Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04349072 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 112
- Enrollment target
NCT04349072: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT04349072 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 112 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04349072, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 112 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures performed in subjects with symptomatic obstructive hypertrophic cardiomyopathy (oHCM \[also known as HOCM\]) who are eligible for SRT based on ACCF/AHA 2011 and/or ESC 2014 guidelines.
Primary Outcome
Participants who decided to proceed with SRT or were eligible for SRT at week 16. Participants with missing assessments were classified as meeting the primary endpoint (did not improve). SRT eligibility using the New York Heart Association Functional Class (NYHA) and left ventricular outflow tract (LVOT) assessments per the 2011 ACCF/AHA guideline clinical and hemodynamic criterion are below: * NYHA Class III or IV/ NYHA Class II with exertion-induced syncope/near syncope, AND * Dynamic LVOT g
Interventions
- DRUG Placebo
- DRUG Mavacamten
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2020-07-06 |
| Est. Completion | 2024-05-20 |
| Phase | Phase 3 |
What the finished NCT04349072 record still lists
NCT04349072 is an interventional study that assigns participants to a tested intervention. The registered 112 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 (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04349072 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04349072 about?
NCT04349072 is a clinical study titled "A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy". This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures performed in subjects with symptomatic obstructive hypertrophic cardiomyopa...
What is the current status of trial NCT04349072?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2020-07-06. Estimated completion is 2024-05-20.
What interventions are being tested in trial NCT04349072?
The interventions under investigation include: Placebo (DRUG), Mavacamten (DRUG).
Who is sponsoring clinical trial NCT04349072?
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 NCT04349072's enrollment target sits among peer trials
112 1652nd of 2000 higher than 346 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04511013 · 112 participants · Phase 2
A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
- NCT04551560 · 112 participants · NA
Stress and Congestive Heart Failure
- NCT04872166 · 112 participants · Phase 1
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
- NCT05024773 · 112 participants · Phase 3
Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI