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    Summary
    EudraCT Number:2009-014992-31
    Sponsor's Protocol Code Number:AC-065A303
    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:2011-12-28
    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 number2009-014992-31
    A.3Full title of the trial
    Long-term, single-arm, open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension
    Studio a lungo termine, a singolo braccio, in aperto, per valutare la sicurezza e la tollerabilita' di ACT-293987 nei pazienti con ipertensione arteriosa polmonare
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension
    Studio per valutare se selexipag e` sicuro per il trattamento della ipertensione arteriosa polmonare
    A.3.2Name or abbreviated title of the trial where available
    GRIPHON-OL
    GRIPHON-OL
    A.4.1Sponsor's protocol code numberAC-065A303
    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 SponsorActelion Pharmaceuticals Ltd
    B.1.3.4CountrySwitzerland
    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 supportActelion Pharmaceuticals Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationActelion Pharmaceuticals Ltd
    B.5.2Functional name of contact pointGlobal Medical Information
    B.5.3 Address:
    B.5.3.1Street AddressGewerbestrasse 16
    B.5.3.2Town/ cityAllschwil
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number.
    B.5.5Fax number.
    B.5.6E-mailmedinfo_ch@actelion.com
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/316
    D.3 Description of the IMP
    D.3.2Product code ACT-293987
    D.3.4Pharmaceutical form 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 INNSELEXIPAG
    D.3.9.2Current sponsor codeACT-293987
    D.3.9.4EV Substance CodeND
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Pulmonary Arterial Hypertension
    Ipertensione Polmonare Arteriosa
    E.1.1.1Medical condition in easily understood language
    Pulmonary arterial hypertension is an increase in blood pressure in the pulmonary arteries leading to shortness of breath, dizziness, fainting and other symptoms.
    L`ipertensione arteriosa polmonare consiste in un aumento della pressione sanguigna nelle arterie polmonari che determina sintomi quali fiato corto, capogiri, stanchezza ed altri.
    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 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
    To assess the long-term safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension (PAH).
    Valutare a lungo termine la sicurezza e tollerabilita' di ACT-293987 nei pazienti con Ipertensione Arteriosa Polmonare (PAH)
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed informed consent prior to initiation of any study-mandated procedure. - Patients who have completed the double-blind study AC-065A302 as scheduled per protocol (i.e., treated until unblinding of the study), or who have experienced a clinical worsening of PAH (adjudicated by the CEC) during study AC-065A302. - Women of child-bearing potential included in study AC-065A303 must use a reliable method of contraception (with a failure rate of less than 1% per year) until one month after study drug discontinuation.
    - Consenso informato firmato prima di iniziare qualsiasi procedura prevista dallo studio - Pazienti che hanno completato lo studio in doppio cieco AC-065A302 come da protocollo (cioe`, trattati fino all`apertura del cieco dello studio) oppure che hanno avuto un peggioramento clinico dell’Ipertensione Arteriosa Polmonare (aggiudicato dal Comitato per gli Eventi Critici (Critical Event Committee, CEC)) nello studio AC-065A302 - Donne in eta` fertile1 incluse nello studio AC-065A303 devono fare uso di un metodo contraccettivo affidabile (con un tasso di fallimento annuo inferiore all’1%) fino ad un mese dopo l’interruzione del trattamento con il farmaco in studio
    E.4Principal exclusion criteria
    - Any major violation of protocol AC-065A302. - Females who plan to become pregnant during the study, or are breastfeeding. - Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence, or psychiatric disease. - Known hypersensitivity to ACT-293987 or any of the excipients.
    - Pazienti con qualsiasi violazione importante al protocollo AC-065A302 - Donne che hanno intenzione di programmare una gravidanza nel corso dello studio, oppure sono in allattamento - Pazienti con qualsiasi fattore o patologia conosciuto/a, che potrebbe interferire con il conformarsi al trattamento, la conduzione dello studio o l’interpretazione dei risultati, come ad esempio dipendenza da droghe o alcool, o disturbi psichici - Pazienti con ipersensibilita` nota a ACT-293987 o ad uno qualsiasi degli eccipienti
    E.5 End points
    E.5.1Primary end point(s)
    No primary efficacy endpoint is considered for this OL study. The primary endpoint for this study is safety and tolerability.
    Nessun endpoint primario di efficacia viene considerato per questo studio, il cui endpoint primario e' la sicurezza e la tollerabilita'.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After Visit 5, safety will be assessed every 6 months
    Dopo la Visita 5, la sicurezza sara' valutata ogni 6 mesi
    E.5.2Secondary end point(s)
    ND
    ND
    E.5.2.1Timepoint(s) of evaluation of this end point
    ND
    ND
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilita'
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belarus
    Canada
    Chile
    China
    India
    Israel
    Korea, Republic of
    Malaysia
    Mexico
    Peru
    Russian Federation
    Singapore
    Switzerland
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Study treatment for each patient lasts from his/her Visit 1 date until the end of the trial i.e., until whichever of the following occurs first: (i) the approval of ACT-293987 in this indication is obtained in the patient`s country, (ii) the sponsor decides to stop study AC- 065A303/GRIPHON OL, or (iii) the patient, or the investigator decide to discontinue study drug.
    Il trattamento dura da V1 a Fine Studio, a seconda di quale dei seguenti casi avviene prima: 1.Approvazione di ACT-293987 per l`indicazione nel paese del paziente; 2.Sponsor interrompe studio; 3. paziente o PI interrompere trattamento in studio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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.1.2.1Number of subjects for this age range: 447
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 223
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 670
    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)
    ND
    ND
    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 Decision2010-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-20
    P. End of Trial
    P.End of Trial StatusCompleted
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