Comparison · NCT04349072-4f31e4d8
Mavacamten vs Placebo to Mavacamten: Number of Participants With at Least One Class Improvement From Baseline in New York Heart Association (NYHA) Class at Week 16
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 vs Placebo to Mavacamten: Number of Participants With at Least One Class Improvement From Baseline in New York Heart Association (NYHA) Class at Week 16. Trial comparisons, record NCT04349072-4f31e4d8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04349072-4f31e4d8
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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 | 0.625 | 0.494 | 0.74 | wilson | |
| Risk in group 2 | 0.214 | 0.127 | 0.338 | wilson | |
| Risk difference, group 1 minus group 2 | 0.411 | 0.23 | 0.555 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.92 | 1.7 | 5.01 | log | |
| Odds ratio, group 1 over group 2 | 6.11 | 2.65 | 14.1 | log | |
| Number needed to treat, for one more participant with the outcome on Mavacamten than on Placebo to Mavacamten | 2.43 | 1.8 | 4.34 | 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 | Participants randomized to the mavacamten group started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 4 and up-titration at Weeks 8 and 12 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.~Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128). | 35 | 56 | OG000 |
| Group 2 | Placebo to Mavacamten | One placebo-to-match mavacamten capsule once daily for 16 weeks and then switch to mavacamten. After Week 16 through Week 32, participants started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 20 and up-titration at Weeks 24 and 28 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.~Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128). | 12 | 56 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With at Least One Class Improvement From Baseline in New York Heart Association (NYHA) Class at Week 16
- Description
The NYHA functional classification of heart failure assigns participants to 1 of 4 categories based on the participants symptoms. Baseline values are defined generally as the last available value before the first administration of study drug of analysis interest. Participants with missing NYHA class assessments are treated as no improvement.~Class 1: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~Class 2: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).~Class 3: Marked limitation of physical activity. Comfortable at rest. Less-than ordinary-activity causes fatigue, palpitation, or dyspnea. Class 4: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
- Time frame
- Baseline and week 16
- Population
- All randomized participants
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
- NCT number
- NCT04349072
- Phases
- PHASE3
- Conditions
- HOCM, Hypertrophic Obstructive Cardiomyopathy
- Interventions
- Mavacamten, Placebo
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2023-03-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04349072?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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