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    Summary
    EudraCT Number:2011-002018-35
    Sponsor's Protocol Code Number:ARC209/A
    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:2012-10-30
    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 number2011-002018-35
    A.3Full title of the trial
    SPHERIC-1OE (Sildenafil and Pulmonary HypERtension In COPD – Open Extension) - A multicenter, longitudinal, 12 months open-label study, for the observation of the use of sildenafil in the treatment of patients with pulmonary hypertension associated to chronic obstructive lung disease enrolled in SPHERIC-1 study
    SPHERIC-1OE (Sildenafil nelle Pneumopatie ostruttive cHE pResentano Ipertensione Polmonare Cronica – Open Extension) - Studio multicentrico, longitudinale, in aperto, della durata di 12 mesi, per l’osservazione dell’utilizzo di sildenafil nel trattamento dei pazienti con ipertensione polmonare associata a BPCO arruolati nello Studio SPHERIC-1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SPHERIC-1OE: study of the duration of 12 months for the observation of the use of sildenafil for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease in patients enrolled in the previous study titled SPHERIC-1
    SPHERIC-1OE: studio della durata di 12 mesi per l'osservazione dell’utilizzo di sildenafil per il trattamento dell’ipertensione polmonare associata a broncopneumopatia cronica ostruttiva nei pazienti arruolati nel precedente studio denominato SPHERIC-1
    A.3.2Name or abbreviated title of the trial where available
    SPHERIC-1 OPEN EXTENSION
    SPHERIC-1 OPEN EXTENSION
    A.4.1Sponsor's protocol code numberARC209/A
    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 SponsorASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERI
    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 supportASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERI
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportPFIZER ITALIA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERI
    B.5.2Functional name of contact pointCENTRO STUDI AIPO
    B.5.3 Address:
    B.5.3.1Street AddressVIA ANTONIO DA RECANATE 2
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20124
    B.5.3.4CountryItaly
    B.5.4Telephone number0236590352
    B.5.5Fax number0267382337
    B.5.6E-mailaipocentrostudi@aiporicerche.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.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/03/178
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSILDENAFIL CITRATE
    D.3.9.1CAS number 171599-83-0
    D.3.9.4EV Substance CodeSUB04386MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Patients with pulmonary hypertension associated with chronic obstructive pulmonary disease enrolled in the study SPHERIC-1
    Pazienti con ipertensione polmonare associata a broncopneumopatia cronica ostruttiva arruolati nello studio SPHERIC-1
    E.1.1.1Medical condition in easily understood language
    Patients with pulmonary hypertension and chronic obstructive pulmonary disease
    Pazienti con ipertensione polmonare e broncopneumopatia cronica ostruttiva
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Observation of the use of sildenafil for pulmonary hypertension associated with COPD in patients enrolled in the previous clinical trial titled SPHERIC-1
    Osservazione dell’utilizzo di sildenafil nel trattamento dell’ipertensione polmonare associata a BPCO nei pazienti arruolati nel precedente studio clinico denominato SPHERIC-1
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients enrolled in the study SPHERIC-1 who completed the study with stable COPD in optimal pharmacological treatment (Eur Respir J 2004; 23: 932-946), chronic oxygen therapy in patients with hypoxia, with PaO2 at rest ≥ 60 mmHg and PaCO2 ≤ 55 mmHg, aged between 18 and 80 years old
    Pazienti arruolati nello studio SPHERIC-1 che hanno completato lo studio con BPCO stabile in ottimale trattamento farmacologico (Eur Respir J 2004; 23: 932-946) e in O2 terapia a lungo termine se ipossiemici, con PaO2 a riposo in aria o corretta ≥ 60 mmHg e PaCO2 ≤ 55 mmHg, di età compresa fra i 18 e gli 80 anni
    E.4Principal exclusion criteria
    Exlusion criteria as previous study SPHERIC-1: • Different types of pulmonary hypertension (chronic,
    thromboembolic pulmonary hypertension, pulmonary arterial
    hypertension etc.) • Significant left cardiac disease (LVEF <45%,
    cardiomyopathy, valvulopathy, unstable coronaropathy) •
    Treatment with nitrates in the last 10 days, or in need of other
    nitrate therapy for different diseases • Treatment with other
    specific drugs for arterial pulmonary hypertension (less than 4
    weeks) • Significant systemic disease other than COPD • Recent
    reacutization of chronic bronchitis (< 4 weeks) • Pregnancy or
    breastfeeding, or women without an adequate contraceptive
    method for the whole study duration • History of anaphylaxys or
    allergic reactions to 5-phosphodiesterase inhibitors • Cancers
    within the last 5 years with the exception of localized cancers of
    the skin or of the cervix • Hepatic insufficiency or chronic renal
    failure or hemoglobinemia < 10 g/dL during the screening phase •
    Contraindications to subministration as per SPC • Mental disorder,
    alcohol abuse, chronic alcoholism, drug abuse • Subjects unable to
    sign the informed consent form • Subjects unable to walk
    I criteri di esclusione sono uguali a quelli indicati nel precedente studio SPHERIC-1: • Altre forme di ipertensione polmonare (ipertensione polmonare
    cronica trombo embolica, ipertensione arteriosa polmonare, ecc.) •
    Significativa malattia cardiaca sinistra (LVEF &lt;45%,
    cardiomiopatie, valvulopatie, coronaropatia instabile) •
    Trattamento con i nitrati negli ultimi 10 giorni, o necessita' di una
    terapia di nitrato per altre malattie • Trattamento con altri farmaci
    specifici per l'ipertensione arteriosa polmonare (da meno di 4
    settimane) • Significativa malattia sistemica diversa da BPCO •
    Recente riacutizzazione bronchitica (&lt; 4 settimane) • Donne in
    gravidanza o in allattamento, oppure donne in eta' fertile che non
    facciano uso di adeguati metodi anticoncezionali per tutta la durata
    dello studio • Storia di anafilassi o reazioni allergiche ai derivati
    degli inibitori della fosfodiesterasiā€5 • Presenza di malattia tumorale
    entro 5 anni ad eccezione di carcinomi localizzati della cute o della
    cervice • Insufficienza epatica o insufficienza renale cronica o
    emoglobinemia &lt; 10 g/dL allo screening • Controindicazioni alla
    somministrazione del farmaco secondo quanto riportato in scheda
    tecnica • Instabilita' mentale, abuso di alcool o alcolismo cronico,
    uso di droghe • Soggetti non in grado di firmare un consenso
    informato • Soggetti non in grado di deambulare
    E.5 End points
    E.5.1Primary end point(s)
    Registration of any adverse events during administration of sildenafil citrate 20 mg every 8 hours for 12 months
    Rilevazione di eventuali eventi avversi durante la somministrazione di sildenafil citrato 20 mg ogni 8 ore per 12 mesi
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months (visits at 3 and 6 month or according to clinical practice)
    12 mesi (con visite di controllo a 3 e 6 mesi o secondo la pratica clinica)
    E.5.2Secondary end point(s)
    Not applicable
    Non applicabile
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Non applicabile
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) 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 trial1
    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 concerned7
    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 months12
    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: 20
    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
    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)
    NA
    NA
    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 Decision2013-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
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