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    Summary
    EudraCT Number:2017-004393-33
    Sponsor's Protocol Code Number:ID-080A301-Precision
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-15
    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 number2017-004393-33
    A.3Full title of the trial
    Multi-center, blinded, randomized, parallel-group, phase 3 study with aprocitentan in subjects with resistant hypertension (RHT).
    Studio multicentrico, in cieco, randomizzato, a gruppi paralleli, di fase 3 con aprocitentan in soggetti con ipertensione resistente (RHT).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to find out if aprocitentan is efficacious and safe to treat difficult to control (resistant) high blood pressure (hypertension).
    Uno studio di ricerca per sapere se l'aprocitentan è efficace e sicuro nel trattamento della pressione sanguigna elevata difficile da controllare (resistente).
    A.3.2Name or abbreviated title of the trial where available
    PRECISION
    PRECISION
    A.4.1Sponsor's protocol code numberID-080A301-Precision
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03541174
    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 SponsorIDORSIA 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 supportIdorsia Pharmaceuticals Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIdorsia Pharmaceuticals Ltd
    B.5.2Functional name of contact pointClinical Trial Disclosure Desk
    B.5.3 Address:
    B.5.3.1Street AddressHegenheimermattweg 91
    B.5.3.2Town/ cityAllschwil
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41588440000
    B.5.5Fax number+41588440000
    B.5.6E-mailclinical-trials-disclosure@idorsia.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 nameAprocitentan
    D.3.2Product code [ACT-132577]
    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 INNAprocitentan
    D.3.9.2Current sponsor codeACT-132577
    D.3.9.4EV Substance CodeSUB191068
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 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 nameAprocitentan
    D.3.2Product code [ACT-132577]
    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 INNAprocitentan
    D.3.9.2Current sponsor codeACT-132577
    D.3.9.3Other descriptive nameACT-132577
    D.3.9.4EV Substance CodeSUB191068
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Resistant hypertension.
    Ipertensione refrattaria.
    E.1.1.1Medical condition in easily understood language
    Difficult to control high blood pressure despite treatment with at least 3 other anti-hypertensive medications
    Ipertensione difficile da controllare nonostante un trattamento con almeno 3 differenti farmaci antiipertensivi.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10020783
    E.1.2Term Hypertension not adequately controlled
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the blood pressure (BP) lowering effect of aprocitentan when added to standard of care in true resistant hypertension (RHT) subjects.
    L’obiettivo primario dello studio è dimostrare l’effetto di aprocitentan sull’ abbassamento della pressione arteriosa (BP) quando viene aggiunto allo standard di cura nel trattamento di soggetti con vera ipertensione resistente (RHT).
    E.2.2Secondary objectives of the trial
    1) To demonstrate that the effect of aprocitentan on BP is durable when added to standard of care in true RHT subjects; 2) To evaluate the long-term safety and tolerability of aprocitentan in true RHT subjects during 48 weeks of treatment.
    Gli obiettivi secondari dello studio sono: 1) dimostrare che l’effetto di aprocitentan nella pressione arteriosa è durevole quando viene aggiunto allo standard di cura in soggetti con RHT; 2) valutare la sicurezza e la tollerabilità a lungo termine di aprocitentan in soggetti con vera RHT durante le 48 settimane di trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The main criteria per study period are:

    SCREENING CRITERIA
    This study will enroll adult male and female subjects > 18 years old with RHT defined as: a) mean sitting systolic BP ( SiSBP) = 140 m mHg measured by unattended automated office blood pressure measurement (AOBPM) despite a background antihypertensive medication of at least 3 different pharmacological classes (including a diuretic) for at least 4 weeks before the screening visit (Visit 1). Beta-blockers are not counted as background antihypertensive medication.

    RI ENTRY CRITERIA
    Subjects with a confirmed diagnosis of RHT who are on standardized background antihypertensive therapy for at least 4 weeks will enter the placebo RI period if their mean trough SiS BP is = 140 mmHg as measured by AOBPM.

    RANDOMIZATION CRITERIA
    Subjects who completed the RI period without changing the dose of the standardized background antihypertensive therapy and who have a mean trough SiS BP = 140 mmHg as measured by AOBPM will be randomized.
    I criteri principali relativi a ciascun periodo dello studio sono.

