Clinical trial • Phase III • Cardiology

FINERENONE for Heart failure | Left ventricular systolic dysfunction

Phase III trial of FINERENONE for Heart failure | Left ventricular systolic dysfunction. open-label. 56 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Heart failure | Left ventricular systolic dysfunction
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
19-08-2025
First CTIS Authorization Date
05-12-2025

Trial design

open-label Phase III trial in Hungary, Austria, Belgium and others.

Open Label
Yes
Target Sample Size
56
Trial Duration For Participant
270

Eligibility

Recruits 56 paediatric patients.

Vulnerable Population
Paediatric population (from birth to 18 years). Vulnerability recognised and managed via parent/legal guardian informed consent and age‑appropriate assent documents. The submission includes multiple subject information and informed consent forms and assent forms for children and adolescents (examples in the dossier: child ICFs and assent forms for various age groups, parent ICFs, and expecting-parents materials). Materials are provided per-country / language (country-specific ICFs and recruitment leaflets), indicating consent by guardian and assent where appropriate for younger participants.

Inclusion criteria

  • {"criterion_text":"- For participants rolling over from randomized controlled trial (RCT): Prior participation in the finerenone Phase 3 study FIORE (21466) and not permanently discontinued from the study intervention prior to the end of treatment (EoT) visit in FIORE"}
  • {"criterion_text":"- For newly enrolled infants <6 months of age: LV systolic dysfunction (LVSD) with left ventricular ejection fraction (LVEF) ≤ 50% at screening assessed by echocardiography"}
  • {"criterion_text":"- For newly enrolled infants <6 months of age: Elevated NT-pro BNP levels (> 500 mg/L) at screening"}
  • {"criterion_text":"- For newly enrolled infants <6 months of age: Heart failure etiologies include congenital heart defects (CHD) with biventricular physiology and systemic LV; idiopathic cardiomyopathy (CM); familial/inherited and/or genetic CM; history of myocarditis (diagnosis of an acute episode at least 3 months prior to treatment assignment); neuromuscular disorder; inborn error of metabolism; mitochondrial disorder; acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional); ischemic (e.g., Kawasaki disease and postoperative HF); LV noncompaction"}
  • {"criterion_text":"- For newly enrolled infants < 6 months of age: Receiving standard of care (SoC) treatment for heart failure according to local guidelines or investigator´s discretion (on a stable regimen for 30 days before baseline)."}
  • {"criterion_text":"- Newly enrolled newborns and infants < 6 months of age must have a body weight of ≥3 kg at Visit 1."}

Exclusion criteria

  • {"criterion_text":"- For participants rolling over from RCT: To roll-over to FIORELLO, all participants: Potassium (K+) >5.5 mmol/L After unblinding: • For participants who received finerenone in FIORE: K+ >5.5 mmol/ L • For participants who received placebo in FIORE: K+ >5.0 mmol/L for children ≥2 years of age, and >5.3 mmol/L for children <2 years of age (if eGFR is <60 mL/min/1.73m² for participants <2 years of age, the serum potassium threshold of >5.0 mmol/L will be used for exclusion)."}
  • {"criterion_text":"- For newly enrolled newborns and infants < 6 months of age: Potassium ≥ 5.3 mmol/l (if eGFR is <60 mL/min/1.73m², the serum potassium threshold of >5.0 mmol/L will be used for exclusion)"}
  • {"criterion_text":"- For participants rolling over from RCT: Severe renal dysfunction with estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 at FIORE EoT or Visit 1."}
  • {"criterion_text":"- For newly enrolled infants < 6 months of age: Severe renal dysfunction with eGFR < 30 ml/min/1.73m2 at screening or Visit 1."}
  • {"criterion_text":"- Treatment with a mineralocorticoid receptor antagonist, other than the study intervention, (e.g., spironolactone, eplerenone) within 30 days of Visit 1."}
  • {"criterion_text":"- Requirement of any intravenous (IV) vasoactive agents; mechanical ventilation; mechanical circulatory support; sustained or symptomatic arrhythmias not controlled by drug or device therapy within 30 days prior to study treatment."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of participants with treatment emergent adverse events (TEAEs)","definition_or_measurement_approach":"Counting participants with TEAEs (treatment-emergent adverse events) reported during study treatment"}
  • {"endpoint_text":"- Change in serum potassium levels from baseline to Day 270± 7 (Visit 6, EoT)","definition_or_measurement_approach":"Change from baseline to Day 270±7 in serum potassium (laboratory measurement)"}
  • {"endpoint_text":"- Change in systolic blood pressure (SBP) from baseline to Day 270± 7 (Visit 6, EoT)","definition_or_measurement_approach":"Change from baseline to Day 270±7 in systolic blood pressure measured clinically"}
  • {"endpoint_text":"- Change in estimated glomerular filtration rate (eGFR) from baseline to Day 270± 7 (Visit 6, EoT)","definition_or_measurement_approach":"Change from baseline to Day 270±7 in estimated GFR (clinical laboratory calculation)"}

Secondary endpoints

  • {"endpoint_text":"- Change in NT-proBNP from baseline to Day 270± 7 (Visit 6, EoT)","definition_or_measurement_approach":"Change from baseline to Day 270±7 in NT-proBNP (biomarker laboratory measurement)"}
  • {"endpoint_text":"- Change in key echocardiographic parameters of left ventricular systolic function from baseline to Day 270± 7 (Visit 6, EoT)","definition_or_measurement_approach":"Change from baseline to Day 270±7 in key echocardiographic measures of LV systolic function (echocardiography)"}
  • {"endpoint_text":"- Maximum observed finerenone concentration in plasma after multiple doses (Cmax, md)","definition_or_measurement_approach":"Pharmacokinetic measurement: observed maximum plasma concentration after multiple dosing"}
  • {"endpoint_text":"- Area under the curve for finerenone concentration in plasma after multiple doses (AUCτ,md)","definition_or_measurement_approach":"Pharmacokinetic parameter: AUC over dosing interval after multiple doses"}
  • {"endpoint_text":"- Taste and texture questionnaire of the pediatric formulation","definition_or_measurement_approach":"Patient/parent-reported questionnaire assessing acceptability/palatability of pediatric formulation"}

Recruitment

Planned Sample Size
56
Recruitment Window Months
58
Consent Approach
Informed consent is obtained from parent(s)/legal guardian(s) for paediatric participants; age-appropriate assent forms are used for children and adolescents. The dossier includes multiple subject information sheets and ICFs for parents, adults, and children in age-specific editions (examples: core child ICFs, assent forms for various age bands, expecting-parents documents). Materials are prepared per country/language as evidenced by multiple country-specific ICF and recruitment documents.

Methods

  • Recruitment via participating hospital and clinic sites (site-based recruitment) across the listed countries (see country-specific recruitment documents K1/K2).
  • Roll-over recruitment of participants from the prior finerenone Phase 3 study FIORE (21466) (participants rolling over from the RCT).
  • Use of site-specific parent leaflets, visit schemes and recruitment materials (K2 parent leaflets and visit scheme documents referenced per country).

Geography

Total Number Of Sites
51
Total Number Of Participants
61

Hungary

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
61
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Gottsegen National Cardiovascular Center
Department Name
Gyermekszív Kozpont
Principal Investigator Name
Laszlo Ablonczy
Principal Investigator Email
ablonczyl@gmail.com
Contact Person Name
Laszlo Ablonczy
Contact Person Email
ablonczyl@gmail.com

