MedTrace Logo

Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

NCT03470545 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2021-10-04

Study results available
· View outcomes & findings →

Summary

This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will be randomized to receive placebo or mavacamten.

Conditions

Interventions

DRUG

mavacamten

mavacamten capsules

DRUG

Placebo

placebo oral capsule

Sponsors & Collaborators

  • MyoKardia, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Information Team · MyoKardia, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2020-03-14
Completion
2020-05-06
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03470545 on ClinicalTrials.gov