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    Summary
    EudraCT Number:2018-001187-33
    Sponsor's Protocol Code Number:APD811-301
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-12-18
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-001187-33
    A.3Full title of the trial
    A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.
    A.3.2Name or abbreviated title of the trial where available
    ADVANCE-outcomes
    A.4.1Sponsor's protocol code numberAPD811-301
    A.5.4Other Identifiers
    Name:IND NumberNumber:109021
    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 SponsorArena Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportArena Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArena Pharmaceuticals Inc.
    B.5.2Functional name of contact pointSonia Villegas
    B.5.3 Address:
    B.5.3.1Street Address6154 Nancy Ridge Drive
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1858-529-2475
    B.5.6E-mailsvillegas@arenapharm.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRalinepag
    D.3.2Product code APD811
    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 INNralinepag
    D.3.9.1CAS number 1187856-49-0
    D.3.9.2Current sponsor codeAPD811
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.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 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 nameRalinepag
    D.3.2Product code APD811
    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 INNralinepag
    D.3.9.1CAS number 1187856-49-0
    D.3.9.2Current sponsor codeAPD811
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.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 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 nameRalinepag
    D.3.2Product code APD811
    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 INNralinepag
    D.3.9.1CAS number 1187856-49-0
    D.3.9.2Current sponsor codeAPD811
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    pulmonary arterial hypertension (PAH)
    E.1.1.1Medical condition in easily understood language
    high lung blood pressure
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077731
    E.1.2Term Pulmonary hypertension WHO functional class I
    E.1.2System Organ Class 100000004855
    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 this study is:
    To compare the effect of ralinepag versus placebo in subjects with standard of care or PAH-specific background therapy on disease progression and achievement of a satisfactory clinical response in subjects with WHO Group 1 PAH.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    1) To evaluate the effects of ralinepag on the following parameters:
    • N-terminal pro b-type natriuretic peptide (NT-proBNP)
    • 6 minute walk distance (6MWD)
    • WHO/ New York Heart Association (NYHA) functional class
    • Time to all-cause hospitalization
    • Time to all-cause mortality
    • Heart rate recovery (HRR) following completion of the 6-minute walk test (6MWT)
    • Proportion of subjects who attain all three of the following (at specified time points):
    o NT-proBNP <300 pg/mL
    o 6MWD >440 meters
    o WHO/NYHA functional class II status or better

    • Health-related quality of life (HRQoL) measures
    2) To assess ongoing safety and tolerability of ralinepag when added to standard of care or PAH-specific background therapy.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Cardiac Magnetic Resonance Imaging (cMRI) Substudy:
    An MRI substudy to assess the change in right ventricular size and function is planned at selected sites. A substudy to evaluate the effect of ralinepag by cardiac magnetic resonance imaging (cMRI) will be performed at selected sites to evaluate functional changes in the right heart (i.e. enhanced volume and pressure measurements by visualization and direct measurement of anatomical and
    cMRI-derived parameters, such as right ventricular (RV) volumes and ejection fraction. This substudy will be performed as in a separate protocol and cMRI manual.
    2. Proteomics, Metabolomics, and Gene Expression Substudy:
    A substudy to evaluate the effect of ralinepag on proteomics and gene expression is planned at selected sites.
    For subjects who agree to participate in the Proteomics, Metabolomics, and Gene expression substudy, blood samples will be collected at randomization and at end of study. Comparing
    treatment responses and treatment-related change in proteomics, metabolomics, and gene expression may reveal important information with regard to: 1) the pathophysiology and natural history of PAH, 2) treatment response and effect of treatment on proteomics, and 3) ralinepag mechanism of action.
    E.3Principal inclusion criteria
    Each subject must meet ALL of the following inclusion criteria to be eligible for enrollment into the study:
    1. Males or females aged 18-75 years, inclusive.
    2. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures.
    3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    4. Diagnosis of symptomatic WHO Group 1 PAH classified by one of the following subgroups:
    a. Idiopathic pulmonary arterial hypertension (IPAH);
    b. Heritable pulmonary arterial hypertension (HPAH);
    c. Drugs and toxins induced based on prior exposure to legal drugs, chemicals, and toxins, such as fenfluramine derivatives, other anorexigens, toxic rapeseed oil, or L-tryptophan. A subject with PAH associated with illegal drug use, such as methamphetamine, may be included if the subject has been abstinent and under the care of the investigator for at least 1 year immediately before Screening, with at least 2 negative urine drug screening examinations performed and
    available for review by the medical monitor; and, in the investigator’s opinion, is compliant with his or her current medication regimen and overall PAH care.
    d. PAH associated with: Connective tissue disease (CTD), Human immunodeficiency virus (HIV) infection, Congenital systemic-pulmonary shunt (must have undergone surgical correction at least 1 year prior to Screening).