Austria

Earliest CTIS Part Ii Submission Date
21-11-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
17
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Kepler Universitaetsklinikum GmbH
Department Name
Klinik für Kinderkardiologie
Principal Investigator Name
Andreas Tulzer
Principal Investigator Email
andreas.tulzer@kepleruniklinikum.at
Contact Person Name
Andreas Tulzer
Site Name
Medical University Of Vienna
Department Name
Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische Kardiologie
Principal Investigator Name
Andreas Hanslik
Principal Investigator Email
andreas.hanslik@meduniwien.ac.at
Contact Person Name
Andreas Hanslik

Belgium

Earliest CTIS Part Ii Submission Date
27-11-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
12
Number Of Sites
5
Number Of Participants
4

Sites

Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Pediatric Cardiology
Principal Investigator Name
Luc Bruyndonckx
Principal Investigator Email
luc.bruyndonckx@uza.be
Contact Person Name
Luc Bruyndonckx
Contact Person Email
luc.bruyndonckx@uza.be
Site Name
CHC MontLegia
Department Name
Pediatric Cardiology
Principal Investigator Name
Isabelle Loeckx
Principal Investigator Email
Isabelle.loeckx@chc.be
Contact Person Name
Isabelle Loeckx
Contact Person Email
Isabelle.loeckx@chc.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Pediatric Cardiology
Principal Investigator Name
Laura Muino Mosquera
Principal Investigator Email
laura.muinomosquera@uzgent.be
Contact Person Name
Laura Muino Mosquera
Contact Person Email
laura.muinomosquera@uzgent.be
Site Name
UZ Leuven
Department Name
Pediatric Cardiology
Principal Investigator Name
Bjorn Cools
Principal Investigator Email
Bjorn.Cools@uzleuven.be
Contact Person Name
Bjorn Cools
Contact Person Email
Bjorn.Cools@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Pediatric Cardiology
Principal Investigator Name
Stephane Moniotte
Principal Investigator Email
stephane.moniotte@saintluc.uclouvain.be
Contact Person Name
Stephane Moniotte

Bulgaria

Earliest CTIS Part Ii Submission Date
10-11-2025
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
30
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
MHAT National Heart Hospital EAD
Department Name
Department of Child Cardiology at Pediatric Clinic
Principal Investigator Name
Anna Kaneva Nencheva
Principal Investigator Email
nkb@hearthospital.bg
Contact Person Name
Anna Kaneva Nencheva
Contact Person Email
nkb@hearthospital.bg
Site Name
Medical Center Nora-Heart Ltd.
Department Name
Child Cardiology
Principal Investigator Name
Rumen Marinov
Principal Investigator Email
reception@medcenterheart.com
Contact Person Name
Rumen Marinov
Contact Person Email
reception@medcenterheart.com
Site Name
University Multidisciplinary Hospital For Active Treatment Sveta Ekaterina EAD
Department Name
Clinic of cardiology
Principal Investigator Name
Pencho Kratunkov
Principal Investigator Email
contact@i-health.bg
Contact Person Name
Pencho Kratunkov
Contact Person Email
contact@i-health.bg
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Pediatric Clinic
Principal Investigator Name
Lyubov Atanasova Chochkova Bukova
Principal Investigator Email
klinikadetska@gmail.com
Contact Person Name
Lyubov Atanasova Chochkova Bukova
Contact Person Email
klinikadetska@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
31-10-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
39
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Fakultni Nemocnice Brno
Department Name
Dětská nemocnice - Pediatrická klinika
Principal Investigator Name
Jana Tuckova
Principal Investigator Email
fnbrno@fnbrno.cz
Contact Person Name
Jana Tuckova
Contact Person Email
fnbrno@fnbrno.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Dětské kardiocentrum 2. LF UK a FN Motol
Principal Investigator Name
Karel Koubsky
Principal Investigator Email
detske.kardiocentrum@fnmotol.cz
Contact Person Name
Karel Koubsky

