A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM

Sponsor
LianBio LLC
Study ID
NCT05174416
Phase
PHASE3
Status
Completed

Conditions

  • Obstructive Hypertrophic Cardiomyopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Mavacamten — DRUG
    Mavacamten Capsules
  • Placebo — DRUG
    Matching PBO capsules during placebo controlled period，and mavacamten capsules during long term extension period

Study Details

Mavacamtenis a novel, small molecule, selective allosteric inhibitor of cardiac-specific myosin, for the treatment of patients with symptomatic oHCM. This study will assess the efficacy and safety of mavacamten in Chinese adults with symptomatic oHCM.

Key Dates

Start date
Jan 4, 2022
Status verified
Sep 2024
Primary completion
Mar 6, 2023
Completion
Jul 22, 2024

Study Design

Enrollment
81 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mavacamten
    Mavacamten Capsules
  • Placebo Comparator: placebo
    Matching Placebo Capsules

Primary Outcome Measure

Change From Baseline to Week 30 in Valsalva Left Ventricular Outflow Tract (LVOT) Peak Gradient [ Time Frame: 30 weeks ]

Related Studies