Other Clinical Trial - A Phase 2 Open-label Pilot Study Evaluating MYK-461

A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction — PIONEER-HCM

Cardiomyopathy, Hypertrophic Obstructive Clinical Trial

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 Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Cardiomyopathies
Cardiomyopathy, Hypertrophic
Cardiomyopathy, Hypertrophic Obstructive
Hypertrophy
Left Ventricular Outflow Tract Obstruction

See also
Status	Clinical Trial	Phase
Terminated	`NCT04418297` - A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy	Phase 1
Recruiting	`NCT06391788` - Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy	N/A
Active, not recruiting	`NCT05414175` - A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy	Phase 3

See also

Status

Clinical Trial

Phase

Terminated

NCT04418297 - A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy

Phase 1

Recruiting

NCT06391788 - Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy

N/A

Active, not recruiting

NCT05414175 - A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy

Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02842242
Study type	Interventional
Source	MyoKardia, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	August 2016
Completion date	November 2017

A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction — PIONEER-HCM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms