Trial · NCT02020278
An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia
NCT02020278, Phase 3, Terminated, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2020-04-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia. Trials, record NCT02020278. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02020278
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia
- NCT number
- NCT02020278
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 3 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Hyponatremia
- Interventions
- Tolvaptan
- First posted
- 2013-12-24
- Last updated
- 2020-04-17
- Results first posted
- 2020-04-17
- Limitations and caveats
- This trial was prematurely terminated due to challenges in enrollment. The trial was not terminated due to safety reasons. Due to early termination of the study, no efficacy data were collected.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline At Month 6 In Serum Sodium While Tolvaptan Was Being Administered | Baseline, Month 6 | No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure. |
| Secondary | Percentage Of Participants Who Required Rescue Therapy While On Tolvaptan Treatment | Month 6 | No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure. |
| Secondary | Percentage Of Participants Who Had Recurrence Of Hyponatremia While On Tolvaptan | Month 6 | No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure. |
| Secondary | Percentage Of Participants Requiring Continuation Of Tolvaptan Following 30 Days Of Treatment | Month 6 | No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure. |
| Secondary | Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Total Score At Month 6 | Baseline, Month 6 | The PedsQL GCS was used for quality of life assessment. It is appropriate for at least 2 years of age, however availability may be limited for certain ages and languages. It encompasses 4 dimensions of functioning (physical, emotional, social, school). The age groups covered are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Adolescent (13-18 years). Depending on the participant's age, the questionnaire may be completed by either the participant or the parent/caregiver, as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the Young Child, and a 5-point Likert scale for the Child and Adolescent groups. Scores are transformed on a scale from 0 to 100 and averaged. Higher scores indicate improved quality of life. The change from baseline in the GCS total score is presented. |
| Secondary | Change From Baseline In PedsQL GCS Physical Health Summary Score At Month 6 | Baseline, Month 6 | The PedsQL GCS was used for quality of life assessment. It is appropriate for at least 2 years of age, however availability may be limited for certain ages and languages. It encompasses 4 dimensions of functioning (physical, emotional, social, school). The age groups covered are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Adolescent (13-18 years). Depending on the participant's age, the questionnaire may be completed by either the participant or the parent/caregiver, as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the Young Child, and a 5-point Likert scale for the Child and Adolescent groups. Scores are transformed on a scale from 0 to 100 and averaged. Higher scores indicate improved quality of life. The change from baseline in the physical health dimension is presented. |
| Secondary | Change From Baseline In PedsQL GCS Psychosocial Health Summary Score At Month 6 | Baseline, Month 6 | The PedsQL GCS was used for quality of life assessment. It is appropriate for at least 2 years of age, however availability may be limited for certain ages and languages. It encompasses 4 dimensions of functioning (physical, emotional, social, school). The age groups covered are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Adolescent (13-18 years). Depending on the participant's age, the questionnaire may be completed by either the participant or the parent/caregiver, as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the Young Child, and a 5-point Likert scale for the Child and Adolescent groups. Scores are transformed on a scale from 0 to 100 and averaged. Higher scores indicate improved quality of life. The change from baseline in summed emotional, social, and school dimensions is presented. |
| Secondary | Change From Baseline In PedsQL Multidimensional Fatigue Scale (MFS) Total Score At Month 6 | Baseline, Month 6 | The PedsQL GCS was used for quality of life assessment. It is appropriate for at least 2 years of age, however availability may be limited for certain ages and languages. It encompasses 4 dimensions of functioning (physical, emotional, social, school). The age groups covered are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Adolescent (13-18 years). Depending on the participant's age, the questionnaire may be completed by either the participant or the parent/caregiver, as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the Young Child, and a 5-point Likert scale for the Child and Adolescent groups. Scores are transformed on a scale from 0 to 100 and averaged. Higher scores indicate improved quality of life. The change from baseline in summed emotional, social, and school dimensions is presented. |
