Status:
COMPLETED
v4 Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Heart Failure With Reduced Ejection Fraction
Dilated Cardiomyopathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this Phase 1b/2a study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MYK-491 in patients with stable heart failure.
Eligibility Criteria
Inclusion
- Key
- Has stable chronic heart failure with reduced ejection fraction
- Has adequate acoustic windows for echocardiography
- Key
Exclusion
- Any significant structural cardiac abnormalities on Screening TTE
- At Screening, symptomatic hypotension or hypertension or bradycardia.
- Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, vasodilators \[e.g., nesiritide\], diuretics) or routinely scheduled ultrafiltration.
- Presence of protocol specified laboratory abnormalities at Screening.
Key Trial Info
Start Date :
February 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2019
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03447990
Start Date
February 6 2018
End Date
October 24 2019
Last Update
February 2 2023
Active Locations (17)
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1
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
2
Prism Reseach
Saint Paul, Minnesota, United States, 55102
3
St. Louis Heart and Vascular Cardiology
St Louis, Missouri, United States, 63136
4
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112