    5. Has had a right heart catheterization (RHC) performed at or within 365 days of Screening (RHC will be performed during Screening if not available) that is consistent with the diagnosis of PAH, meeting all of the following criteria:
    a. Mean pulmonary arterial pressure (mPAP) ≥25 mmHg (at rest)
    b. Pulmonary capillary wedge pressure (PCWP) of <15mm Hg [If PCWP is not available, then left ventricular end diastolic pressure (LVEDP) ≤15 mmHg]
    c. PVR >3.00 Wood units or >240 dynes/sec/cm5.
    If more than one RHC was performed in the last 365 days prior to Screening, the most recent RHC that includes parameters sufficient to evaluate the above criteria must be used for this assessment.
    6. Has WHO/NYHA functional class II to IV symptoms.
    7. If on PAH-specific background therapy, subject is on stable therapy with either an endothelin receptor antagonist (ERA) and/or an agent acting on the nitric oxide (NO) pathway, a phosphodiesterase type 5 (PDE5) inhibitor or a soluble guanylate cyclase (sGC) stimulator. Subjects may be naïve to PAH-specific treatments, however, subjects will still have access to locally available standard of care treatment in accordance with national guidelines.
    a. Stable is defined as no change in dose or regimen within 90 days of Screening and for the duration of the study.
    b. Subjects may be on 1 agent active in the NO pathway, i.e., either a PDE5 inhibitor or an sGC at stable dose (but not both).
    c. If the subject's disease-specific PAH therapy does not include a PDE5 inhibitor, the use of PDE5i as needed for erectile dysfunction (ED) is permitted as long as the subject has not taken a dose within 48-hours of any Baseline or study related efficacy assessment. In addition, the
    subject must not take more than 8 sildenafil tablets, 6 vardenafil, or 4 tadalafil tablets per month for ED.
    8. Has a 6MWD of ≥50 meters on two consecutive tests, within 15% of each other, preferably performed on different days during Screening.
    9. If the subject is taking the following concomitant medications that may affect PAH, the subject must be on a stable dose for at least 30 days prior to the start of Screening and the dosage maintained throughout the study.
    a. Calcium channel blockers, digoxin, or L-arginine supplementation;
    b. If the subject is taking anticoagulants, anticoagulation status must be maintained/stable in the therapeutic range for at least 30 days prior to the start of Screening. For other criteria see the protocol.
    E.4Principal exclusion criteria
    Subjects must not meet ANY of the following exclusion criteria to be eligible for enrollment into the study, unless otherwise indicated:
    1. Body weight <40 kg.
    2. Body mass index (BMI) ≥40 kg/m2.
    3. Group 2 to 5 pulmonary hypertension according to the Nice classification [Simonneau, 2013].
    4. PAH diagnosis ≥5 years at Screening.
    5. For subjects with HIV-associated PAH, any of the following:
    concomitant active opportunistic infections within 180 days of Screening, detectable viral load at Screening, cluster designation 4 (CD4+) T-cell count <200/mm3 within 90 days of Screening, changes in antiretroviral regimen within 90 days of Screening.
    6. Presence of 3 or more of the following risk factors for heart failure with preserved ejection fraction at Screening:
    a. BMI >30 kg/m2.
    b. Diabetes mellitus of any type.
    c. Essential hypertension.
    d. Significant coronary artery disease, i.e., any of the following: Angina, More than 50% stenosis in a coronary artery (by coronary angiography), Previous myocardial infarction, Previous or planned coronary artery bypass grafting and/or coronary artery stenting
    e. Left atrial volume index (LAVi) >30 mL/m2.
    7. ECHO within 365 days prior to Screening demonstrating significant left-sided heart disease, including any of the following: Left ventricular ejection fraction (LVEF) <40%, LVEF ≥50% but with impaired left ventricular (LV) relaxation. If more than one ECHO was performed in the last 365 days prior to Screening, the most recent ECHO that includes parameters sufficient to evaluate the above criteria must be used for this assessment.
