Clinical trial • Phase II • Cardiology

Pelacarsen for Calcific aortic valve stenosis

Phase II trial of Pelacarsen for Calcific aortic valve stenosis.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Calcific aortic valve stenosis
Trial Stage
Phase II
Drug Modality
Oligonucleotide

Key dates

Initial CTIS Submission Date
02-02-2024
First CTIS Authorization Date
24-05-2024

Trial design

Randomised, pelacarsen (tqj230) - described product: tqj230 (pelacarsen) solution for injection in pre-filled syringe, 80 mg/0.8 ml; route: subcutaneous use. comparator: matching placebo to tqj230 80 mg/0.8 ml solution for injection in pre-filled syringe. dose schedule not specified in the ctis record.-controlled Phase II trial in Portugal, Austria, Netherlands and others.

Randomised
Yes
Comparator
Pelacarsen (TQJ230) - described product: TQJ230 (pelacarsen) solution for injection in pre-filled syringe, 80 mg/0.8 mL; route: subcutaneous use. Comparator: matching placebo to TQJ230 80 mg/0.8 mL solution for injection in pre-filled syringe. Dose schedule not specified in the CTIS record.
Target Sample Size
268
Trial Duration For Participant
1080

Eligibility

Recruits 268 Vulnerable populations selected (isVulnerablePopulationSelected: true). Informed consent documents (Main ICF - Adult) are provided in multiple country languages; there is a specific follow-up ICF for pregnant participants. No paediatric assent/consent documentation is provided..

Pregnancy Exclusion
Pregnant or nursing women
Vulnerable Population
Vulnerable populations selected (isVulnerablePopulationSelected: true). Informed consent documents (Main ICF - Adult) are provided in multiple country languages; there is a specific follow-up ICF for pregnant participants. No paediatric assent/consent documentation is provided.

Inclusion criteria

  • {"criterion_text":"- Male and female ≥50 to <80 years of age\n- Lipoprotein(a) ≥175 nmol/L, measured at the central laboratory\n- Mild or moderate calcific aortic valve stenosis, as assessed by the core laboratory\n- At the randomization visit, participant must be optimally treated for existing CV risk factors"}

Exclusion criteria

  • {"criterion_text":"- Severe calcific aortic valve stenosis as assessed by the core laboratory\n- History of hemorrhagic stroke or other major bleeding\n- Platelet count <140,000 per mm3\n- Active liver disease or hepatic dysfunction\n- Significant kidney disease\n- Pregnant or nursing women\n- Uncontrolled hypertension\n- History of malignancy of any organ system"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change in peak aortic jet velocity from baseline to month 36","definition_or_measurement_approach":"Change from baseline to month 36 in peak aortic jet velocity measured by echocardiography (assessed by core laboratory)"}
  • {"endpoint_text":"- Change in aortic valve calcium score from baseline to month 36","definition_or_measurement_approach":"Change from baseline to month 36 in aortic valve calcium score measured by computed tomography (CT)"}

Secondary endpoints

  • {"endpoint_text":"- Change in lipoprotein(a) levels from baseline to month 12","definition_or_measurement_approach":"Change from baseline to month 12 in Lp(a) levels measured at the central laboratory"}
  • {"endpoint_text":"- Change in fibrocalcific thickening of the aortic valve from baseline to month 36","definition_or_measurement_approach":"Change from baseline to month 36 in fibrocalcific thickening of the aortic valve assessed by contrast computed tomography"}
  • {"endpoint_text":"- Time from randomization to first occurrence of composite clinical endpoint event, defined as reaching either: • Unplanned CAVS related hospital admission • Aortic valve intervention • Death related to calcific aortic valve stenosis","definition_or_measurement_approach":"Time-to-event analysis from randomization to first occurrence of the composite clinical endpoint (unplanned CAVS-related hospital admission, aortic valve intervention, or death related to CAVS)"}
  • {"endpoint_text":"- Safety endpoints (including adverse events/serious adverse events, safety laboratory parameters, vital signs) collected from baseline to end of study","definition_or_measurement_approach":"Safety data collected from baseline to end of study including AEs/SAEs, safety laboratory parameters and vital signs"}

Recruitment

Planned Sample Size
268
Recruitment Window Months
75
Consent Approach
Informed consent obtained from adult participants using Main ICF - Adult documents. ICFs and subject information sheets are provided in multiple country/language versions (examples: English, Portuguese, German, Dutch, Czech, Spanish, French, Italian, Danish). There are specific ICFs for follow-up of pregnant participants. No paediatric/assent procedures are documented.

