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    Summary
    EudraCT Number:2016-000501-36
    Sponsor's Protocol Code Number:BAY63-2521/18694
    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:2021-05-27
    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 number2016-000501-36
    A.3Full title of the trial
    An open-label, multi-national, multi-center, single-arm, uncontrolled, longterm
    extension study of orally administered riociguat in patients with
    symptomatic pulmonary arterial hypertension (PAH) who received
    riociguat in a Bayer clinical trial
    Studio di estensione a lungo termine, in aperto, internazionale, multicentrico, a braccio singolo, non controllato, con riociguat somministrato per via orale a pazienti affetti da ipertensione arteriosa polmonare (PAH) sintomatica che hanno ricevuto riociguat in uno studio clinico di Bayer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An unblinded long-term extension study in different countries and centers
    on orally administered riociguat in patients with symptomatic pulmonary
    arterial hypertension (PAH) who received riociguat in a Bayer clinical trial
    Studio di estensione a lungo termine, in aperto, internazionale, multicentrico, a braccio singolo, non controllato, con riociguat somministrato per via orale a pazienti affetti da ipertensione arteriosa polmonare (PAH) sintomatica che hanno ricevuto riociguat in uno studio clinico di Bayer
    A.3.2Name or abbreviated title of the trial where available
    RIociguAt Long-Term ExtensiOn - RIALTO
    RIALTO
    A.4.1Sponsor's protocol code numberBAY63-2521/18694
    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 SponsorBAYER AG
    B.1.3.4CountryGermany
    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 supportBayer HealthCare
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer Pharma AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressM¿llerstrasse 178
    B.5.3.2Town/ cityBerlino
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.4Telephone number000
    B.5.5Fax number000
    B.5.6E-mailclinical-trials-contact@bayer.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 Yes
    D.2.1.1.1Trade name ADEMPAS - 0,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER PHARMA AG
    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/3/07/518
    D.3 Description of the IMP
    D.3.1Product nameAdempas 0.5 mg
    D.3.2Product code BAY63-2521
    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 INNRiociguat
    D.3.9.1CAS number 625115-55-1
    D.3.9.2Current sponsor codeBAY63-2521
    D.3.9.4EV Substance CodeSUB32880
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 2
    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 ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER PHARMA AG
    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/3/07/518
    D.3 Description of the IMP
    D.3.1Product nameAdempas 1.0 mg
    D.3.2Product code BAY63-2521
    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 INNRiociguat
    D.3.9.1CAS number 625115-55-1
    D.3.9.2Current sponsor codeBAY63-2521
    D.3.9.4EV Substance CodeSUB32880
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 3
    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 ADEMPAS - 1,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER PHARMA AG
    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/3/07/518
    D.3 Description of the IMP
    D.3.1Product nameRiociguat 1.5mg
    D.3.2Product code BAY63-2521
    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 INNRiociguat 1.5mg
    D.3.9.1CAS number 625115-55-1
    D.3.9.2Current sponsor codeBAY63-2521
    D.3.9.4EV Substance CodeSUB32880
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 4
    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 ADEMPAS - 2 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER PHARMA AG
    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/3/07/518
    D.3 Description of the IMP
    D.3.1Product nameAdempas 2.0mg
    D.3.2Product code BAY63-2521
    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 INNRiociguat 2.0mg
    D.3.9.1CAS number 625115-55-1
    D.3.9.2Current sponsor codeBAY63-2521
    D.3.9.4EV Substance CodeSUB32880
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 5
    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 ADEMPAS - 2,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 90 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER PHARMA AG
    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/3/07/518
    D.3 Description of the IMP
    D.3.1Product nameAdempas 2.5mg
    D.3.2Product code BAY63-2521
    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 INNRiociguat 2.5mg
    D.3.9.1CAS number 625115-55-1
    D.3.9.2Current sponsor codeBAY63-2521
    D.3.9.4EV Substance CodeSUB32880
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Hypertension, Pulmonary
    Ipertensione Polmonare
    E.1.1.1Medical condition in easily understood language
    Pulmonary arterial hypertension (PAH)
    Ipertensione Arteriosa Polmonare
    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 21.1
    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 provide riociguat therapy to eligible patients with PAH originating
    from the Bayer-sponsored trials 12935 PATENT-2 or 16719 RESPITE who
    are currently or recently treated in these trials until lack of patient
    benefit as assessed by investigator, or commercial availability and
    reimbursement.