Germany

Earliest CTIS Part Ii Submission Date
07-11-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
31
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Universitaetsklinikum Koeln AöR
Department Name
Kinderkardiologie
Principal Investigator Name
Markus Khalil
Contact Person Name
Markus Khalil
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Kinderheilkunde II - Kinderkardiologie, Pulmologie, Intensivmedizin
Principal Investigator Name
Vanya Icheva
Principal Investigator Email
vanya.icheva@med.uni-tuebingen.de
Contact Person Name
Vanya Icheva
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Kinderherzzentrum und Zentrum für angeborene Herzfehler
Principal Investigator Name
David Backhoff
Principal Investigator Email
Kinderkardiologie.Gi@uk-gm.de
Contact Person Name
David Backhoff
Contact Person Email
Kinderkardiologie.Gi@uk-gm.de

Greece

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
82
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
Department Name
Cardiology Department
Principal Investigator Name
Sofia Loukopoulou
Principal Investigator Email
kardiologiko@aglaiakyriakou.gr
Contact Person Name
Sofia Loukopoulou
Contact Person Email
kardiologiko@aglaiakyriakou.gr
Site Name
Onassis Cardiac Surgery Center
Department Name
Department of Pediatric Cardiology and Adult Congenital Heart Disease
Principal Investigator Name
George Vagenakis
Principal Investigator Email
pediatric.cardio.onasseio@gmail.com
Contact Person Name
George Vagenakis
Site Name
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
Department Name
2nd University Department of Pediatrics
Principal Investigator Name
Marietta Charakida
Principal Investigator Email
2ppk@med.uoa.gr
Contact Person Name
Marietta Charakida
Contact Person Email
2ppk@med.uoa.gr
Site Name
Nosokomeio Paidon I Agia Sofia
Department Name
Cardiology Department
Principal Investigator Name
Aikaterini Giannakopoulou
Principal Investigator Email
paidocardio.agsofia1@gmail.com
Contact Person Name
Aikaterini Giannakopoulou
Contact Person Email
paidocardio.agsofia1@gmail.com

Portugal

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
56
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Pediatric Cardiology Department
Principal Investigator Name
Antonio Pires
Principal Investigator Email
antonio.pires@ulscoimbra.min-saude.pt
Contact Person Name
Antonio Pires
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Pediatric Cardiology
Principal Investigator Name
Conceicao Trigo Pereira
Principal Investigator Email
maria.pereira8@ulssjose.min-saude.pt
Contact Person Name
Conceicao Trigo Pereira
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Pediatric Cardiology
Principal Investigator Name
Joana Miranda
Principal Investigator Email
joana.miranda@chporto.min-saude.pt
Contact Person Name
Joana Miranda
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Pediatric Department
Principal Investigator Name
Ana Luísa Costa
Principal Investigator Email
ana.rodrigues.costa@ulssjoao.min-saude.pt
Contact Person Name
Ana Luísa Costa
Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
Pediatric Cardiology Department
Principal Investigator Name
Rui Anjos
Principal Investigator Email
ranjos@chlo.min-saude.pt
Contact Person Name
Rui Anjos
Contact Person Email
ranjos@chlo.min-saude.pt

Spain

Earliest CTIS Part Ii Submission Date
05-11-2025
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
35
Number Of Sites
9
Number Of Participants
9

