Clinical Trial: A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 2 Open-label Pilot Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyo

Brief Summary: The purpose of this phase 2 open-label pilot study is to evaluate the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of MYK-461 in subjects with symptomatic HCM and LVOT obstruction aged 18-70 years.

Detailed Summary:
Sponsor: MyoKardia, Inc.

Current Primary Outcome: Change in post-exercise peak LVOT gradient from baseline to Week 12 [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: MyoKardia, Inc.

Dates:
Date Received: July 20, 2016
Date Started: August 2016
Date Completion: March 2018
Last Updated: May 11, 2017
Last Verified: May 2017