Clinical trial • Phase III • Cardiology
PELACARSEN for Atherosclerotic cardiovascular disease
Phase III trial of PELACARSEN for Atherosclerotic cardiovascular disease.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Atherosclerotic cardiovascular disease
- Trial Stage
- Phase III
- Drug Modality
- Oligonucleotide
Key dates
- Initial CTIS Submission Date
- 14-04-2025
- First CTIS Authorization Date
- 05-08-2025
Trial design
Randomised, placebo to tqj230 80 mg/0.8 ml solution for injection in pre-filled syringe with needle safety device (placebo comparator); background inclisiran is used as background treatment in participants-controlled Phase III trial in Spain, France, Italy and others.
- Randomised
- Yes
- Comparator
- Placebo to TQJ230 80 mg/0.8 mL Solution for injection in pre-filled syringe with needle safety device (placebo comparator); background inclisiran is used as background treatment in participants
- Target Sample Size
- 157
Eligibility
Recruits 157 Vulnerable population selected (isVulnerablePopulationSelected = true). No specific details on consent or assent handling for vulnerable participants are provided in the available data..
- Pregnancy Exclusion
- Pregnant or nursing women at Screening visit
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). No specific details on consent or assent handling for vulnerable participants are provided in the available data.
Inclusion criteria
- {"criterion_text":"- Male and female participants 18 to ≤80 years of age at Screening visit\n- Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit\n- On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit\n- Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized\n- On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit\n- Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit\n- Central laboratory reported LDL-C >70 mg/dL (or >1.8 mmol/L) at Screening visit"}
Exclusion criteria
- {"criterion_text":"- Prior treatment with inclisiran\n- Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit\n- Uncontrolled hypertension at Randomization/Baseline visit\n- Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1)\n- Triglycerides ≥400 mg/dL at Screening visit\n- History of malignancy of any organ system within the past 5 years\n- Myocardial infarction, stroke or other major bleeding, coronary or lower limb re-vascularization, major cardiac or non-cardiac surgery between Screening visit and Randomization/Baseline visit (Day 1)\n- Central laboratory reported platelet count <140,000 per mm3\n- Active liver disease or hepatic dysfunction at Screening visit\n- Significant kidney disease at Screening visit\n- Pregnant or nursing women at Screening visit\n- Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change in log-transformed Lp(a) concentration from baseline at Month 6","definition_or_measurement_approach":"Change in log-transformed Lp(a) concentration from baseline at Month 6"}
Secondary endpoints
- {"endpoint_text":"- Proportion of participants achieving Lp(a) levels <125 nmol/L at Month 6\n- Incidence of treatment emergent adverse events (TEAEs):\n- Incidence of treatment emergent serious adverse events (TESAEs)\n- Incidence of treatment emergent adverse events of special interest (AESI)\n- Incidence of study and treatment discontinuations due to TEAEs;\n- Observed value and change/shift from baseline in safety laboratory measures; • ECGs • Vital signs • Laboratory values (e.g. CBC, CMP, Liver Function Tests)","definition_or_measurement_approach":"Proportion achieving Lp(a) <125 nmol/L at Month 6; incidence measures are reported as counts/rates of events (TEAEs, TESAEs, AESI, discontinuations). Safety laboratory measures include ECGs, vital signs and laboratory values (e.g., CBC, CMP, liver function tests)."}
Recruitment
- Planned Sample Size
- 157
- Recruitment Window Months
- 36
- Consent Approach
- Written informed consent obtained from each adult participant. Main ICF documents available in multiple languages (English, Spanish, French, Italian, Dutch, German as per listed ICF documents). Participants are adults (18 to ≤80); no assent/parental consent procedures for minors are applicable or described. Follow-up information sheets for pregnant participants are included in some country documents.
Geography
- Total Number Of Sites
- 48
- Total Number Of Participants
- 188
Spain
- Earliest CTIS Part Ii Submission Date
- 29-04-2025
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 283
- Number Of Sites
- 11
- Number Of Participants
- 39
Sites
- Site Name
- Instituto Medico Quirurgico San Rafael S.A.
