Clinical trial • Phase II • Cardiology
JTT-861 MONOHYDROCHLORIDE DIHYDRATE for Heart failure with reduced ejection fraction
Phase II trial of JTT-861 MONOHYDROCHLORIDE DIHYDRATE for Heart failure with reduced ejection fraction.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Heart failure with reduced ejection fraction
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 13-10-2023
- First CTIS Authorization Date
- 12-02-2024
Trial design
Randomised, jtt-861 50 mg once daily (qd) for 12 weeks; jtt-861 100 mg once daily (qd) for 12 weeks; placebo once daily (qd) for 12 weeks.-controlled Phase II trial across 60 sites in Spain, Czechia, Romania and others.
- Randomised
- Yes
- Comparator
- JTT-861 50 mg once daily (QD) for 12 weeks; JTT-861 100 mg once daily (QD) for 12 weeks; Placebo once daily (QD) for 12 weeks.
- Target Sample Size
- 300
- Trial Duration For Participant
- 112
Eligibility
Recruits 300 Vulnerable population selected. Subject information and informed consent forms are provided (e.g. L1_* SIS-ICF_Main and language-specific SIS-ICF documents including Polish, Spanish, Czech, Romanian, Bulgarian versions, and an Adult-Parent ICF listed for Poland). The record does not provide a detailed description of assent procedures or explicit consent/assent handling text beyond the availability of these informed consent documents..
- Vulnerable Population
- Vulnerable population selected. Subject information and informed consent forms are provided (e.g. L1_* SIS-ICF_Main and language-specific SIS-ICF documents including Polish, Spanish, Czech, Romanian, Bulgarian versions, and an Adult-Parent ICF listed for Poland). The record does not provide a detailed description of assent procedures or explicit consent/assent handling text beyond the availability of these informed consent documents.
Inclusion criteria
- {"criterion_text":"- Male or female, age 30-85 years (inclusive), at the Screening Visit;\n- Has a clinical diagnosis of symptomatic heart failure (HF) ≥90 days prior to the Screening Visit;\n- Is in New York Heart Association (NYHA) functional class II or III at the Screening Visit;\n- Is on stable, guideline-directed therapy for HF, consistent with American Heart Association (AHA), American College of Cardiology (ACC), Heart Failure Society of America (HFSA) or European Society of Cardiology (ESC) guidelines for ≥4 weeks prior to the Screening Visit (with at least half of maximal labeled dose of renin-angiotensin-aldosterone system (RAAS) inhibitors and β-blockers, if tolerated);\n- Has left ventricular ejection fraction (LVEF) ≤35% at the Screening Visit;\n- Has a serum N-terminal pro b-type natriuretic peptide (NT-pro-BNP) level ≥600 pg/mL (or ≥900 pg/mL if the subject has atrial fibrillation or atrial flutter) at the Screening Visit; Note: In the context of paced rhythm, the underlying cardiac rhythm should be considered when selecting the NT-pro-BNP cutoff level."}
Exclusion criteria
- {"criterion_text":"- Has a confirmed acute myocardial infarction (MI) (i.e., Type 1) or unstable angina within 90 days prior to the Screening Visit;\n- Has a history of coronary revascularization (percutaneous coronary intervention [PCI] and/or coronary artery bypass graft [CABG]) or other cardiovascular surgery within 90 days prior to the Screening Visit or planned cardiovascular surgery during the study through the Follow-up Visit);\n- Has started cardiac resynchronization therapy (CRT) within 90 days prior to the Screening Visit or has planned CRT during the study through the Follow-up Visit;\n- Has clinically significant congenital heart disease, active myocarditis or constrictive pericarditis;\n- Has current acute worsening HF requiring additional treatment with diuretics, vasodilators and/or inotropic medications at the Screening Visit;\n- Has clinically significant chronic renal insufficiency (i.e., estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine equation) at the Screening Visit."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Efficacy Parameters • Change from baseline to end of treatment (EOT) in: o LVEF as assessed by two-dimensional echocardiography (2D-echo) o Left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo o Left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo","definition_or_measurement_approach":"Change from baseline to EOT in LVEF, LVESV index and LVEDV index as assessed by two-dimensional echocardiography (2D-echo)."}