Methods

  • Country-specific recruitment arrangements documents (K1) uploaded for participating countries (examples: K1_Recruitment Arrangements - Country_1_PT, AT, NL, CZ, ES, BE, IT, DK, FR, DE).
  • Advertisements and recruitment materials (K2) available (country-specific K2_Advertisements documents).
  • Third-party support: Jumo Health USA Inc. listed with role 'Development, printing and shipping of recruitment materials'; other vendors support translation, eCOA, ePRO and advertising logistics (e.g., RWS Life Sciences Inc., Medidata, Kayentis).

Geography

Total Number Of Sites
71
Total Number Of Participants
234

Portugal

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
13-10-2025
Processing Time Days
529
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Centro Hospitalar E Universitario De Coimbra E.P.E.
Department Name
#1800: Serviço de Cardiologia
Principal Investigator Name
Pedro Monteiro
Principal Investigator Email
uicc@ulscoimbra.min-saude.pt
Contact Person Name
Pedro Monteiro
Contact Person Email
uicc@ulscoimbra.min-saude.pt
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
#1801:Serviço de Cardiologia
Principal Investigator Name
Ricardo Fontes Carvalho
Principal Investigator Email
fontes.carvalho@chvng-min-saude.pt
Contact Person Name
Ricardo Fontes Carvalho
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
#1802:Serviço de Cardiologia
Principal Investigator Name
Antonio Gaspar
Principal Investigator Email
antonio.gaspar@hb.min-saude.pt
Contact Person Name
Antonio Gaspar
Contact Person Email
antonio.gaspar@hb.min-saude.pt
Site Name
Galo Saude Parcerias Cascais S.A.
Department Name
#1803:Serviço de Cardiologia
Principal Investigator Name
Marta Afonso Nogueira
Contact Person Name
Marta Afonso Nogueira

Austria

Earliest CTIS Part Ii Submission Date
30-04-2024
Latest Decision Or Authorization Date
13-10-2025
Processing Time Days
531
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Imed19-Privat
Department Name
Internal Medicine
Principal Investigator Name
Christopher Adlbrecht
Principal Investigator Email
c.adlbrecht@imed19.at
Contact Person Name
Christopher Adlbrecht
Contact Person Email
c.adlbrecht@imed19.at
Site Name
Klinik Favoriten
Department Name
Internal Medicine V, Cardiology
Principal Investigator Name
Diana Bonderman
Principal Investigator Email
Diana.bondermann@gesundheitsverbund.at
Contact Person Name
Diana Bonderman
Site Name
Medical University Of Vienna
Department Name
Internal Medicine
Principal Investigator Name
Christian Hengstenberg
Principal Investigator Email
Christian.hengstenberg@meduniwien.ac.at
Contact Person Name
Christian Hengstenberg
Site Name
Medizinische Universitaet Innsbruck
Department Name
Internal Medicine III
Principal Investigator Name
Martin Reindl
Principal Investigator Email
Martin.reindl@tirol-kliniken.at
Contact Person Name
Martin Reindl

Netherlands

Earliest CTIS Part Ii Submission Date
30-04-2024
Latest Decision Or Authorization Date
21-10-2025
Processing Time Days
539
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Academisch Medisch Centrum
Department Name
#1700: Heart center, department of cardiology
Principal Investigator Name
S.M. Boekholdt
Principal Investigator Email
s.m.boekholdt@amsterdamumc.nl
Contact Person Name
S.M. Boekholdt
Contact Person Email
s.m.boekholdt@amsterdamumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
#1704:Cardiology
Principal Investigator Name
M.J.G. Leening
Principal Investigator Email
m.leening@erasmusmc.nl
Contact Person Name
M.J.G. Leening
Contact Person Email
m.leening@erasmusmc.nl
Site Name
OLVG Stichting
Department Name
#1703: Cardiology
Principal Investigator Name
R. Halbmeijer
Principal Investigator Email
r.halbmeijer@olvg.nl
Contact Person Name
R. Halbmeijer
Contact Person Email
r.halbmeijer@olvg.nl
Site Name
St. Antonius Ziekenhuis
Department Name
#1705:Cardiology
Principal Investigator Name
J.M. Ten Berg
Principal Investigator Email
j.ten.berg@antoniusziekenhuis.nl
Contact Person Name
J.M. Ten Berg
Site Name
Maasstad Ziekenhuis Stichting
Department Name
#1702: Interventional Cardiology
Principal Investigator Name
Valerie Paradies
Principal Investigator Email
ParadiesV2@maasstadziekenhuis.nl
Contact Person Name
Valerie Paradies