- Department Name
- 2809: Endocrinología
- Principal Investigator Name
- Alfonso Soto Gonzalez
- Principal Investigator Email
- alfonso.soto.gonzalez@sergas.es
- Contact Person Name
- Alfonso Soto Gonzalez
- Contact Person Email
- alfonso.soto.gonzalez@sergas.es
- Site Name
- Hospital Universitario De Navarra
- Department Name
- 2804: Medicina Interna
- Principal Investigator Name
- Julio Sánchez Álvarez
- Principal Investigator Email
- julio.sanchez.alvarez@navarra.es
- Contact Person Name
- Julio Sánchez Álvarez
- Contact Person Email
- julio.sanchez.alvarez@navarra.es
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- 2802: Medicina Interna
- Principal Investigator Name
- José López Miranda
- Principal Investigator Email
- jlopezmir@uco.es
- Contact Person Name
- José López Miranda
- Contact Person Email
- jlopezmir@uco.es
- Site Name
- El Hospital Universitario De Gran Canaria Dr. Negrin
- Department Name
- 2808: Cardiologia
- Principal Investigator Name
- Antonio Garcia Quintana
- Principal Investigator Email
- agarquil@gobiernodecanarias.org
- Contact Person Name
- Antonio Garcia Quintana
- Contact Person Email
- agarquil@gobiernodecanarias.org
- Site Name
- Hospital Infanta Elena
- Department Name
- 2801: Medicina Interna
- Principal Investigator Name
- Manuel Jesus Romero Jimenez
- Principal Investigator Email
- mjesus.romero.sspa@juntadeandalucia.es
- Contact Person Name
- Manuel Jesus Romero Jimenez
- Contact Person Email
- mjesus.romero.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- 2806: Cardiología
- Principal Investigator Name
- Daniel Nieto Ibáñez
- Principal Investigator Email
- dnietoi@saludcastillayleon.es
- Contact Person Name
- Daniel Nieto Ibáñez
- Contact Person Email
- dnietoi@saludcastillayleon.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- 2803: Cardiologia
- Principal Investigator Name
- Julio Nuñez Villota
- Principal Investigator Email
- juenuvi@uv.es
- Contact Person Name
- Julio Nuñez Villota
- Contact Person Email
- juenuvi@uv.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- 2800: Cardiologia
- Principal Investigator Name
- María del Pilar Mazón Ramos
- Principal Investigator Email
- pilar.mazon.ramos@sergas.es
- Contact Person Name
- María del Pilar Mazón Ramos
- Contact Person Email
- pilar.mazon.ramos@sergas.es
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- 2805: Medicina Interna
- Principal Investigator Name
- Fernando Cereto Castro
- Principal Investigator Email
- fernando.cereto@quironsalud.es
- Contact Person Name
- Fernando Cereto Castro
- Contact Person Email
- fernando.cereto@quironsalud.es
- Site Name
- Consorcio Hospital General Universitario De Valencia
- Department Name
- 2810: Medicina Interna
- Principal Investigator Name
- Francisco Puchades Gimeno
- Principal Investigator Email
- Francesc.puchades@ucv.es
- Contact Person Name
- Francisco Puchades Gimeno
- Contact Person Email
- Francesc.puchades@ucv.es
- Site Name
- Hospital Nisa Sevilla Aljarafe
- Department Name
- 2807: Endocrinología
- Principal Investigator Name
- Cristóbal Jesús Morales Portillo
- Principal Investigator Email
- MoralesPCJ@vithas.es
- Contact Person Name
- Cristóbal Jesús Morales Portillo
- Contact Person Email
- MoralesPCJ@vithas.es
France
- Earliest CTIS Part Ii Submission Date
- 04-07-2025
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 214
- Number Of Sites
- 12
- Number Of Participants
- 52
Sites
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- 2012: Cardiology
- Principal Investigator Name
- Meyer ELBAZ
- Principal Investigator Email
- elbaz.m@chu-toulouse.fr
- Contact Person Name
- Meyer ELBAZ
- Contact Person Email
- elbaz.m@chu-toulouse.fr
- Site Name
- Hopital Saint Joseph
- Department Name
- 2013:Cardiology
- Principal Investigator Name
- Patrick KHANOYAN
- Principal Investigator Email
- Pkhanoyan@hopital-saint-joseph.fr
- Contact Person Name
- Patrick KHANOYAN
- Contact Person Email
- Pkhanoyan@hopital-saint-joseph.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- 2010: Cardiology