- {"endpoint_text":"- Efficacy Parameters • Change from baseline to end of treatment (EOT) in: o Left atrial volume (LAV) as assessed by 2D-echo o NT-pro-BNP o Kansas City Cardiomyopathy Questionnaire (KCCQ) scores","definition_or_measurement_approach":"Change from baseline to EOT in LAV assessed by 2D-echo, change in NT-pro-BNP concentration, and change in KCCQ scores."}
- {"endpoint_text":"- Pharmacokinetic (PK) Parameters • JTT-861 trough plasma concentrations at Weeks 4, 8 and 12 • JTT-861 plasma concentrations (post-dose) at Weeks 2, 4 and 8","definition_or_measurement_approach":"PK: measurement of JTT-861 plasma concentrations (trough at Weeks 4, 8, 12; post-dose at Weeks 2, 4, 8) by plasma assays."}
- {"endpoint_text":"- Safety Parameters • Number of subjects with adverse events (AEs), change from baseline in safety laboratory, vital signs and 12-lead electrocardiogram (ECG) parameters.","definition_or_measurement_approach":"Safety assessments include counts of subjects with AEs, laboratory safety parameter changes from baseline, vital signs, and 12-lead ECG parameter changes."}
Secondary endpoints
- {"endpoint_text":"- Exploratory Efficacy Parameters • Change from baseline to EOT in: o eGFR o Cystatin C o Urine albumin-to-creatinine ratio (ACR) o Hemoglobin A1c (HbA1c) and plasma glucose","definition_or_measurement_approach":"Change from baseline to EOT in renal and metabolic biomarkers: eGFR (CKD-EPI), cystatin C, urine ACR, HbA1c and plasma glucose (laboratory assays)."}
- {"endpoint_text":"- Exploratory Efficacy Parameters • Change from baseline to EOT in: o Tricuspid annular plane systolic excursion (TAPSE) as assessed by 2D-echo o Fractional area change (FAC) as assessed by 2D-echo o Right ventricular (RV) longitudinal strain as assessed by 2D-echo o Tricuspid regurgitation peak gradient (TRPG) as assessed by 2D-echo","definition_or_measurement_approach":"Change from baseline to EOT in RV function measures (TAPSE, FAC, RV longitudinal strain, TRPG) assessed by 2D-echocardiography."}
- {"endpoint_text":"- Exploratory Pharmacodynamic (PD) Parameters • Change from baseline to EOT in branched-chain amino acids (BCAAs: isoleucine, leucine and valine) and alanine plasma concentrations","definition_or_measurement_approach":"Change from baseline to EOT in plasma concentrations of BCAAs (isoleucine, leucine, valine) and alanine measured by plasma assays."}
Recruitment
- Planned Sample Size
- 300
- Recruitment Window Months
- 36
- Consent Approach
- Informed consent to be obtained using subject information and informed consent forms (SIS-ICF) provided in multiple languages (documents listed in Spanish, Czech, Romanian, Bulgarian, Polish). Country-specific SIS-ICF_Main and SIS-ICF_Pregnancy/Pregnancy Data Collection forms are available; a Polish 'Adult-Parent ICF' is listed. The record does not detail assent procedures; consent is obtained from the participant via the provided ICF documents in the participant's language.
Methods
- Patient letters (country-specific patient letters listed for Spain, Czechia, Romania, Bulgaria, Poland) — channel: mailed/clinic-distributed patient letter; target audience: potential patient-participants.
- HCP letters (country-specific HCP letters for Spain, Czechia, Romania, Bulgaria, Poland) — channel: letters to healthcare professionals; target audience: treating clinicians/referral sources.
