RecruitingPhase 2Phase 3NCT06412666

A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).

A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled and Open-Label Extension Trial to Evaluate the Efficacy and Safety of Aficamten in a Pediatric Population With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Sponsor

Cytokinetics

Enrollment

55 participants

Start Date

May 29, 2024

Study Type

INTERVENTIONAL

Conditions

Pediatric Symptomatic Obstructive Hypertrophic Cardiomyopathy

Summary

The purpose of this study is to evaluate the efficacy, safety and PK of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Eligibility

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Aficamten and a drug called Placebo for people with pediatric and symptomatic obstructive hypertrophic cardiomyopathy. The study is currently recruiting participants at 38 locations. People eligible for this study include aged 12 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAficamten

Oral Tablet

DRUGPlacebo

Oral Tablet

Locations(38)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

University of California, Los Angeles (UCLA)

Los Angeles, California, United States

UCSF Benioff Children's Hospital

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Children's National Hospital

Washington D.C., District of Columbia, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

Children's Hospital New Orleans

New Orleans, Louisiana, United States

University of Michigan

Ann Arbor, Michigan, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Morristown Medical Center

Morristown, New Jersey, United States

NYP/Columbia University Medical Center

New York, New York, United States

Children's Hospital at Montefiore

The Bronx, New York, United States

Duke Clinical Research Institute

Durham, North Carolina, United States

Oregon Health & Science University

Portland, Oregon, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

LeBonheur Children's Hospital

Memphis, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Dell Children's Hospital

Austin, Texas, United States

UT Southwestern

Dallas, Texas, United States

Children's Wisconsin

Milwaukee, Wisconsin, United States

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, Italy

NHO Kagoshima Medical Center

Kagoshima, Japan

University of Osaka Hospital

Osaka, Japan

Kitasato University Hospital

Sagamihara, Japan

National Cerebral and Cardiovascular Center

Suita, Japan

Juntendo University Hospital

Tokyo, Japan

Unidad de Cardiología Infantil; Hospital Universitario da Coruña

A Coruña, Spain

Hospital Sant Joan de Deu

Barcelona, Spain

Alder Hey Children's Hospital

Liverpool, United Kingdom

Evelina Children's Hospital

London, United Kingdom

Great Ormond Street Hospital for Children

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06412666

Related Trials

Quantifying Motor Network Dynamics to Predict and Enhance Outcomes in Pediatric Dystonia

NCT073251751 location

The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Children: A Biased-Coin Dose-Finding Trial

NCT076974041 location

Use of the Single Port Robotic System in Pediatric Surgery

NCT076604971 location

External Oblique Intercostal Plane Block Versus Erector Spinae Plane Block in Paediatric Upper Abdominal Surgeries

NCT076175451 location

Intratumoral DNX-2401 for High Grade Pediatric Brain Tumors

NCT074240922 locations