Comparison · NCT03470545-ea5eb0c6
Mavacamten (MYK-461) vs Placebo: Percentage of Participants Achieving A Clinical Response
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: Percentage of Participants Achieving A Clinical Response. Trial comparisons, record NCT03470545-ea5eb0c6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03470545-ea5eb0c6
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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 | 0.366 | 0.286 | 0.454 | wilson | |
| Risk in group 2 | 0.172 | 0.116 | 0.247 | wilson | |
| Risk difference, group 1 minus group 2 | 0.194 | 0.0847 | 0.298 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.13 | 1.36 | 3.32 | log | |
| Odds ratio, group 1 over group 2 | 2.78 | 1.54 | 5 | log | |
| Number needed to treat, for one more participant with the outcome on Mavacamten (MYK-461) than on Placebo | 5.16 | 3.36 | 11.8 | 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 6, Week 8, and Week 14, mavacamten dose may have been up-titrated or down-titrated for individual subjects based on prespecified criteria. | 45 | 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. | 22 | 128 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Percentage of Participants Achieving A Clinical Response
- Description
A positive clinical response (value=YES) is defined as having achieved either an improvement of at least 1.5 mL/kg/min in peak oxygen consumption (pVO2) as determined by cardiopulmonary exercise testing (CPET) and a reduction of one or more class in New York Heart Association (NYHA) functional classification (e.g.I, II, III, or IV) -OR- an improvement of 3.0 mL/kg/min or more in pVO2 with no worsening in NYHA Functional Class.
- 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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