- Flyers and brochures (multiple language versions per country) — channel: printed materials/clinic distribution; target audience: patients and caregivers.
- Appointment reminder cards and patient diary materials — channel: study site handouts; target audience: enrolled participants.
- IP carton stickers and IP dosing magnets — channel: study product labeling at sites; target audience: participants receiving study drug (country-specific versions present).
- Study presentations, factsheets, flipbooks, study visit guides and study assistance items — channel: site-provided materials and HCP engagement; target audience: patients and site staff.
- Materials and recruitment procedures are country-specific with dedicated K1 (Recruitment Procedure) and K2 (Recruitment Material) documents for Spain (ES), Czechia (CZ), Romania (RO), Bulgaria (BG) and Poland (PL).
Geography
- Total Number Of Sites
- 60
- Total Number Of Participants
- 422
Spain
- Earliest CTIS Part Ii Submission Date
- 19-01-2024
- Latest Decision Or Authorization Date
- 07-04-2025
- Processing Time Days
- 444
- Number Of Sites
- 13
- Number Of Participants
- 41
Sites
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Cardiology
- Principal Investigator Name
- José Ramón González Juanatey
- Principal Investigator Email
- Jose.ramon.gonzalez.juanatey@sergas.es
- Contact Person Name
- José Ramón González Juanatey
- Contact Person Email
- Jose.ramon.gonzalez.juanatey@sergas.es
- Site Name
- Area Sanitaria De Ferrol
- Department Name
- Cardiology
- Principal Investigator Name
- Francisco Martinez Deben
- Principal Investigator Email
- francisco.martinez.deben@sergas.es
- Contact Person Name
- Francisco Martinez Deben
- Contact Person Email
- francisco.martinez.deben@sergas.es
- Site Name
- Hospital Del Mar
- Department Name
- Cardiology
- Principal Investigator Name
- Sonia Ruiz Bustillo
- Principal Investigator Email
- sruiz@psmar.cat
- Contact Person Name
- Sonia Ruiz Bustillo
- Contact Person Email
- sruiz@psmar.cat
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Cardiology
- Principal Investigator Name
- Pablo Garcia Pavia
- Principal Investigator Email
- pablogpavia@yahoo.es
- Contact Person Name
- Pablo Garcia Pavia
- Contact Person Email
- pablogpavia@yahoo.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Cardiology
- Principal Investigator Name
- Luis Almenar Bonet
- Principal Investigator Email
- lualmenar@gmail.com
- Contact Person Name
- Luis Almenar Bonet
- Contact Person Email
- lualmenar@gmail.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Cardiology
- Principal Investigator Name
- Julio Nuñez de Villota
- Principal Investigator Email
- yulnunez@gmail.com
- Contact Person Name
- Julio Nuñez de Villota
- Contact Person Email
- yulnunez@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Cardiology
- Principal Investigator Name
- Jesús Álvarez García
- Principal Investigator Email
- jalvarezg82@gmail.com
- Contact Person Name
- Jesús Álvarez García
- Contact Person Email
- jalvarezg82@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Cardiology
- Principal Investigator Name
- Juan José Gómez Doblás
- Principal Investigator Email
- jjgomezdoblas@gmail.com
- Contact Person Name
- Juan José Gómez Doblás
- Contact Person Email
- jjgomezdoblas@gmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Cardiology
- Principal Investigator Name
- Domingo Pascual Figal
- Principal Investigator Email
- dpascual@um.es
- Contact Person Name
- Domingo Pascual Figal
- Contact Person Email
- dpascual@um.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Cardiology
- Principal Investigator Name
- Rafael Hidalgo Urbano
- Principal Investigator Email
- rjhidalur@yahoo.es
- Contact Person Name
- Rafael Hidalgo Urbano
- Contact Person Email
- rjhidalur@yahoo.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Cardiology
- Principal Investigator Name
- Jose Raul Moreno Gomez
- Principal Investigator Email
- raulmorenog@hotmail.com
- Contact Person Name
- Jose Raul Moreno Gomez
- Contact Person Email
- raulmorenog@hotmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Cardiology
- Principal Investigator Name
- Manuel Martinez-Selles d'Oliveira Soares
- Principal Investigator Email
- mmselles@secardiologia.es
- Contact Person Name
- Manuel Martinez-Selles d'Oliveira Soares
- Contact Person Email
- mmselles@secardiologia.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Cardiology
- Principal Investigator Name
- Mikel Taibo Urquia
- Principal Investigator Email
- mikel.taibo@quironsalud.es
- Contact Person Name
- Mikel Taibo Urquia
- Contact Person Email
- mikel.taibo@quironsalud.es
Czechia
- Earliest CTIS Part Ii Submission Date
- 19-01-2024
- Latest Decision Or Authorization Date
- 03-04-2025
- Processing Time Days
- 440
- Number Of Sites
- 11
- Number Of Participants
- 56
Sites
- Site Name
- Medicus Services s.r.o.
