Trial · NCT02012959
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
NCT02012959, Phase 3, Terminated, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2018-08-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia. Trials, record NCT02012959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02012959
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
- NCT number
- NCT02012959
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 9 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Hyponatremia
- Interventions
- Tolvaptan
- First posted
- 2013-12-17
- Last updated
- 2018-09-26
- Other registries' IDs
- eudract:2013-002005-59
- Results first posted
- 2018-08-28
- Limitations and caveats
- Issues with recruitment and enrollment made trial execution highly impracticable. This ultimately led to termination of the trial. The study was not terminated due to safety reasons.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change In Serum Sodium Concentration For Responders | Day 2/2a, Day 4 | Change in serum sodium concentration (mEq/L) for responders from Day 2 (or Day 2a) at the end of Treatment Phase A (where all participants received tolvaptan) to the end of Treatment Phase B for the Early compared to Late Withdrawal groups is reported. Once a participant was randomized to Treatment Phase B, any additional therapies for the purpose of raising serum sodium, including fluid restriction, were considered rescue therapy. Upon receipt of rescue therapy, a participant's endpoint data was collected and then censored from the efficacy analysis thereafter, unless specified. |
| Secondary | Change In Serum Sodium Concentration During Treatment Phase A | Baseline, Day 2/2a | Change in serum sodium concentration (mEq/L) from baseline to the end of Day 2 (or 2a) during Treatment Phase A for all participants (responders and non-responders) is reported. |
| Secondary | Fluid Balance (Intake Minus Output) During Treatment Phase A | Every 6 hours on Days 1 and 2 | Every 6 hours and for the 24-hour daily interval on Days 1 and 2 during Treatment Phase A, fluid balance (milliliters \[mL\]) was determined by fluid intake (oral and intravenous) minus urine output. Improved fluid balance would be indicated through the induction of increased urine volume. Fluid balance was monitored per institutional guidelines. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change In Serum Sodium Concentration For Responders | Day 2/2a, Day 4 | Treatment Phase B Responders: full analysis dataset comprised of all participants in the Phase B Safety Sample with both baseline and at least 1 postrandomization serum sodium evaluation in Phase B. | mEq/L | MEAN |
| SECONDARY | Change In Serum Sodium Concentration During Treatment Phase A | Baseline, Day 2/2a | Treatment Phase A: all participants in the Phase A Safety Sample and who had baseline and at least 1 postbaseline serum sodium evaluation in Phase A. | mEq/L | MEAN |
| SECONDARY | Fluid Balance (Intake Minus Output) During Treatment Phase A | Every 6 hours on Days 1 and 2 | Treatment Phase A: all participants in the Phase A Safety Sample and who had baseline and at least 1 postbaseline serum sodium evaluation in Phase A. | mL | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change In Serum Sodium Concentration For Responders | Responder - Late Withdrawal | -4.0 | Standard Deviation 4.2 | mEq/L | |
| Change In Serum Sodium Concentration For Responders | Responder - Early Withdrawal | -1.0 | Standard Deviation 1.0 | mEq/L | |
| Change In Serum Sodium Concentration During Treatment Phase A | Phase A: All Participants | Day 1: 24 hours Post Dose | 1 | Standard Deviation 3 | mEq/L |
| Change In Serum Sodium Concentration During Treatment Phase A | Phase A: All Participants | Day 2: 24 hours Post Dose | 3.4 | Standard Deviation 4.8 | mEq/L |