Czechia

Earliest CTIS Part Ii Submission Date
24-04-2024
Latest Decision Or Authorization Date
13-10-2025
Processing Time Days
537
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
Edumed s.r.o.
Department Name
1104: Kardiologicka ambulance
Principal Investigator Name
Jiri Vesely
Principal Investigator Email
vesely.edumed@gmail.com
Contact Person Name
Jiri Vesely
Contact Person Email
vesely.edumed@gmail.com
Site Name
Institute For Clinical And Experimental Medicine
Department Name
1105: Oddělení neinvazivní kardiologie
Principal Investigator Name
Martin Kotrc
Principal Investigator Email
martin.kotrc@ikem.cz
Contact Person Name
Martin Kotrc
Contact Person Email
martin.kotrc@ikem.cz
Site Name
Edumed s.r.o.
Department Name
1107: Kardiologie
Principal Investigator Name
Terezia Svarcova
Principal Investigator Email
tereza.svarcova@edu-med.cz
Contact Person Name
Terezia Svarcova
Contact Person Email
tereza.svarcova@edu-med.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
#1108: Kardiologická klinika 2. LF UK a FN Motol
Principal Investigator Name
Hana Línková
Principal Investigator Email
hana.linkova@fnmotol.cz
Contact Person Name
Hana Línková
Contact Person Email
hana.linkova@fnmotol.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
1102: II.interni klinika - Klinika kardiologie a angiologie
Principal Investigator Name
Jan Belohlavek
Principal Investigator Email
jan.belohlavek@vfn.cz
Contact Person Name
Jan Belohlavek
Contact Person Email
jan.belohlavek@vfn.cz

Spain

Earliest CTIS Part Ii Submission Date
26-04-2024
Latest Decision Or Authorization Date
15-10-2025
Processing Time Days
537
Number Of Sites
7
Number Of Participants
23

Sites

Site Name
Hospital Universitario De Salamanca
Department Name
#1905:Cardiología
Principal Investigator Name
Luis Miguel Rincon Diaz
Principal Investigator Email
lmrincon@secardiologia.es
Contact Person Name
Luis Miguel Rincon Diaz
Contact Person Email
lmrincon@secardiologia.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
#1900:Cardiología
Principal Investigator Name
Jose Zamorano
Principal Investigator Email
zamorano@secardiologia.es
Contact Person Name
Jose Zamorano
Contact Person Email
zamorano@secardiologia.es
Site Name
Hospital San Pedro De Alcantara
Department Name
#1903:Cardiología
Principal Investigator Name
Jose Javier Gómez-Barrado
Principal Investigator Email
jjgomezbarrado@gmail.com
Contact Person Name
Jose Javier Gómez-Barrado
Contact Person Email
jjgomezbarrado@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
#1904:Cardiología
Principal Investigator Name
Jorge Solis
Principal Investigator Email
jorge.solis@salud.madrid.org
Contact Person Name
Jorge Solis
Contact Person Email
jorge.solis@salud.madrid.org
Site Name
Hospital Clinico San Carlos
Department Name
#1901:Cardiología
Principal Investigator Name
Leopoldo Perez de Isla
Principal Investigator Email
leopisla@hotmail.com
Contact Person Name
Leopoldo Perez de Isla
Contact Person Email
leopisla@hotmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
#1906: Cardiología
Principal Investigator Name
Juan Carlos Castillo Dominguez
Contact Person Name
Juan Carlos Castillo Dominguez
Site Name
Hospital Universitario La Paz
Department Name
#1907: Cardiología
Principal Investigator Name
Jose Raul Moreno Gomez
Principal Investigator Email
joseraul.moreno@salud.madrid.org
Contact Person Name
Jose Raul Moreno Gomez

