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NCT03470545 · ClinicalTrials.gov registry record · Phase 3
Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
A Phase 3 study, sponsored by MyoKardia.
- Completed
- Registry status
- Phase 3
- Development phase
- 251
- Enrollment target
NCT03470545: Completed Phase 3 study, sponsored by MyoKardia.
NCT03470545 is a Phase 3 study that has completed, run by MyoKardia. The registered enrollment target is 251 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03470545, a Phase 3 study, has completed, sponsored by MyoKardia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 251 participants
- Enrollment target
Study Summary
This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will be randomized to receive placebo or mavacamten.
Primary Outcome
A positive clinical response (value="YES") is defined as having achieved either an improvement of at least 1.5 mL/kg/min in peak oxygen consumption (pVO2) as determined by cardiopulmonary exercise testing (CPET) and a reduction of one or more class in New York Heart Association (NYHA) functional classification (e.g.I, II, III, or IV) -OR- an improvement of 3.0 mL/kg/min or more in pVO2 with no worsening in NYHA Functional Class.
Interventions
- DRUG Placebo
- DRUG mavacamten
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2018-05-29 |
| Est. Completion | 2020-05-06 |
| Phase | Phase 3 |
What the finished NCT03470545 record still lists
NCT03470545 is an interventional study that assigns participants to a tested intervention. The registered 251 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 (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03470545 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03470545 about?
NCT03470545 is a clinical study titled "Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy". This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will be randomized to receive placebo or mavacamten.
What is the current status of trial NCT03470545?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 251 participants. The study started on 2018-05-29. Estimated completion is 2020-05-06.
What interventions are being tested in trial NCT03470545?
The interventions under investigation include: Placebo (DRUG), mavacamten (DRUG).
Who is sponsoring clinical trial NCT03470545?
This trial is sponsored by MyoKardia, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03470545's enrollment target sits among peer trials
251 1249th of 2000 higher than 752 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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