Clinical trial • Phase III • Cardiology

FINERENONE for Heart failure with left ventricular systolic dysfunction

Phase III trial of FINERENONE for Heart failure with left ventricular systolic dysfunction.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Heart failure with 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

Randomised, finerenone (bay 94-8862 / finerenone bayer) added to standard of care versus matched placebo (placebo bay 948862) added to standard of care. (dosing strength variants listed in product records include 10 mg, 20 mg and 40 mg formulations; specific dosing schedule not specified in the available record.)-controlled Phase III trial in Belgium, Bulgaria, Czechia and others.

Randomised
Yes
Comparator
Finerenone (BAY 94-8862 / Finerenone Bayer) added to standard of care versus matched placebo (Placebo BAY 948862) added to standard of care. (Dosing strength variants listed in product records include 10 mg, 20 mg and 40 mg formulations; specific dosing schedule not specified in the available record.)
Target Sample Size
51
Trial Duration For Participant
90

Eligibility

Recruits 51 paediatric patients.

Vulnerable Population
Participants are children aged 6 months to <18 years (vulnerable population). Consent is obtained from parents/legal guardians and assent is obtained from children as appropriate. Age-specific subject information sheets and informed consent/assent forms are provided (small child, pre-teen, teenager, parent documents) in local languages as indicated in the provided SIS/ICF documents.

Inclusion criteria

  • {"criterion_text":"- Participants must be 6 months to <18 years old at the time when the informed consent/assent is signed."}
  • {"criterion_text":"- LV systolic dysfunction (LVSD) with left ventricular ejection fraction (LVEF) ≤ 50% at screening assessed by echocardiography"}
  • {"criterion_text":"- Elevated NT-pro BNP levels • >500 ng/l for children ≥ 6 months to < 2 years of age • >300 ng/l, for children ≥ 2 years to <18 years"}
  • {"criterion_text":"- Heart failure etiologies including 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 was at least 3 months prior to randomization); neuromuscular disorder (eg, duchenne muscular dystrophy); inborn error of metabolism; mitochondrial disorder; acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional); ischemic (eg, Kawasaki disease and postoperative heart failure [HF]); LV noncompaction."}
  • {"criterion_text":"- Receiving standard of care (SoC) treatment for heart failure according to local guidelines or investigator´s discretion and being on a stable regimen for 30 days prior to randomization"}
  • {"criterion_text":"- Study participants must have a body weight ≥ 4.0 kg at Visit 1."}

Exclusion criteria

  • {"criterion_text":"- Serum potassium: • >5.0 mmol/L for children ≥ 2 years of age at either screening or randomization visit • >5.3 mmol/L for children ≥ 6 months to < 2 years of age at either screening or randomization visit (if estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73m², threshold of > 5.0 mmol/L will be used)"}
  • {"criterion_text":"- Severe renal dysfunction with eGFR < 30 ml/min/1.73m2 at screening or randomization visit"}
  • {"criterion_text":"- Systolic blood pressure (SBP) < 5th percentile for age, sex and height at screening or randomization"}
  • {"criterion_text":"- Sustained or symptomatic arrhythmias not controlled by drug or device therapy within 30 days prior to randomization"}
  • {"criterion_text":"- Treatment with a mineralocorticoid receptor antagonist (e.g., spironolactone, eplerenone) within 30 days of randomization."}
  • {"criterion_text":"- Requirement of any intravenous (IV) vasoactive agents, mechanical ventilation, mechanical circulatory support within 30 days prior to randomization."}
  • {"criterion_text":"- Recent surgical procedure or other intervention to correct or palliate CHD within 3 months prior to randomization or anticipated to undergo cardiac surgery during the 3 months after randomization."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change in NT-proBNP from baseline to 3 months in participants receiving active study intervention compared to placebo","definition_or_measurement_approach":"Change from baseline to 3 months in NT-proBNP levels; comparison between finerenone plus standard of care versus placebo plus standard of care."}