- Principal Investigator Name
- Gilles BARONE -ROCHETTE
- Principal Investigator Email
- gbarone@chu-grenoble.fr
- Contact Person Name
- Gilles BARONE -ROCHETTE
- Contact Person Email
- gbarone@chu-grenoble.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- 2006: Cardiology
- Principal Investigator Name
- Yann PUCHEU
- Principal Investigator Email
- yann.pucheau@chu-bordeaux.fr
- Contact Person Name
- Yann PUCHEU
- Contact Person Email
- yann.pucheau@chu-bordeaux.fr
- Site Name
- Centre Hospitalier De Cholet
- Department Name
- 2014:Cardiology
- Principal Investigator Name
- Jean-Eudes TRIHAN
- Principal Investigator Email
- Jean-eudes.trihan@ch-cholet.fr
- Contact Person Name
- Jean-Eudes TRIHAN
- Contact Person Email
- Jean-eudes.trihan@ch-cholet.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- 2012: Cardiology
- Principal Investigator Name
- Etienne PUYMIRAT
- Principal Investigator Email
- etienne.puymirat@aphp.fr
- Contact Person Name
- Etienne PUYMIRAT
- Contact Person Email
- etienne.puymirat@aphp.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- 2008: Cardiology
- Principal Investigator Name
- Cyrille BERGEROT
- Principal Investigator Email
- cyrille.bergerot@chu-lyon.fr
- Contact Person Name
- Cyrille BERGEROT
- Contact Person Email
- cyrille.bergerot@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- 2002: Cardiology
- Principal Investigator Name
- François ROUBILLE
- Principal Investigator Email
- f-roubille@chu-montpellier.fr
- Contact Person Name
- François ROUBILLE
- Contact Person Email
- f-roubille@chu-montpellier.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- 2004: 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
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- 2000: Cardiology
- Principal Investigator Name
- Claire BOULETI
- Principal Investigator Email
- claire.bouleti@chu-poitiers.fr
- Contact Person Name
- Claire BOULETI
- Contact Person Email
- claire.bouleti@chu-poitiers.fr
- Site Name
- Centre Hospitalier De Beziers
- Department Name
- 2001: Cardiology
- Principal Investigator Name
- Philippe BERDAGUE
- Principal Investigator Email
- philippe.berdague@ch-beziers.fr
- Contact Person Name
- Philippe BERDAGUE
- Contact Person Email
- philippe.berdague@ch-beziers.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- 2011: Therapeutic
- Principal Investigator Name
- Cécile YELNIK
- Principal Investigator Email
- cecile.yelnik@chu-lille.fr
- Contact Person Name
- Cécile YELNIK
- Contact Person Email
- cecile.yelnik@chu-lille.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 09-07-2025
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 212
- Number Of Sites
- 10
- Number Of Participants
- 36
Sites
- Site Name
- Centro Cardiologico Monzino S.p.A.
- Department Name
- 2409: U.O. Scompenso, Cardiologia Critica e Cardiologia Riabilitativa
- Principal Investigator Name
- Jeness Campodonico
- Principal Investigator Email
- jeness.campodonico@cardiologicomonzino.it
- Contact Person Name
- Jeness Campodonico
- Contact Person Email
- jeness.campodonico@cardiologicomonzino.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- 2400: S.O.D. Clinica di Cardiologia ed Aritmologia
- Principal Investigator Name
- Federico Guerra
- Principal Investigator Email
- Federico.Guerra@ospedaliriuniti.marche.it
- Contact Person Name
- Federico Guerra
- Contact Person Email
- Federico.Guerra@ospedaliriuniti.marche.it
- Site Name
- Azienda Ospediera Sant'anna E San Sebastiano Di Caserta
- Department Name
- 2402: UOC Cardiologia Clinica a Direzione Universitaria e 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
- Santa Maria Degli Angeli Hospital
- Department Name
- 2403: S.C. Cardiologia
- Principal Investigator Name
- Marco Alberto Mojoli
- Principal Investigator Email
- marco.mojoli@asfo.sanita.fvg.it
- Contact Person Name
- Marco Alberto Mojoli
- Contact Person Email
- marco.mojoli@asfo.sanita.fvg.it
- Site Name
- Ospedale Mater Salutis Di Legnago
- Department Name
- 2405: UOC Cardiologia-Emodinamica
- Principal Investigator Name
