Clinical trial • Phase II • Cardiology

Aficamten for Hypertrophic cardiomyopathy

Phase II trial of Aficamten for Hypertrophic cardiomyopathy. open-label, none/not specified-controlled. 674 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Hypertrophic cardiomyopathy
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
24-05-2024
First CTIS Authorization Date
28-06-2024

Trial design

open-label, none/not specified-controlled Phase II trial across 58 sites in Hungary, Iceland, Poland and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
674

Eligibility

Recruits 674 adults.

Inclusion criteria

  • {"criterion_text":"- 1. Completion of a Cytokinetics study investigating aficamten. If unable to complete due to circumstances not related to compliance or safety, Medical Monitor may review and determine eligibility.\n- 2. Left ventricular ejection fraction (LVEF) ≥ 55%."}

Exclusion criteria

  • {"criterion_text":"- 1. Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.\n- 2. Has participated in another investigational device or drug study or received an investigational device or drug < 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.\n- 3. Since completion of a previous study of aficamten has: - Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) < 30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate < 100 bpm and/or rhythm is stable > 30 days. - Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation).\n- 4. Had a confirmed LVEF < 40% with an associated dose interruption during participation in a prior study with aficamten.\n- 5. History of implantable cardioverter-defibrillator (ICD) placement within 30 days prior to screening."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Patient incidence of reported adverse events (AEs)","definition_or_measurement_approach":"Incidence measured as the number/proportion of patients reporting adverse events during study participation (reported AEs)."}
  • {"endpoint_text":"- 2. Patient incidence of reported serious adverse events (SAEs)","definition_or_measurement_approach":"Incidence measured as the number/proportion of patients reporting serious adverse events during study participation (reported SAEs)."}
  • {"endpoint_text":"- 3. Patient incidence of left ventricular ejection fraction (LVEF) <50%","definition_or_measurement_approach":"Incidence measured as the number/proportion of patients with LVEF <50% during study participation (based on LVEF assessments)."}

Secondary endpoints

  • {"endpoint_text":"- 1. Change from baseline values through end of participation in: − Peak LVOT-G at rest and with Valsalva provocation − Proportion of patients with resting LVOT-G <30 mmHg − Proportion of patients with post-Valsalva LVOT-G <50 mmHg − Proportion of patients with post-Valsalva LVOT-G <30 mmHg − Proportion of patients with LVEF ≥50%, resting LVOT-G <30 mmHg, and post-Valsalva LVOT-G <50 mmHg","definition_or_measurement_approach":"Change from baseline measured through end of participation for peak LVOT gradient at rest and with Valsalva and proportions of patients meeting specified LVOT-G and LVEF thresholds (serial echocardiographic/physiologic assessments)."}
  • {"endpoint_text":"- 2. Time to the following event through last follow-up - First resting LVOT-G <30 mmHg − First post-Valsalva LVOT-G <50 mmHg − First post-Valsalva LVOT-G <30 mmHg − First LVEF ≥50%, resting LVOT-G <30 mmHg, and post-Valsalva LVOT-G <50 mmHg","definition_or_measurement_approach":"Time-to-event endpoints measured from baseline to first occurrence of each listed event, censored at last follow-up."}

Recruitment

Planned Sample Size
674
Recruitment Window Months
60
Consent Approach
Informed consent is obtained from adult participants using country-specific subject information and informed consent forms. Main ICFs and optional consent documents (eg, optional cardiac MRI/CMR sub-study consent, pregnant partner/participant information) are provided; ICF documents are available in multiple languages for participating countries (English, French, Italian, German, Dutch, Portuguese, Spanish, Polish, Hungarian, Czech, Icelandic, Greek, Danish). Consent is provided by the participant (no assent process described).

