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    Summary
    EudraCT Number:2014-001008-23
    Sponsor's Protocol Code Number:RIOP-1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-27
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-001008-23
    A.3Full title of the trial
    Riociguat in patients with respiratory disease and hypoxia – a proof-of-concept study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Riociguat in patients with respiratory disease hypoxia - a proof-of-concept study
    A.3.2Name or abbreviated title of the trial where available
    RIOPRED
    A.4.1Sponsor's protocol code numberRIOP-1
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN60323736
    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 SponsorThe Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNewcastle Clinical Trials Unit
    B.5.2Functional name of contact pointAndrea Rossi
    B.5.3 Address:
    B.5.3.1Street Address2nd Floor William Leech Building, Framlington Place
    B.5.3.2Town/ cityNewcastle upon Tyne
    B.5.3.3Post codeNE2 4HH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0) 191 208 8753
    B.5.5Fax number+44 (0) 191 208 8901
    B.5.6E-mailandrea.rossi@newcastle.ac.uk
    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 nameRiociguat
    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.3.9.3Other descriptive namemethyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazo-lo[3,4-b]pyridin-3-yl]-5-pyrimidinyl(methyl)carba
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 2.5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary hypertension WHO Group III (Pulmonary hypertension owing to lung disease and/or hypoxia):
    Chronic obstructive pulmonary disease(COPD);
    Pulmonary Fibrosis (PF).
    E.1.1.1Medical condition in easily understood language
    Respiratory disease and oxygen hypoxia
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10037400
    E.1.2Term Pulmonary hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 principal objective is to establish if Riociguat prevents the reduction of oxygen saturation and the consequent rise in pulmonary vascular resistance and pulmonary arterial pressure in patients with respiratory disease who have resting oxygen saturations between 90% and 95%.
    E.2.2Secondary objectives of the trial
    The secondary objective is to establish if Riociguat improve the oxygen saturation, breathlessness and diffusing capacity in patients with respiratory disease who have resting oxygen saturations between 90% and 95%.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 40 to 80 years, Male and Female

    Primary diagnosis of either chronic obstructive pulmonary disease (COPD) or pulmonary fibrosis (PF) with recent stability

    Capacity and willingness to provide fully informed consent for participation in the study
    E.4Principal exclusion criteria
    On prescribed nitrates (tablets or sublingual), dipyridamole, theophylline, warfarin, clopidogrel, rivaroxaban and dabigatran

    Other concomitant respiratory diagnoses including asthma, pulmonary hypertension (of any other aetiology), lung cancer, recent respiratory infection, recent acute pulmonary embolism, recent pneumothora

    Unable to give written, informed consent

    Contraindication to spirometry not included elsewhere: recent eye surgery, glaucoma

    Uncontrolled arterial hypertension (systolic BP > 180mmHg and/or diastolic BP > 110mmHg

    Systolic BP < 95mmHg

    Resting awake heart rate < 50 beats per minute or > 105bpm

    History of uncontrolled atrial fibrillation within 3 months of screening

    Left heart failure with an ejection fraction less than 40%

    Hypertrophic Obstructive Cardiomyopathy (HOCM)

    Proven or suspected active or recent* coronary artery disease

    Other active atherosclerotic disease: active peripheral arterial disease, stroke within 3 months of screening

    Significant valvular heart disease

    History of active or serious haemoptysis/pulmonary haemorrhage

    Hepatic dysfunction

    Bilirubin > 2 times ULN at screening and/or

    ALT or AST > 3 times ULN at screening and/or

    Albumin < 32g/L/hepatic encephalopathy > grade 1 at screening

    Renal insufficiency: GFR < 30ml/min

    Pregnant or lactating women.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in oxygen saturations (SaO2), mean pulmonary artery pressure(PAP),pulmonary vascular resistance (PVR)and perceived breathlessness during a hypoxic challenge test from base line to the end of the study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From stage 3 drug initiation to week 8
    E.5.2Secondary end point(s)
    The effect of Riociguat on diffusing capacity
    The effect of Riociguat on perceived breathlessness
    The Riociguat safety profile
    E.5.2.1Timepoint(s) of evaluation of this end point
    From stage 3 drug initiation)to week 8
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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.8.3 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.8.4.1Number of sites anticipated in Member State concerned1
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days14
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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)
    No treatment will be available after the trial and the participants will continue thier usual follow up arrangements with their Respiratory consultant or GP.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Newcastle Clinical Trials Unit
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-23
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