Belgium

Earliest CTIS Part Ii Submission Date
26-04-2024
Latest Decision Or Authorization Date
12-12-2025
Processing Time Days
581
Number Of Sites
6
Number Of Participants
17

Sites

Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
#1002: Cardiology
Principal Investigator Name
Fabian Demeure
Principal Investigator Email
Fabian.demeure@uclouvain.be
Contact Person Name
Fabian Demeure
Contact Person Email
Fabian.demeure@uclouvain.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
#1000: Cardiology
Principal Investigator Name
Michiel Dumoulein
Principal Investigator Email
Michiel.dumoulein@azgroeninge.be
Contact Person Name
Michiel Dumoulein
Site Name
Algemeen Ziekenhuis Delta
Department Name
#1005: Cardiology
Principal Investigator Name
Vanhaverbeke Maarten
Principal Investigator Email
maarten.vanhaverbeke@azdelta.be
Contact Person Name
Vanhaverbeke Maarten
Site Name
Ziekenhuis Oost Limburg
Department Name
#1001: Cardiology
Principal Investigator Name
David Verhaert
Principal Investigator Email
David.verhaert@zol.be
Contact Person Name
David Verhaert
Contact Person Email
David.verhaert@zol.be
Site Name
Azorg
Department Name
#1004: Cardiology
Principal Investigator Name
Philippe Vanduynhoven
Principal Investigator Email
philippe.vanduynhoven@azorg.be
Contact Person Name
Philippe Vanduynhoven
Contact Person Email
philippe.vanduynhoven@azorg.be
Site Name
Algemeen Ziekenhuis Groeninge (additional site listed)
Department Name
#1000: Cardiology
Principal Investigator Name
Michiel Dumoulein
Principal Investigator Email
Michiel.dumoulein@azgroeninge.be
Contact Person Name
Michiel Dumoulein

Italy

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
652
Number Of Sites
12
Number Of Participants
51

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
#1605: S.O.D. Clinica di Cardiologia ed Aritmologia - Dipartimento di Scienze Cardiovascolari
Principal Investigator Name
Federico Guerra
Principal Investigator Email
f.guerra@staff.univpm.it
Contact Person Name
Federico Guerra
Contact Person Email
f.guerra@staff.univpm.it
Site Name
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Department Name
#1607: Department of Molecular Medicine and Department of Angiocardioneurology
Principal Investigator Name
Giuseppe Lembo
Principal Investigator Email
lembo@neuromed.it
Contact Person Name
Giuseppe Lembo
Contact Person Email
lembo@neuromed.it
Site Name
University Hospital Of Ferrara
Department Name
#1602: U.O. di Cardiologia ed UTIC Università degli Studi
Principal Investigator Name
Alessandro Fucili
Principal Investigator Email
a.fucili@ospfe.it
Contact Person Name
Alessandro Fucili
Contact Person Email
a.fucili@ospfe.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Department Name
#1608: U.O.C. Cardiology
Principal Investigator Name
Andrea Rinaldi
Principal Investigator Email
rinaldiandrea19@gmail.com
Contact Person Name
Andrea Rinaldi
Contact Person Email
rinaldiandrea19@gmail.com
Site Name
Azienda Ospedaliera Ospedale Niguarda Ca Granda
Department Name
#1600: S.C. Cardiologia 4
Principal Investigator Name
Alessandro Maloberti
Principal Investigator Email
alessandro.maloberti@ospedaleniguarda.it
Contact Person Name
Alessandro Maloberti
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
#1601: U.O.C. di Cardiologia Università degli Studi Presidio Ospedaliero di Brescia
Principal Investigator Name
Elio Gorga
Principal Investigator Email
cardiologia@asst-spedalicivili.it
Contact Person Name
Elio Gorga
Site Name
Ospedale Galeazzi S.p.A.
Department Name
#1606: U.O. Cardiologia Universitaria ed Imaging Cardiaco
Principal Investigator Name
Daniele Andreini
Principal Investigator Email
daniele.andreini@grupposandonato.it
Contact Person Name
Daniele Andreini
Site Name
Centro Cardiologico Monzino S.p.A.
Department Name
#1603: Dipartimento di Cardiologia peri-operatoria e Imaging Cardiovascolare
Principal Investigator Name
Gianluca Pontone
Principal Investigator Email
gianluca.pontone@cardiologicomonzino.it
Contact Person Name
Gianluca Pontone
Site Name
Azienda Ospedaliera Sant'anna E San Sebastiano Di Caserta
Department Name
#1611: UOC Cardiologia Clinica e Direzione Universitara UTIC
Principal Investigator Name
Paolo Calabrò
Principal Investigator Email
paolo.calabro@unicampania.it
Contact Person Name
Paolo Calabrò
Contact Person Email
paolo.calabro@unicampania.it
Site Name
Azienda Ospedale-Universita Padova
Department Name
#1604: U.O.C. Clinica Medica 3 Dipartimento di Medicina - DIMED Università degli Studi
Principal Investigator Name
Giuseppe Maiolino
Principal Investigator Email
giuseppe.maiolino@aopd.veneto.it
Contact Person Name
Giuseppe Maiolino
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
#1610: U.O.C. Cardiologia 1
Principal Investigator Name
Michele Senni
Principal Investigator Email
msenni@asst-pg23.it
Contact Person Name
Michele Senni
Contact Person Email
msenni@asst-pg23.it
Site Name
Santa Maria Degli Angeli Hospital
Department Name
#1612: SC Cardiologia
Principal Investigator Name
Marco Alberto Mojoli
Principal Investigator Email
marco.mojoli@asfo.sanita.fvg.it
Contact Person Name
Marco Alberto Mojoli