    CRITERI DI SCREENING
    In questo studio si arruoleranno soggetti adulti maschi e femmine, di età > 18 anni con RHT definita come segue: a) pressione arteriosa sistolica media da seduti (SiSBP) = 140 m mHg valutata tramite auto-misurazione automatica della pressione arteriosa nello studio medico (AOBPM) nonostante la somministrazione di una terapia antipertensiva di base costituita da 3 diverse classi farmacologiche (incluso un diuretico) per almeno 4 settimane prima della visita di screening (Visita 1). I beta bloccanti non vengono considerati come farmaci per la terapia antipertensiva di base.

    CRITERI DI INGRESSO RI
    I soggetti con una diagnosi confermata di RHT che stanno assumendo una terapia antipertensiva di base da almeno 4 settimane entreranno nel periodo placebo RI se la loro SiSBP media pre-dose è = 140 mmHg misurata tramite AOBPM.

    CRITERI DI RANDOMIZZAZIONE
    I soggetti che hanno completato il periodo RI senza cambiamenti della terapia di base antipertensiva che hanno la SiSBP media pre-dose = 140 mmHg misurata con AOBPM saranno randomizzati.
    E.4Principal exclusion criteria
    The main exclusion criteria are: a) apparent / pseudo RHT due to white coat effect, medical inertia, poor therapeutic adherence, or secondary causes of
    hypertension (except sleep apnea); b) Confirmed severe hypertension (grade 3): mean SiS BP = 180 mmHg and/or sitting diastolic blood pressure
    (SiDBP) = 110 mmHg, measured by AOBPM at two different time points.- Pregnant or lactating subjects;
    - Clinically significant unstable cardiac disease in the opinion of the
    investigator;
    - Severe renal insufficiency;
    - N-terminal pro-brain natriuretic peptide (NT-proBNP) = 500 pg/mL;
    - Any known factor, disease or clinically relevant medical or surgical conditions that, in the opinion of the investigator, might put the subject at risk, interfere with treatment compliance, study conduct or interpretation of the results
    I principali criteri di esclusione sono: a) RHT apparente / pseudo a causa dell'effetto camice bianco, inerzia medica,scarsa aderenza terapeutica o cause secondarie di ipertensione (tranne apnea notturna); b) Ipertensione grave confermata (grado 3): SiSBP media = 180 mmHg e/o pressione diastolica da seduti (SiDBP)media = 110 mmHg, misurata tramite AOBPM a due diversi punti temporali.

