Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412666
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-09
Brief Title:
A Study to Evaluate the Effect of Aficamten in Pediatric Patients Age 12 to 18 Years With Symptomatic Obstructive Hypertrophic Cardiomyopathy oHCM
Sponsor:
Cytokinetics
Organization:
Cytokinetics
Study Overview
Official Title:
A Phase 23 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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CEDAR-HCM
Brief 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
Detailed Description:
The overall objective of the trial is to determine the efficacy safety and tolerability of administration of aficamten in adolescents 12 to 18 years old and children 6 to 12 years old with symptomatic oHCM Adolescents and children will be studied in a staged approach involving established favorable pharmacodynamic and safety profiles of aficamten in adolescents followed by further pharmacokinetic modeling to inform the dosing regimen in children
The trial will consist of 2 periods
1 Period 1 is the randomized double-blind placebo-controlled treatment period that will assess the efficacy safety and tolerability of aficamten in pediatric participants Duration approximately 12 weeks
2 Period 2 is the open-label extension trial that will assess the long-term safety of aficamten in pediatric participants and further assess efficacy and tolerability Duration approximately 52 weeks
The trial will consist of 2 periods
1 Period 1 is the randomized double-blind placebo-controlled treatment period that will assess the efficacy safety and tolerability of aficamten in pediatric participants Duration approximately 12 weeks
2 Period 2 is the open-label extension trial that will assess the long-term safety of aficamten in pediatric participants and further assess efficacy and tolerability Duration approximately 52 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-511377-30-00 | CTIS | None | None |