- Department Name
- Kardiologická ambulance MUDr. Jiřího Krupičky, Ph.D.
- Principal Investigator Name
- Jiří Krupička
- Principal Investigator Email
- Kardiologie.brandys@seznam.cz
- Contact Person Name
- Jiří Krupička
- Contact Person Email
- Kardiologie.brandys@seznam.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Interní a kardiologická klinika
- Principal Investigator Name
- Jan Václavík
- Principal Investigator Email
- jan.vaclavik@fno.cz
- Contact Person Name
- Jan Václavík
- Contact Person Email
- jan.vaclavik@fno.cz
- Site Name
- MUDr. Libor Nechvatal s.r.o.
- Department Name
- Kardiologická ambulance Hybešova
- Principal Investigator Name
- Libor Nechvátal
- Principal Investigator Email
- linechvatal@seznam.cz
- Contact Person Name
- Libor Nechvátal
- Contact Person Email
- linechvatal@seznam.cz
- Site Name
- Edumed s.r.o.
- Department Name
- Kardiologická ambulance Broumov
- Principal Investigator Name
- Veronika Krbcová Moudra
- Principal Investigator Email
- veronika.krbcova@edu-med.cz
- Contact Person Name
- Veronika Krbcová Moudra
- Contact Person Email
- veronika.krbcova@edu-med.cz
- Site Name
- Edumed s.r.o.
- Department Name
- Kardiologická ambulance Hradec Králové
- Principal Investigator Name
- Terézia Švarcová
- Principal Investigator Email
- tereza.svarcova@edu-med.cz
- Contact Person Name
- Terézia Švarcová
- Contact Person Email
- tereza.svarcova@edu-med.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Interní kardiologická klinika
- Principal Investigator Name
- Petr Kala
- Principal Investigator Email
- Kala.Petr@fnbrno.cz
- Contact Person Name
- Petr Kala
- Contact Person Email
- Kala.Petr@fnbrno.cz
- Site Name
- Centrum pro zdravi s.r.o.
- Principal Investigator Name
- Martin Plachý
- Principal Investigator Email
- 78martin.plachy@gmail.com
- Contact Person Name
- Martin Plachý
- Contact Person Email
- 78martin.plachy@gmail.com
- Site Name
- Fakultni Nemocnice U Sv Anny V Brne
- Department Name
- II. interní klinika
- Principal Investigator Name
- Robert Prosecký
- Principal Investigator Email
- robert.prosecky@fnusa.cz
- Contact Person Name
- Robert Prosecký
- Contact Person Email
- robert.prosecky@fnusa.cz
- Site Name
- Edumed s.r.o.
- Department Name
- Kardiologická ambulance Jaroměř
- Principal Investigator Name
- Jiří Veselý
- Principal Investigator Email
- vesely.edumed@gmail.com
- Contact Person Name
- Jiří Veselý
- Contact Person Email
- vesely.edumed@gmail.com
- Site Name
- Vojenska Nemocnice Brno
- Department Name
- Interní ambulance - kardiologie
- Principal Investigator Name
- Roman Miklík
- Principal Investigator Email
- romanmiklik@yahoo.com
- Contact Person Name
- Roman Miklík
- Contact Person Email
- romanmiklik@yahoo.com
- Site Name
- Edumed s.r.o.
- Department Name
- Kardiologická ambulance
- Principal Investigator Name
- Miroslava Polášková
- Principal Investigator Email
- Miroslava.polaskova@edu-med.cz
- Contact Person Name
- Miroslava Polášková
- Contact Person Email
- Miroslava.polaskova@edu-med.cz
Romania
- Earliest CTIS Part Ii Submission Date
- 01-11-2023
- Latest Decision Or Authorization Date
- 07-07-2025
- Processing Time Days
- 614
- Number Of Sites
- 13
- Number Of Participants
- 70
Sites
- Site Name
- Spitalul Universitar De Urgenta Bucuresti
- Department Name
- Cardiology 2
- Principal Investigator Name
- Dragos Vinereanu
- Principal Investigator Email
- vinereanu@gmail.com
- Contact Person Name
- Dragos Vinereanu
- Contact Person Email
- vinereanu@gmail.com
- Site Name
- Cardio Med S.R.L.
- Department Name
- Cardiology
- Principal Investigator Name
- Constantin Militaru
- Principal Investigator Email
- cccmilitaru@yahoo.com
- Contact Person Name
- Constantin Militaru
- Contact Person Email
- cccmilitaru@yahoo.com
- Site Name
- Mat Cord Biomedica S.R.L.
- Department Name
- Cardiology
- Principal Investigator Name
- Florin Lucian Matei
- Principal Investigator Email
- dr.matei.florin@gmail.com
- Contact Person Name
- Florin Lucian Matei
- Contact Person Email
- dr.matei.florin@gmail.com
- Site Name
- Thera Card S.R.L.
- Department Name
- Cardiology
- Principal Investigator Name
- Cornelia Ancuta Zara
- Principal Investigator Email
- office@theracardia.ro
- Contact Person Name
- Cornelia Ancuta Zara
- Contact Person Email
- office@theracardia.ro
- Site Name
- Spitalul Clinic Judetean De Urgenta Craiova
- Department Name
- Cardiology
- Principal Investigator Name
- Octavian Istratoaie
- Principal Investigator Email
- Scjuc.craiova@gmail.com
- Contact Person Name
- Octavian Istratoaie
- Contact Person Email
- Scjuc.craiova@gmail.com
- Site Name
- CMI Dr. Podoleanu Cristian
- Principal Investigator Name
- Cristian Gheorghe Calin Podoleanu
- Principal Investigator Email
- podoleanu@me.com
- Contact Person Name
- Cristian Gheorghe Calin Podoleanu
- Contact Person Email
- podoleanu@me.com
- Site Name
- Spitalul Clinic De Urgenta Sf. Pantelimon Bucuresti
- Department Name
- Internal Medicine
- Principal Investigator Name
- Monica Popescu
- Principal Investigator Email
- scusfpant@yahoo.com
- Contact Person Name
- Monica Popescu
- Contact Person Email
- scusfpant@yahoo.com
- Site Name
- Angiocare S.R.L.