Secondary endpoints

  • {"endpoint_text":"- Number of participants with treatment-emergent adverse events (TEAEs)","definition_or_measurement_approach":"Count of participants experiencing TEAEs during the study period."}
  • {"endpoint_text":"- Change in serum potassium levels from baseline to end of treatment (EoT)","definition_or_measurement_approach":"Change from baseline to EoT in serum potassium."}
  • {"endpoint_text":"- Change in systolic blood pressure (SBP) from baseline to EoT","definition_or_measurement_approach":"Change from baseline to EoT in systolic blood pressure."}
  • {"endpoint_text":"- Change in renal function from baseline to EoT","definition_or_measurement_approach":"Change from baseline to EoT in renal function parameters (e.g., eGFR)."}
  • {"endpoint_text":"- Change in echocardiographic parameters of left ventricular systolic function and size from baseline to EoT","definition_or_measurement_approach":"Change from baseline to EoT in echocardiographic measures of LV systolic function and size (e.g., LVEF, LV dimensions)."}
  • {"endpoint_text":"- Total number of cardiovascular outcome events, including cardiovascular death, heart transplantation, and clinical worsening of heart failure from baseline to EoT","definition_or_measurement_approach":"Count of predefined cardiovascular outcome events from baseline to EoT."}
  • {"endpoint_text":"- Maximum observed finerenone concentration in plasma after multiple doses (Cmax, md)","definition_or_measurement_approach":"Pharmacokinetic measurement of Cmax after multiple dosing."}
  • {"endpoint_text":"- Area under the curve for finerenone concentration in plasma after multiple doses (AUCτ,md)","definition_or_measurement_approach":"Pharmacokinetic measurement of AUCτ after multiple dosing."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
51
Recruitment Window Months
49
Consent Approach
Parental/legal guardian informed consent is required for minor participants; assent is obtained from children as appropriate by age. Age-specific subject information sheets and informed consent/assent forms are provided (small child, pre-teen, teen, parent documents) and are available in local languages as per the document list (e.g., EN, DE, FR, NL and multiple country-specific language versions).

Methods

  • Cartoon and animated videos (K2_Recruitment_material_Public_Cartoon_Video_*) — child-facing digital videos designed for recruitment (country-specific versions available).
  • Child comic booklets (K2_Recruitment_material_Public_Child_Comic_Booklet_*) — printed/digital materials targeting children.
  • Parent booklets (K2_Recruitment_material_Public_Parent_Booklet_*) — informational booklets for parents/guardians in country-specific languages.
  • Teen booklets (K2_Recruitment_material_Public_Teen_Booklet_*) — materials targeted to adolescent participants.
  • Tabletop materials (K2_Recruitment_material_Public_Tabletop_*) — clinic/display materials for site-based recruitment.
  • Visit scheme and recruitment procedure documents (K1_Recruitment_arrangements_Public_*) — outlines of recruitment procedures and site-level processes (country-specific documents provided).

Geography

Total Number Of Sites
47
Total Number Of Participants
60

Belgium

Earliest CTIS Part Ii Submission Date
27-11-2025
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
8
Number Of Sites
5
Number Of Participants
6

Sites

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
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
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
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

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
University Multidisciplinary Hospital For Active Treatment Sveta Ekaterina EAD
Department Name
TBD
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
MHAT National Heart Hospital EAD
Department Name
Dept. Pediatric Cardiology
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 Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Paediatric Cardiology and Rheumatology
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
11-11-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
28
Number Of Sites
2
Number Of Participants
2

Sites

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
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

Germany

Earliest CTIS Part Ii Submission Date
25-11-2025
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
15
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
University Hospital Cologne 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
09-09-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
90
Number Of Sites
4
Number Of Participants
5

Sites

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
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
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
Athens General Children's Hospital Panagioti And Aglaia Kyriakou (2nd Department)
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

Italy

Earliest CTIS Part Ii Submission Date
11-11-2025
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
29
Number Of Sites
8
Number Of Participants
10

