2500
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs
    Pazienti con tromboflebite superficiale acuta sintomatica degli 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 PT
    E.1.2Classification code 10043595
    E.1.2Term Thrombophlebitis superficial
    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 demonstrate the superior efficacy of fondaparinux 2.5 mg once daily versus placebo with respect to the occurrence of symptomatic VTE and/or death from any cause up to Day 45 (end of treatment period) in patients with isolated ST of the lower limbs.
    L'obiettivo primario dello studio e' dimostrare l'efficacia di fondaparinux 2,5 mg una volta al giorno rispetto a placebo relativamente al manifestarsi dell'endpoint primario di efficacia (eventi sintomatici di VTE e/o morte) dovuto ad una qualsiasi causa fino al giorno 45 (fine del periodo di trattamento) nei pazienti con ST isolata degli arti inferiori.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to demonstrate the efficacy of fondaparinux 2.5 mg once daily versus placebo with respect to the occurrence of symptomatic VTE events and/or death from any cause up to Day 75 (end of follow-up) in patients with isolated ST of the lower limbs The principal safety endpoint will also be evaluated up to Day 75. Other safety objectives of the study are to evaluate the overall safety of fondaparinux 2.5 mg once daily versus placebo with respect to symptomatic arterial thromboembolic events and other adverse events (AE).
    L`obiettivo secondario dello studio e` dimostrare l`efficacia di fondaparinux 2,5 mg una volta al giorno rispetto a placebo relativamente al manifestarsi di eventi sintomatici di VTE e/o morte dovuti ad una qualsiasi causa fino al giorno 75 (fine del periodo di follow-up) nei pazienti con ST isolata degli arti inferiori.Anche il principale endpoint di sicurezza verra` valutato fino al giorno 75.Altri obiettivi di sicurezza dello studio sono la valutazione della sicurezza complessiva di fondaparinux 2,5 mg una volta al giorno rispetto a placebo relativamente ad episodi tromboembolici arteriosi sintomatici ed altri eventi avversi (AE)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Hospitalised or non-hospitalised male or female patients 18 years of age or greater • With acute symptomatic isolated ST of the lower limbs at least 5 cm long documented by standard CUS • Able and willing to provide written informed consent.
    • pazienti uomini e donne di almeno 18 anni di eta' ospedalizzati o non ospedalizzati, • presenza di ST acuta isolata sintomatica degli arti inferiori di almeno 5 cm di lunghezza documentata da una CUS standard, • capacita' e volonta' di fornire il consenso informato scritto.
    E.4Principal exclusion criteria
    ST following sclerotherapy or resulting as a complication of an intravenous line, • Palpable hard cord without any inflammation and, on CUS, with an anteroposterior diameter < 5 mm and uniformly hyperechoic (high probability of old ST), • Delay between symptom onset and randomisation greater than 21 days, • Delay between diagnosis by CUS and randomisation greater than 48 hours (exceptionally, if the delay between CUS and randomisation exceeds this time period, the patient may be randomised if eligibility is confirmed by repeat CUS), • Treatment of the current episode of ST with antithrombotic or anticoagulant therapy, including low-dose anticoagulation, for more than 48 hours prior to randomisation, • Treatment of the current episode of ST with oral NSAIDs for more than 72 hours prior to randomisation, • Treatment of the current episode of ST with aspirin at doses greater than 325 mg per day for more than 72 hours prior to randomisation, • ST within 3 cm from the sapheno-femoral junction, • Symptomatic or asymptomatic DVT on qualifying CUS, • Documented presence of symptomatic PE, • Requirement for ligation of the sapheno-femoral junction, thrombectomy or planned intervention for stripping of varicose veins during the study period, • History of documented ST occurring within the last 90 days, • History of documented DVT or PE within the last six months, • ST in patients with active cancer . Anticoagulant therapy required or likely to be required during the study period (e.g. planned surgery justifying pharmacological thromboprophylaxis) • Treatment with aspirin at a dose greater than 325 mg per day or oral NSAIDs (at any dose) required or likely to be required during the study period -Known hypersensitivity to fondaparinux or its excipient, • Women of childbearing potential not using a reliable contraceptive method throughout the study period (a list of reliable contraceptive methods is provided in Section 11.3, Appendix 3) • Pregnant or breast-feeding women during the study period. Active, clinically significant bleeding, • Clinically significant bleeding within the past month, • Patient judged by the investigator to be at high risk of bleeding, • Major surgery within the previous three months, • Ophthalmic, spinal, and/or brain surgery within the previous twelve months, • Haemorrhagic stroke within the previous twelve months, • Severe head injury within the previous three months, • Documented congenital or acquired bleeding tendency/disorder(s), • Previous or active peptic ulcer disease, • Uncontrolled arterial hypertension (systolic blood pressure over 180 mm Hg or diastolic blood pressure over 110 mm Hg), • Treatment with more than one antiplatelet agent (e.g. clopidogrel and aspirin) at any dose, • Bacterial endocarditis, • Severe hepatic impairment, • Platelet count below 100×109/L, • Prothrombin time ratio below 50%, • Calculated creatinine clearance < 30 mL/min • Body weight < 50 kg. • Any condition that could prevent the patient from providing written informed consent or from adhering to study treatment, • Life expectancy under three months, • Participation in any study using an investigational drug during the previous three months • Patient in whom follow-up to Day 75 is unlikely to be feasible (e.g. patient moving to another country).
