Comparison · NCT01439009-79d92f74
Tolvaptan vs Placebo: Pulmonary Congestion
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: Pulmonary Congestion. Trial comparisons, record NCT01439009-79d92f74. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01439009-79d92f74
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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 | 0.6 | 0.446 | 0.737 | wilson | |
| Risk in group 2 | 0.476 | 0.334 | 0.623 | wilson | |
| Risk difference, group 1 minus group 2 | 0.124 | -0.0888 | 0.321 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.26 | 0.84 | 1.89 | log | |
| Odds ratio, group 1 over group 2 | 1.65 | 0.687 | 3.96 | log | |
| Number needed to treat, for one more participant with the outcome on Tolvaptan than on Placebo | 8.08 | 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 | 24 | 40 | OG000 |
| Group 2 | Placebo | Placebo~Placebo of tolvaptan: Once-daily oral administration of one placebo tablet in the morning | 20 | 42 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Pulmonary Congestion
- Description
Of the subjects who had pulmonary congestion at baseline, the number of subjects whose pulmonary congestion severity grading showed an improvement of one grade or more (eg, moderate to mild) at completion of treatment. Statistical comparison was not done.
- Time frame
- Day15
- 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.
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