    Fornire la terapia con riociguat a pazienti eleggibili affetti da ipertensione arteriosa polmonare (PAH) provenienti dagli studi clinici sponsorizzati da Bayer 12935 PATENT-2 o 16719 RESPITE che attualmente o recentemente sono in trattamento in questi studi fino al mancato beneficio per il paziente secondo la valutazione dello sperimentatore o in base alla disponibilit¿ sul mercato ed al rimborso.
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients diagnosed with PAH participating or having participated in
    the Bayersponsored studies 12935 or 16719, who have completed the
    main study phase and are still being treated with riociguat (either while
    still being on treatment with the respective study drug or by temporary
    commercial means with Adempas®) and who, in the opinion of the
    investigator, are expected to continue to have an overall positive
    benefit/risk from continuing treatment.
    2. Written informed consent.
    3. Women and men of reproductive potential must agree to use adequate
    contraception when sexually active. This applies for the time period
    between signing of the ICF and 30 days after the last administration of
    the study drug. 'Adequate contraception' is defined as use of
    combination of condoms with a safe and highly effective
    contraception method (hormonal contraception with implants or
    combined oral contraceptives, certain intrauterine devices).
    4. Women of reproductive potential must have a negative pregnancy test
    within 7 days of the first dose of study medication. A negative pregnancy
    test result from a test performed at the Termination Visit of the
    originating study can serve to comply with this inclusion criterion.
    Diagnosi
    Pazienti affetti da ipertensione arteriosa polmonare (PAH).
    Principali criteri di inclusione

    • Pazienti con diagnosi di PAH partecipanti attualmente o precedentemente agli studi 12935 o 16719 sponsorizzati da Bayer, che abbiano completato la fase principale dello studio e siano ancora in trattamento con riociguat (sia in corso di terapia con il rispettivo farmaco in studio o con il farmaco in commercio Adempas®) e che, a parere dello sperimentatore, abbiano un rapporto rischio/beneficio globale positivo proseguendo il trattamento.

    • Consenso informato scritto
    • Le donne e gli uomini in età fertile devono accettare di utilizzare una contraccezione adeguata se sessualmente attivi. Questo provvedimento si applica durante il periodo compreso tra la firma del modulo di consenso informato e 30 giorni dopo l’ultima somministrazione del farmaco in studio. La ‘Contraccezione adeguata” è definita come l’impiego di preservativi associato ad un metodo contraccettivo sicuro ed altamente efficace (contraccezione ormonale con impianti o contraccettivi orali associati, alcuni dispositivi intrauterini). Le donne in età fertile devono risultare negative al test di gravidanza entro 7 giorni dall’assunzione della prima dose del farmaco in studio.
    E.4Principal exclusion criteria
    1. Ongoing serious adverse event (SAE) from originating study that is
    assessed as related to riociguat.
    2. Pregnant women or breast-feeding women.
    3. Patients with a medical disorder, condition, or history of such that
    would impair the patient's ability to participate or complete this study in
    the opinion of the investigator or the sponsor.
    4. Pertinent non-compliance during originating study participation.
    5. Use of any contraindicated concomitant medications listed in the
    Adempas® SmPC.
    6. Any contraindication to Adempas® treatment listed in the SmPC.
    7. Previous assignment to treatment during this study.
    8. Concomitant participation in another clinical study with the study
    drug.
    9. Close affiliation with the investigational site; e.g. a close relative of
    the investigator, dependent person (e.g. employee or student of the
    investigational site).
    Principali criteri di esclusione
    • Evento avverso serio in corso manifestatosi nello studio di provenienza e giudicato correlato all’impiego di riociguat.
    • Donne incinte o che allattano
    • Pazienti che, secondo l’opinione dello sperimentatore o dello sponsor, presentino disturbi di natura medica, patologie o anamnesi tali da comprometterne la capacità di partecipare al presente studio o di completarlo.
    • Mancata aderenza del paziente durante la partecipazione allo studio di provenienza.
    • Impiego di qualunque farmaco concomitante controindicato elencato nel Riassunto delle Caratteristiche del Prodotto (RCP) di Adempas®.
    • Qualunque controindicazione al trattamento con Adempas® elencata nel RCP.
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable for this study is the number of patients with TEAEs
    La variabile primaria per questo studio è il numero di pazienti che presentino TEAE.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Study
    Fine studio
    E.5.2Secondary end point(s)
    NA
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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 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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 Information not present in EudraCT
    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 years3
    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 years3
    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.1.1.1In 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    It is at the discretion of the investigator to treat patients after end of
    trial with either marketed riociguat (Adempas) or any other treatment
    as deemed appropriate
    Dopo la fine dello studio a discrezione dello Sperimentatore il Paziente assumer¿ Adempas in commercio o altro trattamento adeguato
    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 Decision2016-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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