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NCT03442764 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)
A Phase 2 study of Non-obstructive Hypertrophic Cardiomyopathy, sponsored by MyoKardia.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
- 20
- Study locations
NCT03442764: Completed Phase 2 study of Non-obstructive Hypertrophic Cardiomyopathy, sponsored by MyoKardia.
NCT03442764 is a Phase 2 study of Non-obstructive Hypertrophic Cardiomyopathy that has completed, run by MyoKardia. The registered enrollment target is 59 participants, below the 244-participant average among 3 other Non-obstructive Hypertrophic Cardiomyopathy trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03442764, a Phase 2 study of Non-obstructive Hypertrophic Cardiomyopathy, has completed, sponsored by MyoKardia.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, exploratory, randomized, double-blind study of the administration of mavacamten in 60 participants with symptomatic nHCM randomized to receive a 16-week course of mavacamten doses titrated to achieve 1 of 2 target drug concentrations.
Primary Outcome
This is the percentage of participants who experienced at least one treatment emergent adverse event (TEAE)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG mavacamten
Study Locations (20)
California
- Cedars-Sinai Medical Center (Smidt Heart Institute) - Los Angeles
- Stanford Hospital and Clinics/Stanford University - Palo Alto
- University of California, San Francisco - San Francisco
Michigan
- Michigan Medicine - Ann Arbor
- Henry Ford Hospital - Detroit
New York
- NYU Winthrop Hospital - Mineola
- NYU Langone Medical Center - New York
North Carolina
- Carolinas Medical Center - Charlotte
- Duke Cardiology at Southpoint - Durham
Arizona
- Mayo Clinic Arizona - Scottsdale
Connecticut
- Yale New Haven Hospital - New Haven
Illinois
- Northwestern University - Evanston
Indiana
- St. Vincent Medical Group - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2018-03-30 |
| Est. Completion | 2020-01-07 |
| Phase | Phase 2 |
What the finished NCT03442764 record still lists
NCT03442764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 244-participant average among 3 other Non-obstructive Hypertrophic Cardiomyopathy trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Non-obstructive Hypertrophic Cardiomyopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03442764 names 20 study sites across 15 states, led by California, Michigan, New York.
Frequently Asked Questions
What is clinical trial NCT03442764 about?
NCT03442764 is a clinical study titled "A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)". This is a multicenter, exploratory, randomized, double-blind study of the administration of mavacamten in 60 participants with symptomatic nHCM randomized to receive a 16-week course of mavacamten doses titrated to achieve 1 of 2 target drug concentrations.
What is the current status of trial NCT03442764?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2018-03-30. Estimated completion is 2020-01-07.
What conditions does trial NCT03442764 study?
This clinical trial studies the following conditions: Non-obstructive Hypertrophic Cardiomyopathy.
What interventions are being tested in trial NCT03442764?
The interventions under investigation include: Placebo (DRUG), mavacamten (DRUG).
Who is sponsoring clinical trial NCT03442764?
This trial is sponsored by MyoKardia, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03442764 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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