Trial · NCT03496168
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
NCT03496168, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2025-01-09
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER. Trials, record NCT03496168. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03496168
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
- NCT number
- NCT03496168
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Hypertrophic Cardiomyopathy
- Interventions
- mavacamten
- First posted
- 2018-04-12
- Last updated
- 2025-01-09
- Results first posted
- 2025-01-09
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events and Treatment Emergent Serious Adverse Events | From first dose to end of treatment + 56 days (Approximately an average of 240 Weeks) | AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that: * Results in death * Is immediately life-threatening (places the participant at immediate risk of death from the event as it occurred) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions * Results in a congenital abnormality or birth defect * Is an important medical event that may not result in death, be life- threatening, or require hospitalization, but may be considered an SAE when, based upon appropriate medical judgment, it may require medical or surgical intervention to prevent any of the outcomes listed above. |
| Primary | Number of Participants Who Had Cardiovascular Death | From first dose to end of study, (approximately 260 weeks) | Number of participants who had died due to cardiovascular reasons. |
| Primary | Number of Participants Who Experienced Sudden Death | From first dose to end of study, (approximately 260 weeks) | Number of participants who experienced sudden death |
| Primary | Number of Participants Who Were Hospitalized for Cardiovascular Reasons. | From first dose to end of study, (approximately 260 weeks) | Number of participants who were hospitalized for cardiovascular reasons. |
| Primary | Number of Participants With Heart Failure Due to Systolic Dysfunction, Defined as Asymptomatic LVEF < 50% | From first dose to end of study, (approximately 260 weeks) | Number of participants with heart failure due to systolic dysfunction, defined as asymptomatic LVEF \< 50% |
| Primary | Number of Participants With LVEF < 50% as Measured by Echocardiography. | From first dose to end of study, (approximately 260 weeks) | Number of participants with LVEF \< 50% as measured by echocardiography. |
| Primary | Number of Participants Who Were Experienced Myocardial Infarction | From first dose to end of study, (approximately 260 weeks) | Number of participants who experienced myocardial infarction. |
| Primary | Number of Participants With Ventricular Arrhythmias. | From first dose to end of study, (approximately 260 weeks) | Types of Ventricular Arrhythmias measured in this endpoint will be: Ventricular Tachycardia Ventricular Fibrilation Ventricular Flutter |
| Primary | Number of Participants Who Experienced Syncope | From first dose to end of study, (approximately 260 weeks) | Number of participants who experienced syncope. Syncope will be defined as participants who experienced dizziness or orthostatic hypotension. |
| Primary | Number of Participants Who Experienced Seizures | From first dose to end of study, (approximately 260 weeks) | Number of participants who were experienced seizures. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events and Treatment Emergent Serious Adverse Events | From first dose to end of treatment + 56 days (Approximately an average of 240 Weeks) | All Treated Participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Had Cardiovascular Death | From first dose to end of study, (approximately 260 weeks) | All Treated Participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced Sudden Death | From first dose to end of study, (approximately 260 weeks) | All Treated Participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Were Hospitalized for Cardiovascular Reasons. | From first dose to end of study, (approximately 260 weeks) | All Treated Participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Heart Failure Due to Systolic Dysfunction, Defined as Asymptomatic LVEF < 50% | From first dose to end of study, (approximately 260 weeks) | All Treated Participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With LVEF < 50% as Measured by Echocardiography. | From first dose to end of study, (approximately 260 weeks) | All Treated Participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Were Experienced Myocardial Infarction | From first dose to end of study, (approximately 260 weeks) | All Treated Participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Ventricular Arrhythmias. | From first dose to end of study, (approximately 260 weeks) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced Syncope | From first dose to end of study, (approximately 260 weeks) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced Seizures | From first dose to end of study, (approximately 260 weeks) | All Treated Participants | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group137
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events and Treatment Emergent Serious Adverse Events | Mavacamtem | TEAEs | 13 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events and Treatment Emergent Serious Adverse Events | Mavacamtem | TESAEs | 5 | Participants | |
| Number of Participants Who Had Cardiovascular Death | Mavacamtem | 0 | Participants | ||
| Number of Participants Who Experienced Sudden Death | Mavacamtem | 0 | Participants | ||
| Number of Participants Who Were Hospitalized for Cardiovascular Reasons. | Mavacamtem | 1 | Participants | ||
| Number of Participants With Heart Failure Due to Systolic Dysfunction, Defined as Asymptomatic LVEF < 50% | Mavacamtem | 0 | Participants | ||
| Number of Participants With LVEF < 50% as Measured by Echocardiography. | Mavacamtem | 2 | Participants | ||
| Number of Participants Who Were Experienced Myocardial Infarction | Mavacamtem | 0 | Participants | ||
| Number of Participants With Ventricular Arrhythmias. | Mavacamtem | Ventricular Tachycardia | 1 | Participants | |
| Number of Participants With Ventricular Arrhythmias. | Mavacamtem | Ventricular Fibrilation | 0 | Participants |
1 to 10 of 137Source ClinicalTrials.gov
See all 137 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mavacamtem | 13 | |
| Overall Study | COMPLETED | Mavacamtem | 11 | |
| Overall Study | NOT COMPLETED | Mavacamtem | 2 |
Source ClinicalTrials.gov
Adverse events110
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukocytosis | Blood and lymphatic system disorders | Mavacamten | 1 | 13 | |
| other | Atrial fibrillation | Cardiac disorders | Mavacamten | 1 | 13 | |
| other | Cardiac flutter | Cardiac disorders | Mavacamten | 1 | 13 | |
| other | Mitral valve incompetence | Cardiac disorders | Mavacamten | 1 | 13 | |
| other | Palpitations | Cardiac disorders | Mavacamten | 1 | 13 | |
| other | Supraventricular tachycardia | Cardiac disorders | Mavacamten | 1 | 13 | |
| other | Ventricular tachycardia | Cardiac disorders | Mavacamten | 1 | 13 | |
| other | Tinnitus | Ear and labyrinth disorders | Mavacamten | 1 | 13 | |
| other | Thyroid mass | Endocrine disorders | Mavacamten | 1 | 13 | |
| other | Eyelid ptosis | Eye disorders | Mavacamten | 1 | 13 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mavacamten | 0 | 13 |
| Total, other adverse events | Mavacamten | 13 | 13 |
| Total, serious adverse events | Mavacamten | 5 | 13 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38591260 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03496168
GET https://conductscience.org/api/trials/v1/NCT03496168/results?page=2