Comparison · NCT03470545-4456aa68
Mavacamten (MYK-461) vs Placebo: Proportion of Participants With at Least 1 Class Improvement in NYHA Functional Class From Baseline to Week 30
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Mavacamten (MYK-461) vs Placebo: Proportion of Participants With at Least 1 Class Improvement in NYHA Functional Class From Baseline to Week 30. Trial comparisons, record NCT03470545-4456aa68. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03470545-4456aa68
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.65 | 0.563 | 0.729 | wilson | |
| Risk in group 2 | 0.313 | 0.239 | 0.397 | wilson | |
| Risk difference, group 1 minus group 2 | 0.338 | 0.216 | 0.446 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.08 | 1.56 | 2.78 | log | |
| Odds ratio, group 1 over group 2 | 4.09 | 2.42 | 6.93 | log | |
| Number needed to treat, for one more participant with the outcome on Mavacamten (MYK-461) than on Placebo | 2.96 | 2.24 | 4.63 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Mavacamten (MYK-461) | Mavacamten: mavacamten capsules~One mavacamten 2.5, 5, 10, or 15 mg capsule once daily by mouth for 30 weeks. The starting dose of mavacamten was 5 mg once daily by mouth. At Week 8 and Week 14, mavacamten dose may have been up-titrated for individual subjects based on prespecified criteria. Down-titration was possible at Week 6, Week 8, Week 14, Week 18, Week 22 and Week 26 for individual subjects based on prespecified criteria. | 80 | 123 | OG000 |
| Group 2 | Placebo | Placebo: placebo capsule~One placebo-to-match mavacamten capsule once daily by mouth for 30 weeks. A universal placebo capsule to match all strengths of mavacamten had the same appearance as mavacamten capsules but did not include the active ingredient. | 40 | 128 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Proportion of Participants With at Least 1 Class Improvement in NYHA Functional Class From Baseline to Week 30
- Description
New York Heart Association (NYHA) functional classification was determined by the principal investigator at baseline and at specified timepoints in the study. At baseline, all subjects were NYHA Class II or III. For the secondary outcome, NYHA class at Week 30 was compared to baseline and the proportion of subjects with an improvement of at least one class was determined, and the difference between treatment groups was analyzed. The proportion was also multiplied by 100 to provide the result as a percent.
- Time frame
- 30 weeks
- Population
Source ClinicalTrials.gov
Trial
- Title
- Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
- NCT number
- NCT03470545
- Phases
- PHASE3
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Interventions
- mavacamten, Placebo
- Lead sponsor
- MyoKardia, Inc.
- Results first posted
- 2021-10-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03470545?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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