A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04349072
Phase
PHASE3
Status
Completed

Conditions

  • HOCM, Hypertrophic Obstructive Cardiomyopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mavacamten — DRUG
    Mavacamten Capsules Other names: MYK-461
  • Placebo — DRUG
    Placebo

Study Details

This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures performed in subjects with symptomatic obstructive hypertrophic cardiomyopathy (oHCM \[also known as HOCM\]) who are eligible for SRT based on ACCF/AHA 2011 and/or ESC 2014 guidelines.

Key Dates

Start date
Jul 6, 2020
Status verified
May 2025
Primary completion
Feb 7, 2022
Completion
May 20, 2024

Study Design

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

Arms

  • Experimental: Drug: Mavacamten
    Mavacamten Capsules Other names: MYK-461
  • Placebo Comparator: Drug: Placebo
    Matching Placebo Capsules

Primary Outcome Measure

Composite of Decision to Proceed With Septal Reduction Therapy (SRT) and SRT Guideline Eligible at Week 16 [ Time Frame: Week 16 ]

Locations (21)

FacilityCityStateZIPSite coordinators
Local Institution - 0009Los AngelesCalifornia90027-
Local Institution - 0011StanfordCalifornia94305 5406-
Local Institution - 0001New HavenConnecticut06520-
Local Institution - 0021WestonFlorida33331-
Local Institution - 0007BostonMassachusetts02115-
Local Institution - 0016BostonMassachusetts02114-2696-
Local Institution - 0006Ann ArborMichigan48109-
Local Institution - 0013Grand RapidsMichigan49503-
Local Institution - 0015RochesterMinnesota55905-
Local Institution - 0005St LouisMissouri63110-
Local Institution - 0010New YorkNew York10016-
Local Institution - 0017ValhallaNew York10595-
Local Institution - 0004DurhamNorth Carolina27710-
Local Institution - 0020ClevelandOhio44195-
Local Institution - 0002PortlandOregon97239-
Local Institution - 0003PhiladelphiaPennsylvania19104-
Local Institution - 0019PittsburghPennsylvania15212-
Local Institution - 0014NashvilleTennessee37205-
Local Institution - 0018NashvilleTennessee37235-
Local InstitutionHoustonTexas77030-
Local Institution - 0012MurrayUtah84107-5701-

Find similar trials in Los Angeles, CA

By research site
Local Institution - 0009· Los Angeles, CALocal Institution - 0011· Stanford, CALocal Institution - 0001· New Haven, CTLocal Institution - 0021· Weston, FLLocal Institution - 0007· Boston, MALocal Institution - 0016· Boston, MA