Sites

Site Name
Hospital Universitario Regional De Malaga
Department Name
Cardiologia pediatrica - Patient Visits
Principal Investigator Name
Gonzalo Cortazar Rocandio
Contact Person Name
Gonzalo Cortazar Rocandio
Site Name
Hospital Universitario 12 De Octubre
Department Name
Cardiologia pediatrica - Patient Visits
Principal Investigator Name
Belen Toral Vazquez
Principal Investigator Email
hospitalpac.hdoc@salud.madrid.org
Contact Person Name
Belen Toral Vazquez
Site Name
Hospital Universitari Vall D Hebron
Department Name
Cardiologia pediatrica - Patient Visits
Principal Investigator Name
Diana Carolina Juzga Corrales
Principal Investigator Email
uac_ami@vallhebron.cat
Contact Person Name
Diana Carolina Juzga Corrales
Contact Person Email
uac_ami@vallhebron.cat
Site Name
Hospital Universitario Reina Sofia
Department Name
Cardiologia pediatrica - Patient Visits
Principal Investigator Name
Elena Gomez Guzman
Principal Investigator Email
sau.hrs.sspa@juntadeandalucia.es
Contact Person Name
Elena Gomez Guzman
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Cardiologia pediatrica - Patient Visits
Principal Investigator Name
Georgia Sarquella Brugada
Principal Investigator Email
hospitalbarcelona.atenciousuari@sjd.es
Contact Person Name
Georgia Sarquella Brugada
Site Name
Hospital Universitario La Paz
Department Name
Cardiologia pediatrica - Patient Visits
Principal Investigator Name
Diana Salas Mera
Principal Investigator Email
atepac.hulp@salud.madrid.org
Contact Person Name
Diana Salas Mera
Contact Person Email
atepac.hulp@salud.madrid.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Cardiologia pediatrica - Patient Visits
Principal Investigator Name
Inmaculada Guillen Rodriguez
Principal Investigator Email
cma.hg.hvr.sspa@juntadeandalucia.es
Contact Person Name
Inmaculada Guillen Rodriguez
Site Name
Hospital Universitario Reina Sofia (additional site listed)
Department Name
Cardiologia pediatrica - Patient Visits
Principal Investigator Name
Elena Gomez Guzman
Principal Investigator Email
sau.hrs.sspa@juntadeandalucia.es
Contact Person Name
Elena Gomez Guzman
Site Name
Hospital Universitario Regional De Malaga (additional site entry)
Department Name
Cardiologia pediatrica - Patient Visits
Principal Investigator Name
Gonzalo Cortazar Rocandio
Contact Person Name
Gonzalo Cortazar Rocandio

Sweden

Earliest CTIS Part Ii Submission Date
09-09-2025
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
87
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Barnhjärtcentrum
Principal Investigator Name
Michal Odermarsky
Principal Investigator Email
studiesupport.sus@skane.se
Contact Person Name
Michal Odermarsky
Contact Person Email
studiesupport.sus@skane.se

Poland

Earliest CTIS Part Ii Submission Date
11-11-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
28
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Klinika Kardiologii
Principal Investigator Name
Anna Mazurek-Kula
Principal Investigator Email
sek43@iczmp.edu.pl
Contact Person Name
Anna Mazurek-Kula
Contact Person Email
sek43@iczmp.edu.pl
Site Name
Instytut Pomnik Centrum Zdrowia Dziecka
Department Name
Klinika Kardiologii
Principal Investigator Name
Lidia Ziolkowska
Principal Investigator Email
oddzial.kardiologia@ipczd.pl
Contact Person Name
Lidia Ziolkowska
Contact Person Email
oddzial.kardiologia@ipczd.pl
Site Name
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Kardiologii Dziecięcej
Principal Investigator Name
Jacek Kusa
Principal Investigator Email
kardiologia@gczd.katowice.pl
Contact Person Name
Jacek Kusa
Contact Person Email
kardiologia@gczd.katowice.pl
Site Name
Wojewodzki Szpital Specjalistyczny We Wroclawiu
Department Name
Rozwojowy Oddział Kardiologii Dzięcięcej
Principal Investigator Name
Pawel Czesniewicz
Principal Investigator Email
kardiolodz@wssk.wroc.pl
Contact Person Name
Pawel Czesniewicz
Contact Person Email
kardiolodz@wssk.wroc.pl

Italy

Earliest CTIS Part Ii Submission Date
07-11-2025
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
33
Number Of Sites
10
Number Of Participants
10

