NCT06122779
Recruiting
Phase 2
A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Overview
- Phase
- Phase 2
- Intervention
- BMS-986435
- Conditions
- Heart Failure
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 208
- Locations
- 117
- Primary Endpoint
- Incidence of treatment emergent adverse events (TEAEs)
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BMS-986435
Intervention: BMS-986435
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence of treatment emergent adverse events (TEAEs)
Time Frame: Up to approximately 24 weeks
Incidence of serious adverse events (SAEs)
Time Frame: Up to approximately 24 weeks
Incidence of AEs leading to treatment discontinuation
Time Frame: Up to approximately 20 weeks
Secondary Outcomes
- Summary of plasma concentrations of MYK-224(Up to approximately 20 weeks)
Study Sites (117)
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