    • ST dopo scleroterapia o risultante da una complicazione di una linea endovenosa • cordone duro palpabile senza alcuna infiammazione e, alla CUS, con un diametro antero-posteriore &lt; 5 mm e uniformemente iperecoico (elevata probabilita' di ST vecchia) ritardo tra l'esordio del sintomo e la randomizzazione superiore a 21 giorni • ritardo tra la diagnosi dalla CUS e la randomizzazione superiore a 48 ore (in via eccezionale, se il ritardo tra la CUS e la randomizzazione supera questo periodo di tempo, il paziente puo' essere randomizzato se l'eleggibilita' viene confermata da una ripetizione della CUS)• trattamento della di ST in corso con terapia antitrombotica o anticoagulante, compresa un'anticoagulazione a bassa dose, per piu' di 48 ore prima della randomizzazione • trattamento della di ST in corso con FANS orali per piu' di 72 ore prima della randomizzazione • trattamento della di ST in corso con aspirina a dosi superiori a 325 mg al giorno per piu' di 72 ore prima della randomizzazione • ST entro 3 cm dalla giunzione safeno-femorale • DVT sintomatica o asintomatica alla CUS di ammissione • presenza documentata di PE sintomatica • esigenza di una legatura della giunzione safeno-femorale, trombectomia o intervento programmato per eliminazione di vene varicose durante il periodo dello studio • storia di ST documentata che si e' verificata entro gli ultimi 90 giorni • storia di DVT documentata o PE negli ultimi sei mesi • ST in pazienti con cancro attivo (cioe' trattati per cancro negli ultimi sei mesi) • terapia anticoagulante richiesta o che probabilmente sara' necessaria durante il periodo dello studio • trattamento con aspirina a dosi superiori a 325 mg al giorno o con FANS orali (a qualsiasi dose) richiesto o che probabilmente sara' necessario durante il periodo dello studio • ipersensibilita' nota a fondaparinux o ai suoi eccipienti • • donne potenzialmente fertili che non utilizzano un metodo contraccettivo affidabile per tutta la durata dello studio (un elenco dei metodi di contraccezione accettabili e' fornito nella sezione 11.3, appendice 3 del protocollo) • donne in gravidanza o in allattamento durante il periodo dello studio • sanguinamento attivo e clinicamente significativo • sanguinamento clinicamente significativo nell'ultimo mese • paziente a rischio di sanguinamento a giudizio dello sperimentatore • chirurgia maggiore nei tre mesi precedenti • chirurgia oftalmica, spinale, e/o cerebrale nei dodici mesi precedenti • ictus emorragico nei dodici mesi precedenti • ferita grave alla testa nei tre mesi precedenti • disordine (i)/tendenza congenita o acquisita documentata • ulcera peptica precedente o attiva • ipertensione arteriosa non controllata (pressione sanguigna sistolica al di sopra di 180 mm Hg o pressione sanguigna diastolica al di sopra di 110 mm Hg) • trattamento con piu' di un agente antipiastrinico (ad es. clopidogrel e aspirina) a qualsiasi dose • endocardite batterica • insufficienza epatica grave • conta piastrinica inferiore a 100×109/L • rapporto del tempo di protrombina inferiore al 50% • clearance della creatinina calcolata &lt; 30 mL/min • peso corporeo &lt; 50 kg • qualsiasi condizione che possa impedire al paziente di fornire il consenso informato scritto o di aderire al trattamento dello studio • aspettativa di vita inferiore a tre mesi • partecipazione durante i tre mesi precedenti ad un qualsiasi studio che utilizzi un farmaco sperimentale • paziente per il quale il follow-up al giorno 75 non sia probabilmente realizzabile (ad es. paziente che sta per traslocare in un altro paese)
    E.5 End points
    E.5.1Primary end point(s)
    The main safety objective of the study is to evaluate fondaparinux 2.5 mg once daily versus placebo with respect to the occurrence of major bleeding and death up to Day 49(end of treatment period plus four days) in patients with isolated ST of the lower limbs. The primary efficacy endpoint is VTE and/or death from any cause up to Day 45 (end of study treatment period). VTE is defined in this study as a composite of symptomatic PE, symptomatic DVT, symptomatic recurrence of ST or symptomatic extension of ST.
    Il principale endpoint di sicurezza dello studio e' valutare fondaparinux 2,5 una volta al giorno rispetto a placebo relativamente al manifestarsi di un sanguinamento maggiore e/o morte fino al giorno 49 (fine del periodo di trattamento piu' quattro giorni) nei pazienti con ST isolata degli arti inferiori. L'endpoint primario di efficacia e' un VTE e/o morte dovuti ad una qualsiasi causa fino al giorno 45. Il VTE e' definito come un insieme di PE sintomatica, DVT sintomatica, ricomparsa sintomatica di ST o estensione sintomatica di ST.
    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.8.2.4Number 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 months24
    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 months24
    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.1.1Number 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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2500
    F.4.2.2In the whole clinical trial 2500
    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 Decision2007-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-31
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