Trial · NCT05174416
A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM
NCT05174416, Phase 3, Completed, LianBio LLC; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM. Trials, record NCT05174416. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05174416
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM
- NCT number
- NCT05174416
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 81 participants, actual
- Lead sponsor
- LianBio LLC
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Interventions
- Mavacamten, Placebo
- First posted
- 2021-12-30
- Last updated
- 2024-09-19
- Results first posted
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 30 in Valsalva Left Ventricular Outflow Tract (LVOT) Peak Gradient | 30 weeks | To compare the effect of a 30-week course of mavacamten with placebo on Valsalva LVOT peak gradient as determined by Doppler echocardiography |
| Secondary | Change From Baseline to Week 30 in Resting LVOT Peak Gradient | 30 weeks | To compare the effect of a 30-week course of mavacamten with placebo on LVOT obstruction. |
| Secondary | Proportion of Participants Achieving a Valsalva LVOT Peak Gradient < 30 mmHg at Week 30 | 30 weeks | To compare the effect of a 30-week course of mavacamten with placebo on LVOT obstruction. |
| Secondary | Proportion of Participants Achieving a Valsalva LVOT Peak Gradient < 50 mmHg at Week 30. | 30 weeks | To compare the effect of a 30-week course of mavacamten with placebo on LVOT obstruction. |
| Secondary | Proportion of Participants With at Least 1 Class Improvement in New York Heart Association (NYHA) Functional Classification From Baseline to Week 30 | 30 weeks | To compare the effect of a 30-week course of mavacamten with placebo on clinical symptoms |
| Secondary | Change From Baseline to Week 30 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) | 30 weeks | To compare the effect of a 30-week course of Mavacamten with placebo on Participant-Reported health status individually The KCCQ (23-item version) is a patient-reported questionnaire that measures the impact of patients' CV disease or its treatment on 6 distinct domains using a 2-week recall: symptoms/signs, physical limitations, quality of life, social limitations, self-efficacy, and symptom stability (Green et al., 2000). In addition to the individual domains, 2 summary scores can be calculated from the KCCQ: the overall summary score (includes the total symptom, physical limitation, social limitations and quality of life scores) and the clinical summary score (combines the total symptom and physical limitation scales). Scores range from 0 to 100, with higher scores reflecting better health status. The KCCQ will be administered to participants as indicated. |
| Secondary | Change From Baseline to Week 30 in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) | 30 weeks | To compare the effect of a 30-week course of mavacamten on cardiac biomarkers |
| Secondary | Change From Baseline to Week 30 in Cardiac Troponin | 30 weeks | To compare the effect of a 30-week course of mavacamten on cardiac biomarkers |
| Secondary | Change From Baseline to Week 30 in Left Ventricular (LV) Mass Index | 30 weeks | To compare the effect of a 30-week course of mavacamten with placebo on LV mass evaluated by cardiac magnetic resonance (CMR) imaging. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 30 in Valsalva Left Ventricular Outflow Tract (LVOT) Peak Gradient | 30 weeks | mmHg | MEAN | |
| SECONDARY | Change From Baseline to Week 30 in Resting LVOT Peak Gradient | 30 weeks | mmHg | MEAN | |
| SECONDARY | Proportion of Participants Achieving a Valsalva LVOT Peak Gradient < 30 mmHg at Week 30 | 30 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Participants Achieving a Valsalva LVOT Peak Gradient < 50 mmHg at Week 30. | 30 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Participants With at Least 1 Class Improvement in New York Heart Association (NYHA) Functional Classification From Baseline to Week 30 | 30 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change From Baseline to Week 30 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) | 30 weeks | score on a scale | MEAN | |