    - Soggetti in gravidanza o in allattamento;
    - Malattia cardiaca instabile clinicamente significativa secondo il parere dello sperimentatore;
    - Insufficienza renale grave;
    - Peptide natriuretico pro-BNP (NT-proBNP) = 500 pg / mL;
    - Qualsiasi fattore, malattia o condizione clinica o chirurgica nota clinicamente rilevante che, secondo il parere dello sperimentatore, potrebbero mettere il soggetto
    a rischio, interferire con la compliance del trattamento, la conduzione dello studio o l' interpretazione dei risultati
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change from baseline to Week 4 of DB treatment in mean trough SiSBP measured by AOBPM.
    L'endpoint di efficacia primario è il cambiamento dal basale alla Settimana 4 del trattamento DB nella SiSBP media pre-dose misurata tramite AOBPM.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4 of DB treatment
    Settimana 4 del trattamento DB
    E.5.2Secondary end point(s)
    The key secondary endpoint is the change from Week 36 (i.e., start of DB-WD) to Week 40 in mean trough SiSBP measured by AOBPM.
    The other secondary efficacy endpoints are:
    • Change from baseline to Week 4 of DB treatment in mean trough SiDBP measured by AOBPM;
    • Changes from baseline to Week 4 of DB treatment in 24 h mean systolic BP (SBP) and diastolic BP (DBP) measured by ambulatory blood pressure monitoring (ABPM);
    • Change from Week 36 to Week 40 of DB-WD treatment in mean trough SiDBP measured by AOBPM;
    • Changes from Week 36 to Week 40 of DB-WD treatment in 24 h mean SBP and DBP measured by ABPM.; Main safety endpoints
    • Treatment-emergent adverse events (AEs);
    • Treatment-emergent serious AEs;
    • Treatment-emergent AEs leading to premature discontinuation of study treatment;
    • Treatment-emergent major adverse cardiac events (MACE), defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke; only those events confirmed by Central Adjudication Committee (CAC) will be considered;
    • Treatment-emergent MACE-plus, defined as cardiovascular death, non-fatal MI, non-fatal stroke and hospitalization for heart failure; only those events confirmed by CAC will be considered;
    • Increase of the dose of an existing diuretic or addition of a new diuretic due to fluid retention;
    • Any AEs/abnormalities temporally associated with the use of study treatment (from RI placebo initiation until 30 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.; Pharmacokinetic endpoints
    • Trough plasma concentration of aprocitentan at Week 4 of the DB part.
    L'endpoint secondario principale è il cambiamento dalla Settimana 36 (cioè, inizio della fase DB-WD) alla Settimana 40 della SiSBP media pre-dose misurata tramite AOBPM. Gli altri endpoint secondari di efficacia sono:
    • Cambiamenti dal basale alla Settimana 4 del trattamento DB della SiDBP media pre-dose misurata tramite AOBPM;
    • Cambiamenti dal basale alla Settimana 4 del trattamento DB nelle 24 h della pressione arteriosa sistolica (SBP) e diastolica (DBP) misurate tramite monitoraggio ambulatorio della pressione arteriosa (ABPM);
    • Cambiamenti dalla Settimana 36 alla Settimana 40 del trattamento DB-WD della SiDBP media pre-dose misurata con AOBPM;
    • Cambiamenti dalla Settimana 36 alla Settimana 40 del trattamento DB-WD nelle 24 ore della SBP e DBP medie misurate con ABPM. ; Principali endpoint di sicurezza
    • Eventi avversi emergenti dal trattamento1 (AEs);
    • Eventi avversi emergenti dal trattamento seri;
    • Eventi avversi emergenti dal trattamento che portano all'interruzione prematura del trattamento di studio;
    • Eventi avversi emergenti dal trattamento maggiori (MACE),definiti come morte cardiovascolare, infarto miocardico non fatale(MI) e ictus non fatale; solo quegli eventi confermati dal Central Adjudication Committee (CAC) saranno presi in considerazione;
    • Eventi avversi emergenti dal trattamento maggiori MACE-plus, definiti come morte cardiovascolare, infarto miocardico non mortale, ictus non fatale e ospedalizzazione per scompenso cardiaco; saranno presi in considerazione solo gli eventi confermati dal CAC;
    • Aumento della dose di un diuretico esistente o aggiunta di un nuovo diuretico a causa di ritenzione di fluidi;
    • Qualsiasi AE/anomalia associata temporalmente all'uso dello trattamento sperimentale (dall'inizio del periodo placebo-RI a 30 giorni dopo l’ interruzione del trattamento sperimentale) indipendentemente dal fatto che siano stati o meno considerati in relazione al trattamento sperimentale dallo sperimentatore.
    ; Endpoint farmacocinetici
    • Concentrazione plasmatica pre-dose di aprocitentan alla Settimana 4 della fase in doppio cieco DB.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to Week 4 and from Week 36 (i.e., start of DB-WD) to Week 40.; Entire duration of treatment; Week 4 of the DB part.
    Dal basale alla Settimana 4 del trattamento DB e dalla Settimana 36 (cioè, inizio della fase DB-WD) alla Settimana 40.; Intera durata del trattamento.; Settimana della fase in doppio cieco.
    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 Yes
    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 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Run-in vs. placebo in singolo cieco seguito da una fase randomizzata in doppio / singolo cieco
    SB placebo run/in & randomized with 3 parts: (DB), (SB) and (DB/WD)
    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 trial6
    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 concerned6
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Canada
    China
    Czechia
    Denmark
    Finland
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Netherlands
    Norway
    Poland
    Romania
    Russian Federation
    Spain
    Sweden
    Switzerland
    United Kingdom
    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
    End of the trial is defined as last subject last visit (LSLV).
    La fine dello studio è definita dall'ultima visita dell'ultimo paziente (LSLV).
    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 months33
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months33
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 600
    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)
    After the subject's study completion or premature withdrawal from the study, whichever applies, the investigator/delegate will explain to
    subjects what treatment(s) / medical care is necessary and available according to local regulations.
    Dopo il completamento del soggetto in studio o la sua prematura uscita dallo studio, nella prima delle due evenienze, lo sperimentatore o il suo delegato spiegheranno al soggetto quali trattamenti / cure mediche sono necessarie e disponibili secondo la normativa locale.
    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 Decision2018-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-11
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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