Denmark

Earliest CTIS Part Ii Submission Date
10-05-2024
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
573
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Esbjerg Sygehus
Department Name
#1204: Kardiologisk Afdeling - Kardiologisk Forsknings Enhed
Principal Investigator Name
Kristian Korsgaard Thomsen
Principal Investigator Email
Kristian.Korsgaard.Thomsen@rsyd.dk
Contact Person Name
Kristian Korsgaard Thomsen
Site Name
Region Sjaelland
Department Name
#1203: Kardiologisk Afdeling - Kardiologisk Forsknings Enhed
Principal Investigator Name
Niels Eske Bruun
Principal Investigator Email
nbru@regionsjaelland.dk
Contact Person Name
Niels Eske Bruun
Contact Person Email
nbru@regionsjaelland.dk
Site Name
Region Midtjylland
Department Name
#1200: Hjertesygdomme Forskning
Principal Investigator Name
Ajmal Shafaq
Principal Investigator Email
ajmal.shafaq@midt.rm.dk
Contact Person Name
Ajmal Shafaq
Contact Person Email
ajmal.shafaq@midt.rm.dk
Site Name
Hvidovre Hospital
Department Name
#1205: Ambulatorium for hjertesygdomme
Principal Investigator Name
Jens Dahlgaard Hove
Principal Investigator Email
Jens.Dahlgaard.Hove@regionh.dk
Contact Person Name
Jens Dahlgaard Hove
Contact Person Email
Jens.Dahlgaard.Hove@regionh.dk

France

Earliest CTIS Part Ii Submission Date
19-03-2024
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
672
Number Of Sites
9
Number Of Participants
22

