Comparison · NCT00550459-d2815ccb
Tolvaptan (15-60 mg) vs Placebo: Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcF Increase 30-60 Msec
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 (15-60 mg) vs Placebo: Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcF Increase 30-60 Msec. Trial comparisons, record NCT00550459-d2815ccb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00550459-d2815ccb
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 | 0.103 | 0.0358 | 0.264 | wilson | |
| Risk in group 2 | 0.0714 | 0.0198 | 0.226 | wilson | |
| Risk difference, group 1 minus group 2 | 0.032 | -0.137 | 0.201 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.45 | 0.261 | 8.02 | log | |
| Odds ratio, group 1 over group 2 | 1.5 | 0.231 | 9.73 | log | |
| Number needed to treat, for one more participant with the outcome on Tolvaptan (15-60 mg) than on Placebo | 31.2 | 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 (15-60 mg) | Tolvaptan tablet 15-60 mg given once daily for 21 days | 3 | 29 | OG001 |
| Group 2 | Placebo | Placebo tablet given once daily for 21 days | 2 | 28 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcF Increase 30-60 Msec
- Description
- Incidence of potentially clinically significant ECG abnormalities (QTcF increase 30-60 msec post-baseline)
- Time frame
- 28 days
- Population
- Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication
Source ClinicalTrials.gov
Trial
- Title
- Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients
- NCT number
- NCT00550459
- Phases
- PHASE3
- Conditions
- Hyponatremia
- Interventions
- Tolvaptan, Placebo
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Results first posted
- 2011-04-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00550459?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/NCT00550459-d2815ccb