- Department Name
- Interventional Cardiology
- Principal Investigator Name
- Stefan Dan Cezar Mot
- Principal Investigator Email
- mihaela.somlea@centrele-ares.ro
- Contact Person Name
- Stefan Dan Cezar Mot
- Contact Person Email
- mihaela.somlea@centrele-ares.ro
- Site Name
- Spitalul Clinic Judetean De Urgenta Brasov
- Department Name
- Cardiology
- Principal Investigator Name
- Ovidiu Florin Orțan
- Principal Investigator Email
- sep.scjubv@gmail.com
- Contact Person Name
- Ovidiu Florin Orțan
- Contact Person Email
- sep.scjubv@gmail.com
- Site Name
- Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
- Department Name
- Cardiology
- Principal Investigator Name
- Sanziana Barbulescu
- Principal Investigator Email
- office@neomed.org
- Contact Person Name
- Sanziana Barbulescu
- Contact Person Email
- office@neomed.org
- Site Name
- Cardio Med S.R.L.
- Department Name
- Cardiology
- Principal Investigator Name
- Imre Sandor Benedek
- Principal Investigator Email
- imrebenedek@yahoo.com
- Contact Person Name
- Imre Sandor Benedek
- Contact Person Email
- imrebenedek@yahoo.com
- Site Name
- Spitalul Clinic Municipal De Urgenta Timisoara
- Department Name
- Cardiology Clinic-ASCAR
- Principal Investigator Name
- Minodora Andor
- Principal Investigator Email
- secretariat@smtm.ro
- Contact Person Name
- Minodora Andor
- Contact Person Email
- secretariat@smtm.ro
- Site Name
- Spitalul Clinic Municipal De Urgenta Timisoara
- Department Name
- Cardiology II
- Principal Investigator Name
- Daniel Florin Lighezan
- Principal Investigator Email
- secretariat@smtm.ro
- Contact Person Name
- Daniel Florin Lighezan
- Contact Person Email
- secretariat@smtm.ro
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 09-02-2024
- Latest Decision Or Authorization Date
- 19-08-2025
- Processing Time Days
- 557
- Number Of Sites
- 10
- Number Of Participants
- 209
Sites
- Site Name
- Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD
- Department Name
- First Clinic of Cardiology – Cardiology
- Principal Investigator Name
- Ivo Petrov
- Principal Investigator Email
- Ivo.Petrov@acibademcityclinic.bg
- Contact Person Name
- Ivo Petrov
- Contact Person Email
- Ivo.Petrov@acibademcityclinic.bg
- Site Name
- Diagnostics And Consultation Center Convex Ltd.
- Department Name
- Not applicable
- Principal Investigator Name
- Stefan Naydenov
- Principal Investigator Email
- snaydenov@gmail.com
- Contact Person Name
- Stefan Naydenov
- Contact Person Email
- snaydenov@gmail.com
- Site Name
- Multi-profile Hospital for Active Treatment Heart and Brain EAD
- Department Name
- First Department of Cardiology at the Cardiology Clinic
- Principal Investigator Name
- Iana Simova
- Principal Investigator Email
- ianasimova@gmail.com
- Contact Person Name
- Iana Simova
- Contact Person Email
- ianasimova@gmail.com
- Site Name
- ASIMPKIP D-R Elena Docheva EOOD
- Department Name
- Not applicable
- Principal Investigator Name
- Elena Dotcheva
- Principal Investigator Email
- eldotcheva@abv.bg
- Contact Person Name
- Elena Dotcheva
- Contact Person Email
- eldotcheva@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
- Department Name
- Clinic of cardiology
- Principal Investigator Name
- Konstantin Gospodinov
- Principal Investigator Email
- drkdg@abv.bg
- Contact Person Name
- Konstantin Gospodinov
- Contact Person Email
- drkdg@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Cardiology Department at the Cardiology Clinic
- Principal Investigator Name
- Fedya Nikolov
- Principal Investigator Email
- prof.fedya.nikolov@gmail.com
- Contact Person Name
- Fedya Nikolov
- Contact Person Email
- prof.fedya.nikolov@gmail.com
- Site Name
- Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
- Department Name
- Clinic of cardiology
- Principal Investigator Name
