Comparison · NCT01439009-4dcb64dc
Tolvaptan vs Placebo: Number of Subjects Whose New York Heart Association (NYHA) Classification Improved by One More Grade From Baseline
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Tolvaptan vs Placebo: Number of Subjects Whose New York Heart Association (NYHA) Classification Improved by One More Grade From Baseline. Trial comparisons, record NCT01439009-4dcb64dc. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01439009-4dcb64dc
On this page
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 | 0.468 | 0.333 | 0.608 | wilson | |
| Risk in group 2 | 0.545 | 0.401 | 0.683 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0774 | -0.27 | 0.124 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.858 | 0.571 | 1.29 | log | |
| Odds ratio, group 1 over group 2 | 0.733 | 0.321 | 1.67 | log | |
| Number needed to treat, for one fewer participant with the outcome on Tolvaptan than on Placebo | 12.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Tolvaptan | 15 mg~Tolvaptan: Once-daily oral administration of one tolvaptan 15 mg tablet in the morning | 22 | 47 | OG000 |
| Group 2 | Placebo | Placebo~Placebo of tolvaptan: Once-daily oral administration of one placebo tablet in the morning | 24 | 44 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Subjects Whose New York Heart Association (NYHA) Classification Improved by One More Grade From Baseline
- Description
New York Heart Association (NYHA) Classification is below ClassI：No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~ClassII：Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).~ClassIII：Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.~ClassIV：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
- The day after last IMP administration and Baseline
- Population
Source ClinicalTrials.gov
Trial
- Title
- Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients
- NCT number
- NCT01439009
- Phases
- PHASE4
- Conditions
- Heart Failure
- Interventions
- Tolvaptan, Placebo of tolvaptan
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Results first posted
- 2019-10-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01439009?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.govNo license 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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01439009-4dcb64dc