Sites

Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
#1307 Cardiology and vascular
Principal Investigator Name
Erwan Donal
Principal Investigator Email
erwan.donal@chu-rennes.fr
Contact Person Name
Erwan Donal
Contact Person Email
erwan.donal@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
#1306: Cardiology
Principal Investigator Name
Claire Bouleti
Principal Investigator Email
claire.bouleti@gmail.com
Contact Person Name
Claire Bouleti
Contact Person Email
claire.bouleti@gmail.com
Site Name
Hopital Saint Antoine
Department Name
#1300: Cardiology
Principal Investigator Name
Franck Boccara
Principal Investigator Email
franck.boccara@aphp.fr
Contact Person Name
Franck Boccara
Contact Person Email
franck.boccara@aphp.fr
Site Name
Hopital Universitaire Pitie Salpetriere
Department Name
#1302: Cardiology
Principal Investigator Name
Paul GUEDENEY
Principal Investigator Email
paul.guedeney@aphp.fr
Contact Person Name
Paul GUEDENEY
Contact Person Email
paul.guedeney@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
#1304: Vascular medecin
Principal Investigator Name
Emmanuel Messas
Principal Investigator Email
emmanuel.messas@aphp.fr
Contact Person Name
Emmanuel Messas
Contact Person Email
emmanuel.messas@aphp.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
#1308: Cardiology
Principal Investigator Name
Yves Cottin
Principal Investigator Email
yves.cottin@chu-dijon.fr
Contact Person Name
Yves Cottin
Contact Person Email
yves.cottin@chu-dijon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
#1309: Cardiology
Principal Investigator Name
Julien TERNACLE
Principal Investigator Email
julien.ternacle@chu-bordeaux.fr
Contact Person Name
Julien TERNACLE
Site Name
Centre Hospitalier Universitaire De Rennes (additional listing)
Department Name
#1307 Cardiology and vascular
Principal Investigator Name
Erwan Donal
Principal Investigator Email
erwan.donal@chu-rennes.fr
Contact Person Name
Erwan Donal
Contact Person Email
erwan.donal@chu-rennes.fr
Site Name
Hopital Saint Antoine (additional listing)
Department Name
#1300: Cardiology
Principal Investigator Name
Franck Boccara
Principal Investigator Email
franck.boccara@aphp.fr
Contact Person Name
Franck Boccara
Contact Person Email
franck.boccara@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
14-05-2024
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
668
Number Of Sites
15
Number Of Participants
49

Sites

Site Name
Herzzentrum Leipzig GmbH
Department Name
#1421: Herzzentrum Leipzig Kardiologie
Principal Investigator Name
Alexander Jobs
Principal Investigator Email
Alexander.Jobs@helios-gesundheit.de
Contact Person Name
Alexander Jobs
Site Name
ClinPhenomics CVC GmbH
Department Name
#1407: Studienzentrum Frankfurt
Principal Investigator Name
Martin Duersch
Principal Investigator Email
m.duersch@clph.de
Contact Person Name
Martin Duersch
Contact Person Email
m.duersch@clph.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
#1419: Medizinische Klinik und Poliklinik II, Herzzentrum
Principal Investigator Name
Georg Nickenig
Principal Investigator Email
Georg.Nickenig@ukbonn.de
Contact Person Name
Georg Nickenig
Contact Person Email
Georg.Nickenig@ukbonn.de
Site Name
Kardiopraxis Schirmer
Department Name
#1418
Principal Investigator Name
Stephan Schirmer
Principal Investigator Email
schirmer@kardiopraxis-schirmer.de
Contact Person Name
Stephan Schirmer
Site Name
Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH
Department Name
#1405: Zentrum für Klinische Prüfungen
Principal Investigator Name
Gregor Simonis
Principal Investigator Email
prof.simonis@praxisklinik-dresden.de
Contact Person Name
Gregor Simonis
Site Name
Deutsches Herzzentrum Muenchen
Department Name
#1400: Department of Cardiovascular Diseases
Principal Investigator Name
Moritz von Scheidt
Principal Investigator Email
Moritz.scheidt@tum.de
Contact Person Name
Moritz von Scheidt
Contact Person Email
Moritz.scheidt@tum.de
Site Name
Klinikum Oldenburg AöR
Department Name
#1415: Universitätsklinik für Innere Medizin- Kardiologie
Principal Investigator Name
Bastian Schrader
Principal Investigator Email
bastian.schrader@uni-oldenburg.de
Contact Person Name
Bastian Schrader
Site Name
Klinikum Westmuensterland GmbH
Department Name
#1420: I. Medizinische Klinik für Kardiologie und Angiologie
Principal Investigator Name
Alessandro Cuneo
Principal Investigator Email
alessandro.cuneo@kwml.de
Contact Person Name
Alessandro Cuneo
Contact Person Email
alessandro.cuneo@kwml.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
#1403: Kardiologie und internistische Intensivmedizin
Principal Investigator Name
Martin Bergmann
Principal Investigator Email
org-ham-Proresea7452@asklepios.com
Contact Person Name
Martin Bergmann
Site Name
Charite Universitaetsmedizin Berlin KöR (Augustenburger Platz)
Department Name
#1411: Medizinischen Klinik für Endokrinologie und
Principal Investigator Name
Elisabeth Steinhagen-Thiessen
Principal Investigator Email
elisabeth.steinhagen-thiessen@gmx.de
Contact Person Name
Elisabeth Steinhagen-Thiessen
Site Name
Universitaetsklinikum Essen AöR
Department Name
1413: Klinik für Kardiologie und Angiologie
Principal Investigator Name
Amir-Abbas Mahabadi
Principal Investigator Email
Amir-abbas.mahabadi@uk-essen.de
Contact Person Name
Amir-Abbas Mahabadi
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
#1416: Universitäres Herz- und Gefäßzentrum Hamburg, Klinik für Kardiologie
Principal Investigator Name
Natalie Arnold
Principal Investigator Email
n.arnold@uke.de
Contact Person Name
Natalie Arnold
Contact Person Email
n.arnold@uke.de
Site Name
ze:ro Praxen MVZ Mannheim
Department Name
#1417: Praxis für Kardiologie und Pneumologie
Principal Investigator Name
Jan Saenger
Principal Investigator Email
Jan.saenger@zero-praxen.de
Contact Person Name
Jan Saenger
Contact Person Email
Jan.saenger@zero-praxen.de
Site Name
Praxis für Innere Medizin (Muenster)
Department Name
#1414
Principal Investigator Name
Christian Fechtrup
Principal Investigator Email
fechtrup@innere-medizin.de
Contact Person Name
Christian Fechtrup
Contact Person Email
fechtrup@innere-medizin.de
Site Name
Charite Universitaetsmedizin Berlin KöR (Hindenburgdamm)
Department Name
#1410: Deutsches Herzzentrum der Charité
Principal Investigator Name
Elisabeth Steinhagen-Thiessen
Principal Investigator Email
elisabeth.steinhagen-thiessen@gmx.de
Contact Person Name
Elisabeth Steinhagen-Thiessen