| Change In Serum Sodium Concentration During Treatment Phase A | Phase A: All Participants | Day 2a: 24 hours Post Dose | 2.3 | Standard Deviation 2.1 | mEq/L |
| Fluid Balance (Intake Minus Output) During Treatment Phase A | Phase A: All Participants | Day 1: 0-6 hours | -1 | Standard Deviation 505 | mL |
| Fluid Balance (Intake Minus Output) During Treatment Phase A | Phase A: All Participants | Day 1: 6-12 hours | -261 | Standard Deviation 533 | mL |
| Fluid Balance (Intake Minus Output) During Treatment Phase A | Phase A: All Participants | Day 1: 12-18 hours | -36 | Standard Deviation 253 | mL |
| Fluid Balance (Intake Minus Output) During Treatment Phase A | Phase A: All Participants | Day 1: 18-24 hours | 31 | Standard Deviation 344 | mL |
| Fluid Balance (Intake Minus Output) During Treatment Phase A | Phase A: All Participants | Day 1: 0-24 hours | -268 | Standard Deviation 849 | mL |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Phase A | STARTED | Treatment Phase A | 9 | |
| Treatment Phase A | STARTED | Treatment Phase B: Responder - Late Withdrawal | 0 | |
| Treatment Phase A | STARTED | Treatment Phase B: Responder - Early Withdrawal | 0 | |
| Treatment Phase A | STARTED | Treatment Phase B: Non-responder - Study Drug | 0 | |
| Treatment Phase A | STARTED | Treatment Phase B: Non-responder - Standard of Care | 0 | |
| Treatment Phase A | Received At Least 1 Dose of Study Drug | Treatment Phase A | 9 | |
| Treatment Phase A | Received At Least 1 Dose of Study Drug | Treatment Phase B: Responder - Late Withdrawal | 0 | |
| Treatment Phase A | Received At Least 1 Dose of Study Drug | Treatment Phase B: Responder - Early Withdrawal | 0 | |
| Treatment Phase A | Received At Least 1 Dose of Study Drug | Treatment Phase B: Non-responder - Study Drug | 0 | |
| Treatment Phase A | Received At Least 1 Dose of Study Drug | Treatment Phase B: Non-responder - Standard of Care | 0 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood sodium decreased | Investigations | Treatment Phase A | 0 | 9 | |
| other | Blood sodium decreased | Investigations | Treatment Phase B: Responder - Late Withdrawal | 0 | 2 | |
| other | Blood sodium decreased | Investigations | Treatment Phase B: Responder - Early Withdrawal | 0 | 3 | |
| other | Blood sodium decreased | Investigations | Treatment Phase B: Non-responder - Study Drug | 0 | 1 | |
| other | Blood sodium decreased | Investigations | Treatment Phase B: Non-responder - Standard of Care | 1 | 1 | |
| other | Bradycardia | Cardiac disorders | Treatment Phase A | 0 | 9 | |
| other | Bradycardia | Cardiac disorders | Treatment Phase B: Responder - Late Withdrawal | 0 | 2 | |
| other | Bradycardia | Cardiac disorders | Treatment Phase B: Responder - Early Withdrawal | 1 | 3 | |
| other | Bradycardia | Cardiac disorders | Treatment Phase B: Non-responder - Study Drug | 0 | 1 | |
| other | Bradycardia | Cardiac disorders | Treatment Phase B: Non-responder - Standard of Care | 0 | 1 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Phase A | 0 | 9 |
| Total, all-cause mortality | Treatment Phase B: Responder - Late Withdrawal | 0 | 2 |
| Total, all-cause mortality | Treatment Phase B: Responder - Early Withdrawal | 0 | 3 |
| Total, all-cause mortality | Treatment Phase B: Non-responder - Study Drug | 0 | 1 |
| Total, all-cause mortality | Treatment Phase B: Non-responder - Standard of Care | 0 | 1 |
| Total, other adverse events | Treatment Phase A | 3 | 9 |
| Total, other adverse events | Treatment Phase B: Responder - Late Withdrawal | 1 | 2 |
| Total, other adverse events | Treatment Phase B: Responder - Early Withdrawal | 2 | 3 |
| Total, other adverse events | Treatment Phase B: Non-responder - Study Drug | 1 | 1 |
| Total, other adverse events | Treatment Phase B: Non-responder - Standard of Care | 1 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02012959
GET https://conductscience.org/api/trials/v1/NCT02012959/flow?page=2