- Antonio Mugnolo
- Principal Investigator Email
- antonio.mugnolo@aulss9.veneto.it
- Contact Person Name
- Antonio Mugnolo
- Contact Person Email
- antonio.mugnolo@aulss9.veneto.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- 2401: U.O. di Cardiologia
- Principal Investigator Name
- Cristina Panico
- Principal Investigator Email
- cristina.panico@humanitas.it
- Contact Person Name
- Cristina Panico
- Contact Person Email
- cristina.panico@humanitas.it
- Site Name
- Hospital Santa Maria Della Misericordia
- Department Name
- 2404: S.C. Medicina Interna
- Principal Investigator Name
- Matteo Pirro
- Principal Investigator Email
- Matteo.pirro@unipg.it
- Contact Person Name
- Matteo Pirro
- Contact Person Email
- Matteo.pirro@unipg.it
- Site Name
- Azienda Unita' Sanitaria Locale Toscana Sud Est
- Department Name
- 2406: U.O.C. di Cardiologia
- Principal Investigator Name
- Alessandra Bosso
- Principal Investigator Email
- alessandra.bosso@uslsudest.toscana.it
- Contact Person Name
- Alessandra Bosso
- Contact Person Email
- alessandra.bosso@uslsudest.toscana.it
- Site Name
- Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
- Department Name
- 2407: Malattie apparato Cardiovascolare
- Principal Investigator Name
- Gennaro Galasso
- Principal Investigator Email
- ggalasso@unisa.it
- Contact Person Name
- Gennaro Galasso
- Contact Person Email
- ggalasso@unisa.it
- Site Name
- Santa Maria Degli Angeli Hospital (duplicate listing not specified)
Netherlands
- Earliest CTIS Part Ii Submission Date
- 14-07-2025
- Latest Decision Or Authorization Date
- 04-02-2026
- Processing Time Days
- 205
- Number Of Sites
- 3
- Number Of Participants
- 17
Sites
- Site Name
- Haga Hospital
- Department Name
- 2602: Cardiology
- Principal Investigator Name
- Samer Somi
- Principal Investigator Email
- s.somi@hagaziekenhuis.nl
- Contact Person Name
- Samer Somi
- Contact Person Email
- s.somi@hagaziekenhuis.nl
- Site Name
- Medisch Spectrum Twente
- Department Name
- 2603: Cardiology
- Principal Investigator Name
- Paolo Zocca
- Principal Investigator Email
- g.zocca@mst.nl
- Contact Person Name
- Paolo Zocca
- Contact Person Email
- g.zocca@mst.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- 2600: Vascular Medicine
- Principal Investigator Name
- Erik Stroes
- Principal Investigator Email
- e.s.stroes@amsterdamumc.nl
- Contact Person Name
- Erik Stroes
- Contact Person Email
- e.s.stroes@amsterdamumc.nl
Germany
- Earliest CTIS Part Ii Submission Date
- 08-07-2025
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 210
- Number Of Sites
- 12
- Number Of Participants
- 44
Sites
- Site Name
- Institut fuer Diabetesforschung Muenster GmbH
- Department Name
- 2211: Institut für Diabetesforschung Münster GmbH
- Principal Investigator Name
- Ludger Rose
- Principal Investigator Email
- L.Rose@diabetes-muenster.de
- Contact Person Name
- Ludger Rose
- Contact Person Email
- L.Rose@diabetes-muenster.de
- Site Name
- MVZ Diabeteszentrum Dr. Tews GmbH
- Department Name
- 2208: MVZ Diabeteszentrum Dr. Tews GmbH
- Principal Investigator Name
- Dietrich Tews
- Principal Investigator Email
- dietrich.tews@tews-diabetes.de
- Contact Person Name
- Dietrich Tews
- Contact Person Email
- dietrich.tews@tews-diabetes.de
- Site Name
- Gesundheitsverbund Landkreis Konstanz gGmbH
- Department Name
- 2203: I Medizinische Klinik/ Studienzentrum
- Principal Investigator Name
- Marc Kollum
- Principal Investigator Email
- marc.kollum@glkn.de
- Contact Person Name
- Marc Kollum
- Contact Person Email
- marc.kollum@glkn.de
- Site Name
- Klinikum Bielefeld gGmbH
- Department Name
- 2200: Abteilung für Kardiologie und internistische Intensivmedizin
- Principal Investigator Name
- Ekaterina Stellbrink
- Principal Investigator Email
- EKATERINA.STELLBRINK@KLINIKUMBIELEFELD.DE
- Contact Person Name
- Ekaterina Stellbrink
- Contact Person Email
- EKATERINA.STELLBRINK@KLINIKUMBIELEFELD.DE
- Site Name
- Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH
- Department Name
- 2201: Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH
- Principal Investigator Name
- Christoph Axthelm
- Principal Investigator Email
- christoph.axthelm@cardiologicum.dee
- Contact Person Name
- Christoph Axthelm
- Contact Person Email
- christoph.axthelm@cardiologicum.dee
- Site Name
- ze:ro Praxen MVZ fuer Nierenerkrankungen und Bluthochdruck GmbH Mannheim
- Department Name
- 2202: MVZ für Nierenerkrankungen/ Bluthochdruck
- Principal Investigator Name
- Peter Salbach
- Principal Investigator Email
- Peter.Salbach@zero-praxen.de
- Contact Person Name
- Peter Salbach
- Contact Person Email
- Peter.Salbach@zero-praxen.de
- Site Name
- Robert Bosch Krankenhaus GmbH
- Department Name
- 2214: Kardiologie und Angiologie
- Principal Investigator Name
- Peter Ong
- Principal Investigator Email
- peter.ong@rbk.de
- Contact Person Name
- Peter Ong
- Contact Person Email
- peter.ong@rbk.de
- Site Name
- Klinische Forschung Hannover-Mitte GmbH
- Department Name
- 2205: Klinische Forschung Hannover-Mitte GmbH
- Principal Investigator Name
- Jan Wagner
- Principal Investigator Email
- Jan.wagner@pratia.com
- Contact Person Name
- Jan Wagner
- Contact Person Email
- Jan.wagner@pratia.com
- Site Name
- MVZ am Kuechwald GmbH ambulantes HerzCentrum
- Department Name
- 2207: MVZ am Kuechwald GmbH amulantes HerzCentrum
- Principal Investigator Name
- Jan Ernstberger
- Principal Investigator Email
- j.ernstberger@poliklinik.de
- Contact Person Name
- Jan Ernstberger
- Contact Person Email
- j.ernstberger@poliklinik.de
- Site Name
- Diamedikum Potsdam
- Department Name
- 2212: Diamedikum Potsdam
- Principal Investigator Name
- Jens Ringel
- Principal Investigator Email
- J.Ringel@diamedikum-potsdam.de
- Contact Person Name
- Jens Ringel
- Contact Person Email
- J.Ringel@diamedikum-potsdam.de
- Site Name
- Universitaetsklinikum Leipzig AöR
- Department Name
- 2213: Klinik und Poliklinik fuer Kardiologie
- Principal Investigator Name
- Irina Mueller-Kozarez
- Principal Investigator Email
- Irina.Mueller-Kozarez@medizin.uni-leipzig.de
- Contact Person Name
- Irina Mueller-Kozarez
- Contact Person Email
- Irina.Mueller-Kozarez@medizin.uni-leipzig.de
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Syneos Health Inc.
- Responsibilities
- code: 1
- Name
- Icon Clinical Research Limited
- Responsibilities
- code: 1; also code: 15 (Endpoint Adjudication) for another entry
- Name
- IQVIA Limited
- Responsibilities
- code: 1; additional entry code: 3
- Name
- Parexel International (IRL) Limited
- Responsibilities
- code: 12
- Name
- Labcorp Early Development Laboratories Limited
- Responsibilities
- code: 4
Third parties
- {"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":"Syneos Health Inc.","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"code: 15; Ancillary Supplies","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Eurofins Genomics Europe AgriGenomics Products & Services A/S","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Labcorp Early Development Laboratories Limited","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"DATAMAP-Gesellschaft fuer Datenmanagement Datenanalyse und Datenpraesentation mbH","duties_or_roles":"code: 10; code: 15 (DMC)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited (IDEA CEC Management)","duties_or_roles":"code: 15 (Endpoint Adjudication); code: 6","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code: 12","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited (additional entry)","duties_or_roles":"code: 3","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- TQJ230
- Active Substance
- PELACARSEN
- Modality
- Oligonucleotide
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Starting Dose
- 80 mg/0.8 mL
- Maximum Dose
- 960 mg
- Investigational Product Name
- INCLISIRAN
- Active Substance
- INCLISIRAN
- Modality
- Oligonucleotide
- Routes Of Administration
- SOLUTION FOR INJECTION
- Maximum Dose
- 1200 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
- Combination Treatment
- Yes
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