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NCT05582395 · ClinicalTrials.gov registry record · Phase 3
A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 580
- Enrollment target
NCT05582395: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT05582395 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 580 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05582395, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 580 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
Primary Outcome
The KCCQ-23 is a 23-item, self-administered questionnaire that measures the impact of a participant's cardiovascular disease or its treatment on 6 distinct domains using a 2-week recall period: symptoms/signs, physical limitation, quality of life (QoL), social limitations, self-efficacy, and symptom stability. The KCCQ 23 Clinical Summary Score (CSS) is derived from the Total Symptom Score (TSS) and the Physical Limitations (PL) score of the KCCQ 23. The CSS, TSS, and the PL score range from 0 t
Interventions
- OTHER Placebo
- DRUG Mavacamten
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 580 participants |
| Start Date | 2022-12-14 |
| Est. Completion | 2025-10-20 |
| Phase | Phase 3 |
What the finished NCT05582395 record still lists
NCT05582395 is an interventional study that assigns participants to a tested intervention. The registered 580 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05582395 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05582395 about?
NCT05582395 is a clinical study titled "A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy". The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
What is the current status of trial NCT05582395?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 580 participants. The study started on 2022-12-14. Estimated completion is 2025-10-20.
What interventions are being tested in trial NCT05582395?
The interventions under investigation include: Placebo (OTHER), Mavacamten (DRUG).
Who is sponsoring clinical trial NCT05582395?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05582395's enrollment target sits among peer trials
580 656th of 2000 higher than 1,342 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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