Geography

Total Number Of Sites
58
Total Number Of Participants
222

Hungary

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
04-02-2026
Processing Time Days
628
Number Of Sites
2
Number Of Participants
25

Sites

Site Name
University Of Szeged
Department Name
Belgyógyászati Klinika, Kardiológiai Központ
Principal Investigator Name
Robert Szabolcs Sepp
Principal Investigator Email
sepprobert@gmail.com
Contact Person Name
Robert Szabolcs Sepp
Contact Person Email
sepprobert@gmail.com
Site Name
Semmelweis University
Department Name
Városmajori Szív és Érgyógyászati Klinika
Principal Investigator Name
Béla Merkely
Principal Investigator Email
merkely.bela@kardio.sote.hu
Contact Person Name
Béla Merkely
Contact Person Email
merkely.bela@kardio.sote.hu

Iceland

Earliest CTIS Part Ii Submission Date
26-06-2025
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
228
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Landspitali
Department Name
Department of Cardiology, Hjartagátt 10D
Principal Investigator Name
Berglind Adalsteinsdottir
Principal Investigator Email
bergla@landspitali.is
Contact Person Name
Berglind Adalsteinsdottir
Contact Person Email
bergla@landspitali.is

Poland

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
08-02-2026
Processing Time Days
632
Number Of Sites
2
Number Of Participants
17

Sites

Site Name
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Department Name
Centrum Wsparcia Badań Klinicznych
Principal Investigator Name
Artur Oreziak
Principal Investigator Email
aoreziak@ikard.pl
Contact Person Name
Artur Oreziak
Contact Person Email
aoreziak@ikard.pl
Site Name
Kardio Brynow Sp. z o.o.
Principal Investigator Name
Wojciech Wojakowski
Principal Investigator Email
wwojakowski@sum.edu.pl
Contact Person Name
Wojciech Wojakowski
Contact Person Email
wwojakowski@sum.edu.pl

Italy

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
630
Number Of Sites
7
Number Of Participants
19

Sites

Site Name
Careggi University Hospital
Department Name
Unit Cardiomiopatie, SOD Cardiologia Generale Ambulatorio di Cardiologia San Luca
Principal Investigator Name
Iacopo Olivotto
Principal Investigator Email
iacopo.olivotto@unifi.it
Contact Person Name
Iacopo Olivotto
Contact Person Email
iacopo.olivotto@unifi.it
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
SC Cardiologia via Valdoni 7, 34149 Trieste, Italy
Principal Investigator Name
Gianfranco Sinagra
Principal Investigator Email
gianfranco.sinagra@asuits.sanita.fvg.it
Contact Person Name
Gianfranco Sinagra
Site Name
Fondazione Toscana Gabriele Monasterio
Department Name
U.O.C. Cardiologia e Medicina Cardiovascolare
Principal Investigator Name
Michele Emdin
Principal Investigator Email
michele.emdin@ftgm.it
Contact Person Name
Michele Emdin
Contact Person Email
michele.emdin@ftgm.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
DAI Scienze Cardiovascolari, Diagnostica Immagini e Rete Tempo Dipendente Emergenze Cardiovascolari
Principal Investigator Name
Maria Angela Losi
Principal Investigator Email
mariaangela.losi@unina.it
Contact Person Name
Maria Angela Losi
Contact Person Email
mariaangela.losi@unina.it
Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
Dipartimento di Medicina Clinica e Molecolare
Principal Investigator Name
Beatrice Musumeci
Principal Investigator Email
beatrice.musumeci@uniroma1.it
Contact Person Name
Beatrice Musumeci
Contact Person Email
beatrice.musumeci@uniroma1.it
Site Name
Policlinico San Donato S.p.A.
Department Name
Dipartimento Cardiologia Via Morandi 30, San Donato Milanese (MI), Italy
Principal Investigator Name
Massimo Piepoli
Principal Investigator Email
massimo.piepoli@grupposandonato.it
Contact Person Name
Massimo Piepoli
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Cardiologia 2 - Insufficienza Cardiaca E Trapianti
Principal Investigator Name
Enrico Ammirati
Principal Investigator Email
Enrico.ammirati@ospedaleniguarda.it
Contact Person Name
Enrico Ammirati

France

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
627
Number Of Sites
9
Number Of Participants
36

Sites

Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Cardiology department
Principal Investigator Name
Olivier Lairez
Principal Investigator Email
lairez.o@chu-toulouse.fr
Contact Person Name
Olivier Lairez
Contact Person Email
lairez.o@chu-toulouse.fr
Site Name
Clinique Du Millenaire
Department Name
Cardiology department
Principal Investigator Name
Jean-Etienne Ricci
Principal Investigator Email
jean.etienne.ricci@outlook.com
Contact Person Name
Jean-Etienne Ricci
Contact Person Email
jean.etienne.ricci@outlook.com
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Département de Cardiologie
Principal Investigator Name
Albert Alain Hagege
Principal Investigator Email
albert.hagege@aphp.fr
Contact Person Name
Albert Alain Hagege
Contact Person Email
albert.hagege@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hôpital Cardiologique Haut-Lévêque
Principal Investigator Name
Patricia Reant
Principal Investigator Email
recherche.cardiomyopathies@chu-bordeaux.fr
Contact Person Name
Patricia Reant
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service de Cardiologie et Maladies Vasculaires
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 Montpellier
Department Name
Cardiology Intensive Care unit (USIC)
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
Centre Hospitalier Universitaire De Nantes
Department Name
Clinique Cardiologique et des Maladies Vasculaires
Principal Investigator Name
Jean-Noël Trochu
Principal Investigator Email
patricia.charpentier@chu-nantes.fr
Contact Person Name
Jean-Noël Trochu
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Cardiologie
Principal Investigator Name
Damien Logeart
Principal Investigator Email
Damien.logeart@aphp.fr
Contact Person Name
Damien Logeart
Contact Person Email
Damien.logeart@aphp.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service de cardiologie
Principal Investigator Name
Gilbert Habib
Principal Investigator Email
Gilbert.habib@ap-hm.fr
Contact Person Name
Gilbert Habib
Contact Person Email
Gilbert.habib@ap-hm.fr

Netherlands

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
636
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Cardiology
Principal Investigator Name
Michelle Michels
Principal Investigator Email
m.michels@erasmus.nl
Contact Person Name
Michelle Michels
Contact Person Email
m.michels@erasmus.nl
Site Name
Academisch Medisch Centrum
Department Name
Cardiology
Principal Investigator Name
Ahmad Amin
Principal Investigator Email
a.s.amin@amsterdamumc.nl
Contact Person Name
Ahmad Amin
Contact Person Email
a.s.amin@amsterdamumc.nl
Site Name
Universiteit Maastricht
Department Name
Cardiology
Principal Investigator Name
Christian Knackstedt
Principal Investigator Email
c.knackstedt@mumc.nl
Contact Person Name
Christian Knackstedt
Contact Person Email
c.knackstedt@mumc.nl

Portugal

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
05-02-2026
Processing Time Days
629
Number Of Sites
4
Number Of Participants
3

Sites

Site Name
Hospital Da Luz S.A.
Department Name
Cardiology
Principal Investigator Name
Alexandra Toste
Principal Investigator Email
atoste@hospitaldaluz.pt
Contact Person Name
Alexandra Toste
Contact Person Email
atoste@hospitaldaluz.pt
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Cardiology Department
Principal Investigator Name
Silvia Rosa
Principal Investigator Email
silvia.rosa@ulssjose.min-saude.pt
Contact Person Name
Silvia Rosa
Site Name
Hospital Cuf Descobertas S.A.
Department Name
Cardiology Department
Principal Investigator Name
Rui Guerreiro
Principal Investigator Email
rui.a.guerreiro@cuf.pt
Contact Person Name
Rui Guerreiro
Contact Person Email
rui.a.guerreiro@cuf.pt
Site Name
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
Department Name
Cardiology
Principal Investigator Name
José Bastos
Principal Investigator Email
mesquita.bastos.11170@chbv.min-saude.pt
Contact Person Name
José Bastos

Denmark

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
627
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Odense University Hospital
Department Name
Department of Cardiology
Principal Investigator Name
Thomas Morris Hey
Principal Investigator Email
Thomas.morris.hey@rsyd.dk
Contact Person Name
Thomas Morris Hey
Contact Person Email
Thomas.morris.hey@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Department of Cardiology
Principal Investigator Name
Kristian Kragholm
Principal Investigator Email
kdks@rn.dk
Contact Person Name
Kristian Kragholm
Contact Person Email
kdks@rn.dk
Site Name
Rigshospitalet
Department Name
The Heart Center, Deparment of Cardiology
Principal Investigator Name
Henning Bundgaard
Principal Investigator Email
Henning.bundgaard@regionh.dk
Contact Person Name
Henning Bundgaard
Contact Person Email
Henning.bundgaard@regionh.dk
Site Name
Copenhagen University Hospital
Department Name
Department of Cardiology
Principal Investigator Name
Jens Jakob Thune
Principal Investigator Email
Jens.jakob.thune@regionh.dk
Contact Person Name
Jens Jakob Thune
Contact Person Email
Jens.jakob.thune@regionh.dk
Site Name
Aarhus Universitetshospital
Department Name
Department of Cardiology
Principal Investigator Name
Morten Jensen
Principal Investigator Email
Morten.jensen@auh.rm.dk
Contact Person Name
Morten Jensen
Contact Person Email
Morten.jensen@auh.rm.dk

Czechia

Earliest CTIS Part Ii Submission Date
14-05-2024
Latest Decision Or Authorization Date
04-02-2026
Processing Time Days
631
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
II. Interní klinika kardiologie a angiologie 1. LF UK a VFN v Praze
Principal Investigator Name
David Zemanek
Principal Investigator Email
david.zemanek@vfn.cz
Contact Person Name
David Zemanek
Contact Person Email
david.zemanek@vfn.cz

Spain

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
05-02-2026
Processing Time Days
629
Number Of Sites
13
Number Of Participants
73

Sites

Site Name
Hospital Clinico San Carlos
Department Name
Cardiology Service
Principal Investigator Name
María Alejandra Restrepo Córdoba
Principal Investigator Email
mariaalejandra.restrepo@salud.madrid.org
Contact Person Name
María Alejandra Restrepo Córdoba
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Cardiología
Principal Investigator Name
Juan Ramon Gimeno Blanes
Principal Investigator Email
jgimeno@secardiologia.es
Contact Person Name
Juan Ramon Gimeno Blanes
Contact Person Email
jgimeno@secardiologia.es
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Cardiología
Principal Investigator Name
Roberto Barriales Villa
Principal Investigator Email
rbarrialesv@gmail.com
Contact Person Name
Roberto Barriales Villa
Contact Person Email
rbarrialesv@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Cardiología
Principal Investigator Name
Maria Luisa Pena Pena
Principal Investigator Email
mluisa.pena.sspa@juntadeandalucia.es
Contact Person Name
Maria Luisa Pena Pena
Site Name
Hospital de la Santa Creu i Sant Pau
Department Name
Cardiology Service
Principal Investigator Name
Marta De Antonio Ferrer
Principal Investigator Email
mantoniof@santpau.cat
Contact Person Name
Marta De Antonio Ferrer
Contact Person Email
mantoniof@santpau.cat
Site Name
Hospital Son Llatzer
Department Name
Cardiología
Principal Investigator Name
Tomas Vicente Ripoll Vera
Principal Investigator Email
tripoll@hsll.es
Contact Person Name
Tomas Vicente Ripoll Vera
Contact Person Email
tripoll@hsll.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Cardiología
Principal Investigator Name
Rafael Jesus Hidalgo Urbano
Principal Investigator Email
rjhidalur@yahoo.es
Contact Person Name
Rafael Jesus Hidalgo Urbano
Contact Person Email
rjhidalur@yahoo.es
Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
Cardiology Service
Principal Investigator Name
Raquel Bilbao Quesada
Principal Investigator Email
raquel.bilbao.quesada@sergas.es
Contact Person Name
Raquel Bilbao Quesada
Site Name
Hospital Universitario De Salamanca
Department Name
Cardiología
Principal Investigator Name
Luis Miguel Rincon Diaz
Principal Investigator Email
lmrincond@saludcastillayleon.es
Contact Person Name
Luis Miguel Rincon Diaz
Site Name
Hospital Clinic De Barcelona
Department Name
Cardiología
Principal Investigator Name
Ana Garcia Alvarez
Principal Investigator Email
anagarci@clinic.cat
Contact Person Name
Ana Garcia Alvarez
Contact Person Email
anagarci@clinic.cat
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Cardiología
Principal Investigator Name
Pablo Garcia Pavia
Contact Person Name
Pablo Garcia Pavia
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Cardiology Service
Principal Investigator Name
Maria Angeles Espinosa Castro
Principal Investigator Email
mariaangeles.espinosa@salud.madrid.org
Contact Person Name
Maria Angeles Espinosa Castro
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Cardiology Service
Principal Investigator Name
José Manuel García Pinilla
Principal Investigator Email
pinilla@uma.es
Contact Person Name
José Manuel García Pinilla
Contact Person Email
pinilla@uma.es

Germany

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
05-02-2026
Processing Time Days
629
Number Of Sites
7
Number Of Participants
9

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Kardiologie
Principal Investigator Name
Frank Edelmann
Principal Investigator Email
frank.edelmann@charite.de
Contact Person Name
Frank Edelmann
Contact Person Email
frank.edelmann@charite.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Klinik für Kardiologie, Angiologie und Pneumologie
Principal Investigator Name
Benjamin Meder
Principal Investigator Email
benjamin.meder@med.uni-heidelberg.de
Contact Person Name
Benjamin Meder
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Kardiologie und Pneumologie
Principal Investigator Name
Sören Brandenburg
Principal Investigator Email
soeren.brandenburg@med.uni-goettingen.de
Contact Person Name
Sören Brandenburg
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Deutsches Zentrum für Herzinsuffizienz Würzburg (DZHI)
Principal Investigator Name
Stefan Störk
Principal Investigator Email
stoerk_s@ukw.de
Contact Person Name
Stefan Störk
Contact Person Email
stoerk_s@ukw.de
Site Name
Kerckhoff-Klinik GmbH
Department Name
Abt. Administration Forschung und Lehre
Principal Investigator Name
Roland Klingenberg
Principal Investigator Email
r.klingenberg@kerckhoff-klinik.de
Contact Person Name
Roland Klingenberg
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin I
Principal Investigator Name
Paul Christian Schulze
Principal Investigator Email
christian.schulze@med.uni-jena.de
Contact Person Name
Paul Christian Schulze
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Kardiologie und Angiologie
Principal Investigator Name
Tienush Rassaf
Principal Investigator Email
tienush.rassaf@uk-essen.de
Contact Person Name
Tienush Rassaf
Contact Person Email
tienush.rassaf@uk-essen.de

Greece

Earliest CTIS Part Ii Submission Date
08-07-2025
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
295
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Evaggelismos Hospital
Department Name
Department of Cardiology
Principal Investigator Name
Efstathia Prappa
Principal Investigator Email
efiprappa@gmail.com
Contact Person Name
Efstathia Prappa
Contact Person Email
efiprappa@gmail.com
Site Name
Hippokration Hospital
Department Name
First Cardiology Department of the National and Kapodistrian University of Athens
Principal Investigator Name
Charalambos Vlachopoulos
Principal Investigator Email
cvlachop@otenet.gr
Contact Person Name
Charalambos Vlachopoulos
Contact Person Email
cvlachop@otenet.gr
Site Name
University General Hospital Attikon
Department Name
2nd Cardiology University Department
Principal Investigator Name
Gerasimos Filippatos
Principal Investigator Email
gfilippatos@gmail.com
Contact Person Name
Gerasimos Filippatos
Contact Person Email
gfilippatos@gmail.com
Site Name
Onassis Cardiac Surgery Center
Department Name
Unit of Inherited and Rare Cardiovascular Diseases
Principal Investigator Name
Aristidis Anastasakis
Principal Investigator Email
anastasakis@ocsc.gr
Contact Person Name
Aristidis Anastasakis
Contact Person Email
anastasakis@ocsc.gr

Sponsor

Primary sponsor

Full Name
Cytokinetics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Biomarkers, PK, serum and plasma storage – sample collections and central storage, heart rhythm monitoring data analysis; other trial support roles (multiple sponsor duties listed).

Third parties

  • {"country":"United States","full_name":"Celerion Inc.","duties_or_roles":"PK analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"TIMP-1 and ST2 fibrosis biomarkers","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Primevigilance USA Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG analysis/review, LV strain analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"The Brigham And Women’s Hospital Inc.","duties_or_roles":"Echocardiography and analysis","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Roles including Biomarkers, PK, serum and plasma storage – sample collections and central storage, heart rhythm monitoring data analysis (multiple sponsor duties listed)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Mycardium AI Limited","duties_or_roles":"Cardiovascular magnetic resonance image analysis","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Aficamten
Active Substance
Aficamten
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorized
Maximum Dose
20 mg

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