- Neli Georgieva
- Principal Investigator Email
- ngeorgieva87@gmail.com
- Contact Person Name
- Neli Georgieva
- Contact Person Email
- ngeorgieva87@gmail.com
- Site Name
- University Hospital St. Anna
- Department Name
- Department of general cardiology at the first internal diseases clinic - Cardiology
- Principal Investigator Name
- Dimitar Raev
- Principal Investigator Email
- draevbg56@yahoo.com
- Contact Person Name
- Dimitar Raev
- Contact Person Email
- draevbg56@yahoo.com
- Site Name
- Medical Center Hera EOOD
- Department Name
- Not applicable
- Principal Investigator Name
- Iskren Garvanski
- Principal Investigator Email
- iskren.garvanski@heraclinics.com
- Contact Person Name
- Iskren Garvanski
- Contact Person Email
- iskren.garvanski@heraclinics.com
- Site Name
- Multiprofile Hospital For Active Treatment Ivan Skenderov EOOD
- Department Name
- Clinic of Cardiology
- Principal Investigator Name
- Plamen Krastev
- Principal Investigator Email
- plamenkrastev82@gmail.com
- Contact Person Name
- Plamen Krastev
- Contact Person Email
- plamenkrastev82@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 18-07-2025
- Processing Time Days
- 543
- Number Of Sites
- 13
- Number Of Participants
- 46
Sites
- Site Name
- Clinmedica Research Sp. z o.o.
- Principal Investigator Name
- Grzegorz Kania
- Principal Investigator Email
- grzegorz.kania@gmail.com
- Contact Person Name
- Grzegorz Kania
- Contact Person Email
- grzegorz.kania@gmail.com
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- Klinika Kardiologii i Chorób Wewnętrznych z OINK
- Principal Investigator Name
- Agnieszka Tycinska
- Principal Investigator Email
- agnieszka.tycinska@gmail.com
- Contact Person Name
- Agnieszka Tycinska
- Contact Person Email
- agnieszka.tycinska@gmail.com
- Site Name
- Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
- Department Name
- Oddział Kardiologiczny Klinika Kardiologii Katedry Kardiologii UM w Łodzi
- Principal Investigator Name
- Radosław Kręcki
- Principal Investigator Email
- rkrecki@gmail.com
- Contact Person Name
- Radosław Kręcki
- Contact Person Email
- rkrecki@gmail.com
- Site Name
- American Heart Of Poland S.A.
- Department Name
- PAKS X Oddział Kardiologii Inwazyjnej,Elektrofizjologii i Elektrostymulacji
- Principal Investigator Name
- Adam Janas
- Principal Investigator Email
- adam.janas@ahop.pl
- Contact Person Name
- Adam Janas
- Contact Person Email
- adam.janas@ahop.pl
- Site Name
- Centrum Rehabilitacji I Kardiologii Solutaris Prokopczuk Sp. j.
- Principal Investigator Name
- Janusz Prokopczuk
- Principal Investigator Email
- drjprokopczuk@careaccess.com
- Contact Person Name
- Janusz Prokopczuk
- Contact Person Email
- drjprokopczuk@careaccess.com
- Site Name
- 4 Wojskowy Szpital Kliniczny Z Polikliniką Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
- Department Name
- Klinika Kardiologii, Ośrodek Chorób Serca
- Principal Investigator Name
- Bartosz Krakowiak
- Principal Investigator Email
- bartek.krakowiak@gmail.com
- Contact Person Name
- Bartosz Krakowiak
- Contact Person Email
- bartek.krakowiak@gmail.com
- Site Name
- Kardio Brynow Sp. z o.o.
- Principal Investigator Name
- Wojciech Wojakowski
- Principal Investigator Email
- wojtek.wojakowski@gmail.com
- Contact Person Name
- Wojciech Wojakowski
- Contact Person Email
- wojtek.wojakowski@gmail.com
- Site Name
- NZOZ „Pro Cordis” Sopockie Centrum Badań Kardiologicznych Paweł Miękus
- Principal Investigator Name
- Paweł Miękus
- Principal Investigator Email
- miekus1@wp.pl
- Contact Person Name
- Paweł Miękus
- Contact Person Email
- miekus1@wp.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
- Department Name
- Klin. Oddz. Kardiologii, Rehabil. Kardiolog., Chorób Wewn. z Pododdz. Intensywnej Opieki Kardiol.