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Endpoint adjudication of hypersensitivity events; listed sponsor duties
Name
PAREXEL International GmbH
Responsibilities
Ancillary supplies
Name
IQVIA Limited
Responsibilities
Drug supply logistics; other sponsor duties
Name
Syneos Health Inc.
Responsibilities
Sponsor duties (code:1)

Third parties

  • {"country":"Denmark","full_name":"Specific Pharma A/S","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Translation, licensing, and eCOA migration","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"DATAMAP-Gesellschaft fuer Datenmanagement Datenanalyse und Datenpraesentation mbH","duties_or_roles":"code:10","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Endpoint adjudication of hypersensitivity events","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Novartis Pharmaceuticals Corp.","duties_or_roles":"Long-term repository lab samples","organisation_type":"Pharmaceutical company"}
  • {"country":"Austria","full_name":"Abf Pharmaceutical Services GmbH","duties_or_roles":"Local depot for storage and distribution of AxMP to sites/Destruction IMP and AxMP","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Novartis International AG","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Labcorp Early Development Laboratories Limited","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"PAREXEL International GmbH","duties_or_roles":"Ancillary supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Kayentis","duties_or_roles":"Electronic Patient Reported Outcomes ((e)PRO), data collection via tablet and PRO management","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medpace Reference Laboratories LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Development, printing and shipping of recruitment materials","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Drug supply logistics; code:3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Biotel Research LLC","duties_or_roles":"code:13","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited (second entry)","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
  • {"country":"Austria","full_name":"Mag. Andreas Raffeiner GmbH","duties_or_roles":"code:8","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code:12","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"DMC analysis","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited (second entry)","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
TQJ230
Active Substance
Pelacarsen
Modality
Oligonucleotide
Routes Of Administration
Subcutaneous use
Route
Subcutaneous
Authorisation Status
prodAuthStatus=1
Dose Levels
80 mg (product described as 80 mg/0.8 mL solution for injection)
Maximum Dose
Max daily dose: 80 mg; max total dose amount: 3040 mg
Investigational Product Name
Placebo to TQJ230 80 mg/0.8 mL Solution for injection in pre-filled syringe with needle safety device
Modality
Other

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