Sites

Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Cadiologia pediatrica
Principal Investigator Name
Chiara Riggi
Principal Investigator Email
direzioneaziendale@cittadellasalute.to.it
Contact Person Name
Chiara Riggi
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Cardiologia pediatrica ed dell'età evolutiva
Principal Investigator Name
Andrea Donti
Principal Investigator Email
segr.card.ped@aosp.bo.it
Contact Person Name
Andrea Donti
Contact Person Email
segr.card.ped@aosp.bo.it
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Unità Terapie Cardiovascolari Avanzate
Principal Investigator Name
Rachele Adorisio
Principal Investigator Email
scompenso@opbg.net
Contact Person Name
Rachele Adorisio
Contact Person Email
scompenso@opbg.net
Site Name
Azienda Ospedaliera Dei Colli
Department Name
Malattie Rare e Genetiche Cardiovascolari
Principal Investigator Name
Giuseppe Limongelli
Contact Person Name
Giuseppe Limongelli
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Struttura semplice dipartimentale cardiologia pediatrica
Principal Investigator Name
Simona Anna Marcora
Principal Investigator Email
cardioped@ospedaleniguarda.it
Contact Person Name
Simona Anna Marcora
Contact Person Email
cardioped@ospedaleniguarda.it
Site Name
Azienda Ospedaliera di Padova
Department Name
UOC Cardiologia Pediatrica
Principal Investigator Name
Giovanni Di Salvo
Contact Person Name
Giovanni Di Salvo
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
Cardiologia
Principal Investigator Name
Maria Elena Derchi
Principal Investigator Email
ambulatoriocardiologia@gaslini.org
Contact Person Name
Maria Elena Derchi
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Cardiologia 2 - Cardiopatie Congenite del bambino e dell'adulto
Principal Investigator Name
Francesca Raimondi
Contact Person Name
Francesca Raimondi
Site Name
Azienda Ospedaliera Dei Colli (repeat entry)
Department Name
Malattie Rare e Genetiche Cardiovascolari
Principal Investigator Name
Giuseppe Limongelli
Contact Person Name
Giuseppe Limongelli
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino (repeat entry)
Department Name
Cadiologia pediatrica
Principal Investigator Name
Chiara Riggi
Principal Investigator Email
direzioneaziendale@cittadellasalute.to.it
Contact Person Name
Chiara Riggi

Finland

Earliest CTIS Part Ii Submission Date
10-11-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
28
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
HUS-yhtymae
Department Name
Uusi lastensairaala, kardiologia
Principal Investigator Name
Maria Hurskainen
Principal Investigator Email
lastentutkimukset@hus.fi
Contact Person Name
Maria Hurskainen
Contact Person Email
lastentutkimukset@hus.fi

Sponsor

Primary sponsor

Full Name
Bayer AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Fisher Clinical Services GmbH
Responsibilities
sponsorDuties code: 14
Name
Suvoda LLC
Responsibilities
sponsorDuties code: 3
Name
DATAN Analytics GmbH
Responsibilities
sponsorDuties code: 10
Name
Carelon Research Inc
Responsibilities
scientific advice

Third parties

  • {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Swiss BioQuant AG","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"GBA Central Lab Services GmbH","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"DATAN Analytics GmbH","duties_or_roles":"sponsorDuties code: 10","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Carelon Research Inc","duties_or_roles":"scientific advice","organisation_type":"Industry"}

Investigational products

Investigational Product Name
BAY 94-8862
Active Substance
FINERENONE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Dose Levels
20 mg
Maximum Dose
20 mg
Investigational Product Name
Finerenone
Active Substance
FINERENONE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Dose Levels
10 mg
Maximum Dose
10 mg
Investigational Product Name
Finerenone Bayer (granules for oral suspension)
Active Substance
FINERENONE
Modality
Small molecule
Routes Of Administration
Oral (oral suspension)
Route
Oral (suspension)
Authorisation Status
Authorised
Dose Levels
40 mg
Maximum Dose
40 mg
Combination Treatment
Yes

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