- Principal Investigator Name
- Robert Błaszczyk
- Principal Investigator Email
- robertblaszczyk1@wp.pl
- Contact Person Name
- Robert Błaszczyk
- Contact Person Email
- robertblaszczyk1@wp.pl
- Site Name
- American Heart Of Poland S.A.
- Department Name
- MAŁOPOLSKIE CENTRUM SERCOWONACZYNIOWE PAKS Oddział Intensywnej Opieki Kardiologicznej
- Principal Investigator Name
- Aleksander Żurakowski
- Principal Investigator Email
- olekzurakowski@gmail.com
- Contact Person Name
- Aleksander Żurakowski
- Contact Person Email
- olekzurakowski@gmail.com
- Site Name
- Trialmed Sp. z o.o.
- Department Name
- TRIALMED CRS
- Principal Investigator Name
- Ewa Kalecińska-Krystkiewicz
- Principal Investigator Email
- e.krystkiewicz@gmail.com
- Contact Person Name
- Ewa Kalecińska-Krystkiewicz
- Contact Person Email
- e.krystkiewicz@gmail.com
- Site Name
- American Heart Of Poland S.A.
- Department Name
- Polsko-Amerykańskie Kliniki Serca III Oddz. Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
- Principal Investigator Name
- Katarzyna Szymczyk
- Principal Investigator Email
- katarzyna.szymczyk@ahop.pl
- Contact Person Name
- Katarzyna Szymczyk
- Contact Person Email
- katarzyna.szymczyk@ahop.pl
- Site Name
- American Heart Of Poland S.A.
- Principal Investigator Name
- Aleksander Żurakowski
- Principal Investigator Email
- olekzurakowski@gmail.com
- Contact Person Name
- Aleksander Żurakowski
- Contact Person Email
- olekzurakowski@gmail.com
Sponsor
Primary sponsor
- Full Name
- Akros Pharma Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Multiple operational responsibilities including codes 1,2,4,5,6,8,10,11,12,13,15; noted role: Site Portal and Training / Imaging
- Name
- Almac Clinical Services (Ireland) Limited / Almac Clinical Services LLC
- Responsibilities
- Distribution and packaging/labelling functions (sponsorDuties codes 14; 15 - Country Depot - Distribution; Packaging and labelling)
- Name
- Suvoda LLC
- Responsibilities
- sponsorDuties code: 3 (clinical supply / study supply related services listed)
Third parties
- {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"sponsorDuties codes: 14; 15 - Country Depot - Distribution","organisation_type":"Pharmaceutical company"}
- {"country":"Japan","full_name":"Central Pharmaceutical Research Institute (CPRI)","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Industry"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"sponsorDuties codes: 14; 15 - Packaging and labelling","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 6; 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Imperial Clinical Research Services International Limited","duties_or_roles":"sponsorDuties code: 15 - Printing Services Clinical Materials","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 1,2,4,5,6,8,10,11,12,13,15 (includes 'Site Portal and Training / Imaging')","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- JTT-861
- Active Substance
- JTT-861 MONOHYDROCHLORIDE DIHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Investigational (MIA (IMP) 20377)
- Starting Dose
- 50 mg
- Dose Levels
- 50 mg; 100 mg
- Frequency
- Once daily (QD)
- Maximum Dose
- 100 mg
- Dose Escalation Increase
- Initial 50 mg; following 100 mg
- Investigational Product Name
- Placebo tablet for JTT-861
- Modality
- Other
- Starting Dose
- Placebo
- Frequency
- Once daily (QD)
Related trials
Other published trials that may interest you.