    8. Has a cardiac index (CI) of >3.2 L/min/m2 obtained from a RHC performed at or within 365 days of Screening.
    9. Acutely decompensated heart failure within 30 days prior to Screening.
    10. Evidence of protocol-defined significant cardiac disease history including, but not limited to: a/ Restrictive, dilated or obstructive cardiomyopathy b/ Percutaneous coronary intervention or coronary artery bypass surgery within 180 days prior to Screening c/ Any persistent (chronic) or permanent atrial fibrillation.
    11. Has evidence of more than mild parenchymal lung disease on PFTs performed within 180 days prior to Screening. PFTs will be performed as part of Screening procedures, if data within 180 days of Screening are not available. Subjects with any of the following criteria will be excluded:
    a. Forced expiratory volume in 1 second (FEV1) <60% (predicted) (prebronchodilators);
    or
    b. Forced expiratory volume in 1 second/forced vital capacity ratio (FEV1/FVC) <65% (pre-bronchodilators); or
    c. Total lung capacity (TLC) <70% predicted. If the TLC is >60% predicted and <70% predicted, then imaging (i.e., high resolution computed tomography [HRCT]) is required to exclude parenchymal lung disease. The subject may be enrolled pending review and approval by the medical monitor.
    For criteria 12 to 34 see protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time (in days) from randomization to the first adjudicated protocol-defined clinical failure event. Subjects without a protocol-defined clinical failure event will be censored at date of last contact, 7 days after last study dose, interim analysis data cut date, or end of study date, whichever is the earliest.
    E.5.1.1Timepoint(s) of evaluation of this end point
    throughout the study
    E.5.2Secondary end point(s)
    • NT-proBNP will be analyzed using MMRM analysis with treatment, the stratification factors, week, and treatment-by-week interaction as factors and baseline NT-proBNP as a covariate. Least squares means, standard errors (SE), and 95% CIs for the treatments and their difference will be presented together with the p-value.
    • 6MWD will be analyzed using MMRM analysis with treatment, the stratification factors (less 6MWD stratum), week, and treatment-by-week interaction as factors and baseline 6MWD as a covariate. Least squares means, SEs, and 95% CIs for the treatments and their difference will be presented together with the p-value.
    • WHO/NYHA functional class will be analyzed using using CMH method adjusted for baseline WHO/NYHA functional class and using modified ridit scores to compute the test statistic and p-value for the between treatment comparison.
    • Time to all-cause hospitalization will be analyzed using Cox regression with a model that includes treatment and the stratification factors. The hazard ratio for treatment together with its 95% CI and p-value will be presented.
    • Time to all-cause mortality will be analyzed using Cox regression with a model that includes treatment and the stratification factors. The hazard ratio for treatment together with its 95% CI and p-value will be presented.
    • HRR following completion of 6MWT will be analyzed using MMRM analysis with treatment, the stratification factors, week, and treatment-by-week interaction as factors and baseline HRR as a covariate. Least squares means, SEs, and 95% CIs for the treatments and their difference will be presented together with the p-value.
    • The proportion of subjects who achieve all three of the following: NT-proBNP <300 pg/mL, 6MWD >440 meters, WHO/NYHA functional class II status or better will be analyzed using CMH method. The odds ratio will be presented together with 95% CIs and the p-value.
    • HRQoL measures will be analyzed using MMRM analysis with treatment, the stratification factors, week, and treatment-by-week interaction as factors and baseline domain score as a covariate. Least squares means, SEs, and 95% CIs for the treatments and their difference will be presented together with the p-value.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study; secondary endpoints will be assessed as the change from baseline to Week 28, except for time to all-cause hospitalization and time to all-cause mortality.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Proteomics, Metabolomics, and Gene Expression
    Cardiac Magnetic Resonance Imaging (cMRI)
    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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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
    Brazil
    Canada
    Chile
    China
    European Union
    Israel
    Japan
    Korea, Republic of
    Mexico
    Serbia
    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
    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 months4
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days13
    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: 560
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 235
    F.4.2.2In the whole clinical trial 700
    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)
    Subjects who experience a primary endpoint event at any time during the study and all subjects on IMP at the conclusion of the study (after the target number of events is achieved) will have the option to enroll in an open-label extension (OLE) study and receive treatment with ralinepag. Subjects who do not choose to participate in the OLE will discontinue IMP and may receive standard-of-care PAH treatment off-study, at the discretion of the treating physician.
    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 Decision2018-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-16
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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