Sites

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
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Cadiologia pediatrica e cardiopatie congenite
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
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 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
Ospedale Pediatrico Bambino Gesu
Department Name
Scompenso, Trapianto e Assistenza Meccanica Cardiocircolatoria
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
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

Portugal

Earliest CTIS Part Ii Submission Date
20-10-2025
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
51
Number Of Sites
5
Number Of Participants
7

Sites

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 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
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 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

Spain

Earliest CTIS Part Ii Submission Date
11-11-2025
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
29
Number Of Sites
7
Number Of Participants
9

Sites

Site Name
Hospital Universitario La Paz
Department Name
Cardiologia pediatrica
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
Hospital Universitario 12 De Octubre
Department Name
Cardiologia pediatrica
Principal Investigator Name
Belen Toral Vazquez
Principal Investigator Email
hospitalpac.hdoc@salud.madrid.org
Contact Person Name
Belen Toral Vazquez
Site Name
Hospital Universitario Regional De Malaga
Department Name
Cardiologia pediatrica
Principal Investigator Name
Gonzalo Cortazar Rocandio
Contact Person Name
Gonzalo Cortazar Rocandio
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Cardiologia pediatrica
Principal Investigator Name
Inmaculada Guillen Rodriguez
Principal Investigator Email
cma.hg.hvr.sspa@juntadeandalucia.es
Contact Person Name
Inmaculada Guillen Rodriguez
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Cardiologia pediatrica
Principal Investigator Name
Georgia Sarquella Brugada
Principal Investigator Email
hospitalbarcelona.atenciousuari@sjd.es
Contact Person Name
Georgia Sarquella Brugada
Site Name
Hospital Universitari Vall D Hebron
Department Name
Cardiologia pediatrica
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
Principal Investigator Name
Elena Gomez Guzman
Principal Investigator Email
sau.hrs.sspa@juntadeandalucia.es
Contact Person Name
Elena Gomez Guzman

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
3

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

Austria

Earliest CTIS Part Ii Submission Date
25-11-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
13
Number Of Sites
2
Number Of Participants
2

Sites

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
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

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
Pediatric Heart Center
Principal Investigator Name
Laszlo Ablonczy
Principal Investigator Email
ablonczyl@gmail.com
Contact Person Name
Laszlo Ablonczy
Contact Person Email
ablonczyl@gmail.com

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
Wojewodzki Szpital Specjalistyczny We Wroclawiu
Department Name
Oddz. Kardiologii Dziecięcej z Pododdz. Kardiochirurgii i Intens. Nadzoru Kardiol.
Principal Investigator Name
Pawel Czesniewicz
Principal Investigator Email
kardiolodz@wssk.wroc.pl
Contact Person Name
Pawel Czesniewicz
Contact Person Email
kardiolodz@wssk.wroc.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
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

Finland

Earliest CTIS Part Ii Submission Date
10-11-2025
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
115
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
maria.hurskainen@hus.fi
Contact Person Name
Maria Hurskainen
Contact Person Email
maria.hurskainen@hus.fi

Sponsor

Primary sponsor

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

Contract research organisations

Name
Suvoda LLC
Responsibilities
code 3
Name
DATAN Analytics GmbH
Responsibilities
code 10
Name
Carelon Research Inc
Responsibilities
Scientific advice
Name
Fisher Clinical Services GmbH
Responsibilities
code 14
Name
Swiss BioQuant AG
Responsibilities
code 4
Name
GBA Central Lab Services GmbH
Responsibilities
code 4

Third parties

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

Investigational products

Investigational Product Name
Finerenone Bayer
Active Substance
FINERENONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
40 mg
Investigational Product Name
BAY 94-8862
Active Substance
FINERENONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Dose Levels
10 mg; 20 mg; 40 mg
Maximum Dose
40 mg
Investigational Product Name
Placebo BAY 948862
Modality
Other
Combination Treatment
Yes

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