| SECONDARY | Change From Baseline to Week 30 in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) | 30 weeks | ng/L | MEAN | |
| SECONDARY | Change From Baseline to Week 30 in Cardiac Troponin | 30 weeks | ng/L | MEAN | |
| SECONDARY | Change From Baseline to Week 30 in Left Ventricular (LV) Mass Index | 30 weeks | g/m^2 | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 30 in Valsalva Left Ventricular Outflow Tract (LVOT) Peak Gradient | Mavacamten | -51.05 | Standard Deviation 6.150 | mmHg | |
| Change From Baseline to Week 30 in Valsalva Left Ventricular Outflow Tract (LVOT) Peak Gradient | Placebo | 19.23 | Standard Deviation 8.535 | mmHg | |
| Change From Baseline to Week 30 in Resting LVOT Peak Gradient | Mavacamten | -49.04 | Standard Deviation 4.637 | mmHg | |
| Change From Baseline to Week 30 in Resting LVOT Peak Gradient | Placebo | 5.95 | Standard Deviation 6.311 | mmHg | |
| Proportion of Participants Achieving a Valsalva LVOT Peak Gradient < 30 mmHg at Week 30 | Mavacamten | 26 | Participants | ||
| Proportion of Participants Achieving a Valsalva LVOT Peak Gradient < 30 mmHg at Week 30 | Placebo | 1 | Participants | ||
| Proportion of Participants Achieving a Valsalva LVOT Peak Gradient < 50 mmHg at Week 30. | Mavacamten | 32 | Participants | ||
| Proportion of Participants Achieving a Valsalva LVOT Peak Gradient < 50 mmHg at Week 30. | Placebo | 2 | Participants | ||
| Proportion of Participants With at Least 1 Class Improvement in New York Heart Association (NYHA) Functional Classification From Baseline to Week 30 | Mavacamten | 32 | Participants | ||
| Proportion of Participants With at Least 1 Class Improvement in New York Heart Association (NYHA) Functional Classification From Baseline to Week 30 | Placebo | 4 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mavacamten | 54 | |
| Overall Study | STARTED | Placebo | 27 | |
| Overall Study | COMPLETED | Mavacamten | 54 | |
| Overall Study | COMPLETED | Placebo | 27 | |
| Overall Study | NOT COMPLETED | Mavacamten | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events48
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 | COVID-19 | Infections and infestations | Placebo | 11 | 27 | |
| other | COVID-19 | Infections and infestations | Mavacamten | 20 | 54 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 4 | 27 | |
| other | Upper respiratory tract infection | Infections and infestations | Mavacamten | 8 | 54 | |
| other | Defect conduction intraventricular | Cardiac disorders | Placebo | 0 | 27 | |
| other | Defect conduction intraventricular | Cardiac disorders | Mavacamten | 5 | 54 | |
| other | Palpitations | Cardiac disorders | Placebo | 2 | 27 | |
| other | Palpitations | Cardiac disorders | Mavacamten | 3 | 54 | |
| other | Ventricular extrasystoles | Cardiac disorders | Placebo | 3 | 27 | |
| other | Ventricular extrasystoles | Cardiac disorders | Mavacamten | 2 | 54 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 27 |
| Total, all-cause mortality | Mavacamten | 0 | 54 |
| Total, other adverse events | Placebo | 24 | 27 |
| Total, other adverse events | Mavacamten | 45 | 54 |
| Total, serious adverse events | Placebo | 0 | 27 |
| Total, serious adverse events | Mavacamten | 4 | 54 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mavacamten vs Placebo: Proportion of Participants Achieving a Valsalva LVOT Peak Gradient < 50 mmHg at Week 30. | Trial comparisons |
| Mavacamten vs Placebo: Proportion of Participants With at Least 1 Class Improvement in New York Heart Association (NYHA) Functional Classification From Baseline to Week 30 | Trial comparisons |
| Mavacamten vs Placebo: deaths from any cause | Trial comparisons |
| Mavacamten vs Placebo: Proportion of Participants Achieving a Valsalva LVOT Peak Gradient < 30 mmHg at Week 30 | Trial comparisons |
| Mavacamten vs Placebo: serious adverse events | Trial comparisons |
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/NCT05174416
GET https://conductscience.org/api/trials/v1/NCT05174416/events?page=2