ClinicalTrials.Veeva

Menu

A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling
Phase 3

Conditions

Cardiomyopathy, Hypertrophic

Treatments

Drug: Placebo
Drug: Mavacamten

Study type

Interventional

Funder types

Industry

Identifiers

NCT06253221
2023-505650-17-00 (Other Identifier)
CV027-010
U1111-1290-1175 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

Enrollment

40 estimated patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of HCM
  • Presence of LVOT obstruction
  • Presence of symptoms

Exclusion criteria

  • Phenocopy diseases resulting in myocardial hypertrophy not related to sarcomere dysfunction
  • Evidence of LVEF <50% in prior 6 months
  • Planned escalation in HCM therapy or upcoming intervention (eg, major cardiac surgery, HCM medication dose increase)

Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups

Mavacamten
Experimental group
Description:
Participants assigned to this arm will receive mavacamten (1 mg to 15 mg) from day 1 to end of treatment at week 200.
Treatment:
Drug: Mavacamten
Placebo
Experimental group
Description:
Participants assigned to this arm will receive mavacamten (1 mg to 15 mg) from week 28 to end of treatment at week 200.
Treatment:
Drug: Placebo

Trial contacts and locations

55

Loading...

Central trial contact

BMS Study Connect Contact Center www.BMSStudyConnect.com; First line of the email MUST contain the NCT# and Site #.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems