A Phase 2 interventional study of mavacamten and Placebo in Non-obstructive Hypertrophic Cardiomyopathy, sponsored by MyoKardia, Inc.. Completed at 32 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by MyoKardia, Inc. (part of Bristol-Myers Squibb) · Phase 2, Interventional, and Treatment
Among 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic — 3 open to participants now, 7 under way, 1 of them phase 3. MYK-461 · Cardiomyopathy, Hypertrophic.
Among the 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic, this one is the 13th largest by enrollment, is one of 4 that started in 2018, is one of 3 in phase 2, and was the 4th registered.
363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.
Browse Cardiomyopathy, Hypertrophic studies →3 of the 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic are open now, in 2 countries. Recruiting first, the newest first:
University of Manchester · Sites in United Kingdom
Ages 18+
Second Affiliated Hospital, Zhejiang University, School of Medicine · Sites in China
Ages 18–75
Second Affiliated Hospital of Nanchang University
Ages 18+
By country, each count listing its studies:
MYK-461: first FDA approval 2022 (CAMZYOS), first EMA approval 2023. What it is approved for, and how studies give it, is on its page →
Of the 81 Cardiomyopathy, Hypertrophic studies recruiting now, 55 (68%) set no upper age limit and 8 (10%) stop at 75 or younger; 21 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 4 · Phase 3 7 · Phase 4 4
First in 2014; this study’s year is marked. 4 started in 2018.
This study's enrollment of 59 is close to the median of 60 across 180 interventional studies indexed under Cardiomyopathy, Hypertrophic.
Median enrollment 75 across the 21 interventional studies. Of the 14 that completed or were terminated, 9 (64%) have results posted.
This tab as a report to print or save as PDF → With an account.
17 of 21 have an industry lead sponsor. The 7 most frequent:
This study is registered under MyoKardia, Inc., one of the names counted as Bristol-Myers Squibb. Under that name alone:
MyoKardia, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
31 studies in Cardiomyopathy, Hypertrophic by Bristol-Myers Squibb: 9 open now, 14 under way, 1 of them phase 3. Of 17 finished, 8 (47%) have results posted.
Among the 31 studies in Cardiomyopathy, Hypertrophic by Bristol-Myers Squibb, this one is the 8th largest by enrollment of the 16 interventional ones that give a count, is one of 4 that started in 2018, is one of 4 in phase 2, and was the 4th registered.
Bristol-Myers Squibb’s Cardiomyopathy, Hypertrophic studies by the year they started, since 2014.
None of the studies under way reaches primary completion within a year.
Among the 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic, from their registry updates:
Among Bristol-Myers Squibb’s 31 in Cardiomyopathy, Hypertrophic:
This tab as a report to print or save as PDF → With an account.
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active Treatment for participants with base target trough concentration
Drug: mavacamten
Active Treatment for participants with higher target trough concentration
Drug: mavacamten
Placebo Group
Drug: Placebo
MYK-461
Also known as: MYK-461
Placebo
Percentage of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)
This is the percentage of participants who experienced at least one treatment emergent adverse event (TEAE)
Time frame: From first dose to 8 weeks following last dose (Up to 24 weeks)
Percentage of Participants Who Experienced at Least One Serious Treatment-emergent Adverse Event (STEAE)
This is the percentage of participants who experienced at least one serious treatment-emergent adverse event (STEAE)
Time frame: From first dose to 8 weeks following last dose (Up to 24 weeks)
In total, 157 participants were assessed for eligibility and 59 were enrolled from 35 sites in the United States.
| Milestone | Group 1 | Group 2 | Placebo |
|---|---|---|---|
| Started | 19 | 21 | 19 |
| Completed | 18 | 21 | 19 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 |
This is the percentage of participants who experienced at least one treatment emergent adverse event (TEAE)
| percentage of participants | Group 1 | Group 2 | Placebo |
|---|---|---|---|
| Percentage of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE) | 88.9 | 90.5 | 68.4 |
This is the percentage of participants who experienced at least one serious treatment-emergent adverse event (STEAE)
| percentage of participants | Group 1 | Group 2 | Placebo |
|---|---|---|---|
| Percentage of Participants Who Experienced at Least One Serious Treatment-emergent Adverse Event (STEAE) | 11.1 | 9.5 | 21.1 |
Collected over From first dose to 8 weeks following last dose (Up to 24 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 Mavacamten | 0/18 (0%) | 2/18 (11.1%) | 16/18 (88.9%) |
| Group 2 Mavacamten | 0/21 (0%) | 2/21 (9.5%) | 18/21 (85.7%) |
| Combined MAVA Treatment Group (Group 1+ Group 2) | 0/39 (0%) | 4/39 (10.3%) | 34/39 (87.2%) |
| Placebo | 0/19 (0%) | 4/19 (21.1%) | 11/19 (57.9%) |
| Event | Group 1 Mavacamten | Group 2 Mavacamten | Combined MAVA Treatment Group (Group 1+ Group 2) | Placebo |
|---|---|---|---|---|
| Atrial fibrillationCardiac disorders | 0/18 | 2/21 | 2/39 | 1/19 |
| ArthritisMusculoskeletal and connective tissue disorders | 1/18 | 0/21 | 1/39 | 0/19 |
| Mental status changesPsychiatric disorders | 1/18 | 0/21 | 1/39 | 0/19 |
| Renal FailureRenal and urinary disorders | 1/18 | 0/21 | 1/39 | 0/19 |
| Angina pectorisCardiac disorders | 0/18 | 0/21 | 0/39 | 1/19 |
| Atrial FlutterCardiac disorders | 0/18 | 0/21 | 0/39 | 1/19 |
| Coronary artery diseaseCardiac disorders | 0/18 | 0/21 | 0/39 | 1/19 |
| Systolic dysfunctionCardiac disorders | 0/18 | 1/21 | 1/39 | 0/19 |
| Event | Group 1 Mavacamten | Group 2 Mavacamten | Combined MAVA Treatment Group (Group 1+ Group 2) | Placebo |
|---|---|---|---|---|
| PalpitationsCardiac disorders | 1/18 | 5/21 | 6/39 | 3/19 |
| DizzinessNervous system disorders | 3/18 | 4/21 | 7/39 | 1/19 |
| FatigueGeneral disorders | 2/18 | 3/21 | 5/39 | 3/19 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/18 | 3/21 | 4/39 | 3/19 |
| Upper respiratory tract infectionInfections and infestations | 1/18 | 3/21 | 4/39 | 0/19 |
| ConstipationGastrointestinal disorders | 2/18 | 2/21 | 4/39 | 0/19 |
| NauseaGastrointestinal disorders | 2/18 | 2/21 | 4/39 | 2/19 |
| Abdominal distensionGastrointestinal disorders | 2/18 | 0/21 | 2/39 | 0/19 |
| NasopharyngitisInfections and infestations | 2/18 | 2/21 | 4/39 | 2/19 |
| Tooth abscessInfections and infestations | 2/18 | 0/21 | 2/39 | 0/19 |
| Age, Continuous(years) | Group 1 | Group 2 | Placebo | Total |
|---|---|---|---|---|
| Mean | 58.3 ± 13.7 | 50.0 ± 14.7 | 53.8 ± 18.2 | 53.9 ± 15.7 |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Placebo | Total |
|---|---|---|---|---|
| Female | 9 | 12 | 13 | 34 |
| Male | 10 | 9 | 6 | 25 |
| Ethnicity (NIH/OMB)(Participants) | Group 1 | Group 2 | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 3 | 5 |
| Not Hispanic or Latino | 18 | 19 | 15 | 52 |
| Unknown or Not Reported | 1 | 0 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Group 1 | Group 2 | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 0 | 2 |
| White | 17 | 18 | 17 | 52 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 2 | 4 |
| NT-proBNP(ng/L) | Group 1 | Group 2 | Placebo | Total |
|---|---|---|---|---|
| Mean | 1160.7 ± 859.02 | 933.3 ± 719.41 | 1164.1 ± 817.70 | 1080.8 ± 791.97 |
| Troponin-I(participants) | Group 1 | Group 2 | Placebo | Total |
|---|---|---|---|---|
| Elevated | 6 | 7 | 6 | 19 |
| Detectable Not Elevated | 6 | 10 | 5 | 21 |
| Undetectable | 6 | 4 | 8 | 18 |
| Missing | 1 | 0 | 0 | 1 |
| New York Heart Association (NYHA) Functional Classification(Participants) | Group 1 | Group 2 | Placebo | Total |
|---|---|---|---|---|
| Class II | 15 | 18 | 13 | 46 |
| Class III | 4 | 3 | 6 | 13 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Jan 2020, 21 months.
Results were first posted in Aug 2022, 2 years 7 months after primary completion. A results delay was requested in Oct 2020.
Of 20 phase 2 interventional studies under Cardiomyopathy, Hypertrophic, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 43. This study's 21 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: MYK-461
Cardiomyopathy, Hypertrophic →