Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM

PHASE3CompletedINTERVENTIONAL
Enrollment

175

Participants

Timeline

Start Date

June 20, 2023

Primary Completion Date

February 28, 2025

Study Completion Date

March 28, 2025

Conditions
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Interventions
DRUG

Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg)

Aficamten (CK-3773274) tablets administered orally

DRUG

Placebo to match aficamten

Placebo for aficamten (CK-3773274) administered orally

DRUG

Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg)

Metoprolol succinate tablets administered orally

DRUG

Placebo to match metoprolol succinate

Placebo for metoprolol succinate administered orally

Trial Locations (71)

10032

Columbia University Medical Center/New York Presbyterian Hospital, New York

19104

Division of Heart Failure and Transplantation (Hospital of the University of Pennsylvania), Philadelphia

22042

Inova Schar Heart and Vascular, Falls Church

27560

Duke Health Center Arringdon, Morrisville

28204

Sanger Heart & Vascular Institute - HCM Clinic, Charlotte

29425

Medical University of South Carolina, Charleston

30214

Piedmont Fayette Hospital, Fayetteville

30322

Emory Clinic, Atlanta

32804

AdventHealth, Orlando

37205

Ascension Saint Thomas Heart West, Nashville

37232

Vanderbilt University Medical Center, Nashville

48202

Henry Ford Hospital, Detroit

60208

Northwestern University, Evanston

64111

Saint Luke's Hospital of Kansas City, Kansas City

77030

CHI St. Luke's Health Baylor-St. Luke's Medical Center, Houston

Houston Methodist Hospital, Houston

84107

Intermountain Medical Center, Murray

85054

Mayo Clinic, Phoenix

90048

Cedars-Sinai Medical Center (Smidt Heart Institute), Los Angeles

92037

UC San Diego Health - Sulpizio Cardiovascular Center, La Jolla

97225

Providence St. Vincent Medical Center, Portland

97239

Oregon Health & Science University, Portland

99508

Alaska Heart and Vascular Institute, Anchorage

510080

The First Affiliated Hospital, Sun Yat-sen University, Guangzhou

06519

Yale New Haven Hospital, New Haven

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

01803

Lahey Hospital & Medical Center, Burlington

07960

Morristown Medical Center, Morristown

04012-909

Institutdo Danta Pazzanese, Ibirapuera

13060-080

Instituto de Pesquisa Clinica de Campinas - IPECC, Campinas

05403-900

lnstituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo

Unknown

Institut universitaire de cardiologie et de pneumonlogie de Quebec - Universite Laval, Québec

Xiangya Second Hospital of Central South University, Changsha

Guangdong Provincial People's Hospital, Guangzhou

Zhongshan Hospital Fudan University, Shanghai

Renmin Hospital of Wuhan University, Wuhan

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

Aarhus University Hospital, Aarhus

Copenhagen University Hospital, Copenhagen

CHU La Timone, Marseille

Hopital Europeen Georges Pompidou, Paris

Hopital Lariboisiere - APHP, Paris

Hopital Cardiologique Haut Leveque - CHU de Bordeaux, Pessac

CHU Pontchaillou, Rennes

Hopital Laennec - CHU de Nantes, Saint-Herblain

Charite-Universitatsmedizin Berlin - Campus Virchow Klinikum, Berlin

Universitaetsklinikum Essen, Essen

Universitaetsklinikum Jena, Jena

Semmelweis Egyetem, Városmajori Szív- és Érgyógyászati Klinika, Budapest

Barzilai Medical Center, Ashkelon

Hadassah Hebrew Medical Center- Ein Kerem, Jerusalem

The Chaim Sheba Medical Center, Ramat Gan

Kaplan Medical Center, Rehovot

Ziv Medical Center, Safed

AOU Careggi, Florence

Erasmus Medical Center, Rotterdam

Complejo Hospitalario Universitario A Coruna, A Coruña

Hospital Clinic de Barcelona, Barcelona

Hospital Clinico Universitario Virgen Arrixaca, El Palmar

Hospital Universitario Puerta de Hierro, Madrid

Hospital Universitario de Salamanca, Salamanca

Hospital Universitario Virgen del Rocio, Seville

Hospital Universitario Virgen Macarena, Seville

Hospital Universitario Son Llatzer, Son Ferriol

NHS Greater Glasgow and Clyde, Glasgow

Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool

Barts Health NHS Trust, London

Royal Brompton Hospital, London

St George's University Hospitals NHS Foundation Trust, London

Oxford University Hospital NHS Trust - John Radcliffe Hospital - OCMR, Oxford

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Cytokinetics

INDUSTRY

NCT05767346 - Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM | Biotech Hunter | Biotech Hunter