Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03496168
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).

Key Dates

Start date
Apr 26, 2018
Status verified
Jan 2025
Primary completion
Nov 9, 2023
Completion
Nov 9, 2023

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: mavacamten (MYK-461)

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events and Treatment Emergent Serious Adverse Events [ Time Frame: From first dose to end of treatment + 56 days (Approximately an average of 240 Weeks) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Local Institution - 0003ScottsdaleArizona85259-
Local Institution - 0001New HavenConnecticut06520-8017-
Local Institution - 0004DurhamNorth Carolina27710-
Local Institution - 0002PortlandOregon97239-

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By research site
Local Institution - 0003· Scottsdale, AZLocal Institution - 0001· New Haven, CTLocal Institution - 0004· Durham, NCLocal Institution - 0002· Portland, OR

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