| Secondary | Percentage Of Participants With Overly Rapid Correction In Serum Sodium 24 Hours After The First Dose At Introduction Or Reintroduction Of Tolvaptan | Month 6 | No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure. |
| Secondary | Plasma Concentrations Of Tolvaptan And Metabolites In Participants Who Had Continued Tolvaptan Therapy For Eight Consecutive Weeks | 8 Weeks | No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline At Month 6 In Serum Sodium While Tolvaptan Was Being Administered | Baseline, Month 6 | No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected. | ||
| SECONDARY | Percentage Of Participants Who Required Rescue Therapy While On Tolvaptan Treatment | Month 6 | No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected. | ||
| SECONDARY | Percentage Of Participants Who Had Recurrence Of Hyponatremia While On Tolvaptan | Month 6 | No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected. | ||
| SECONDARY | Percentage Of Participants Requiring Continuation Of Tolvaptan Following 30 Days Of Treatment | Month 6 | No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected. | ||
| SECONDARY | Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Total Score At Month 6 | Baseline, Month 6 | All enrolled participants with analyzable data at specified timepoint. No enrolled participant received any investigational medicinal product during the study. | units on a scale | MEAN |
| SECONDARY | Change From Baseline In PedsQL GCS Physical Health Summary Score At Month 6 | Baseline, Month 6 | All enrolled participants with analyzable data at specified timepoint. No enrolled participant received any investigational medicinal product during the study. | units on a scale | MEAN |
| SECONDARY | Change From Baseline In PedsQL GCS Psychosocial Health Summary Score At Month 6 | Baseline, Month 6 | All enrolled participants with analyzable data at specified timepoint. No enrolled participant received any investigational medicinal product during the study. | units on a scale | MEAN |
| SECONDARY | Change From Baseline In PedsQL Multidimensional Fatigue Scale (MFS) Total Score At Month 6 | Baseline, Month 6 | All enrolled participants with analyzable data at specified timepoint. No enrolled participant received any investigational medicinal product during the study. | units on a scale | MEAN |
| SECONDARY | Percentage Of Participants With Overly Rapid Correction In Serum Sodium 24 Hours After The First Dose At Introduction Or Reintroduction Of Tolvaptan | Month 6 | No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected. | ||
| SECONDARY | Plasma Concentrations Of Tolvaptan And Metabolites In Participants Who Had Continued Tolvaptan Therapy For Eight Consecutive Weeks | 8 Weeks | No enrolled participant received any investigational medicinal product during the study. Due to early study termination, no pharmacokinetic analyses were performed. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Total Score At Month 6 | Core Safety Follow-up Component | -3.5 | Full Range -3.5 to -3.5 | units on a scale | |
| Change From Baseline In PedsQL GCS Physical Health Summary Score At Month 6 | Core Safety Follow-up Component | 12.5 | Full Range 12.5 to 12.5 | units on a scale | |
| Change From Baseline In PedsQL GCS Psychosocial Health Summary Score At Month 6 | Core Safety Follow-up Component | -13.5 | Full Range -13.5 to -13.5 | units on a scale | |
| Change From Baseline In PedsQL Multidimensional Fatigue Scale (MFS) Total Score At Month 6 | Core Safety Follow-up Component | 9.7 | Full Range 9.7 to 9.7 | units on a scale | |
| Participants With A Tanner Staging Score Of 1 At Month 6 | Core Safety Follow-up Component | 2 | Participants | ||
| Change From Baseline In Growth Percentiles For Body Height And Weight At Month 6 | Core Safety Follow-up Component | Height Percentile | 19.0 | Standard Deviation 40.0 | percentile |
| Change From Baseline In Growth Percentiles For Body Height And Weight At Month 6 | Core Safety Follow-up Component | Weight Percentile | 0.7 | Standard Deviation 8.0 | percentile |
| Change From Baseline In Alanine Aminotransferase (ALT) And Aspartate Aminotransferase (AST) For Participants On Tolvaptan At Month 2 | Core Safety Follow-up Component | ALT | -10.00 | Standard Deviation 45.25 | U/L |
| Change From Baseline In Alanine Aminotransferase (ALT) And Aspartate Aminotransferase (AST) For Participants On Tolvaptan At Month 2 | Core Safety Follow-up Component | AST | -7.50 | Standard Deviation 0.71 | U/L |
| Change From Baseline In Bilirubin For Participants On Tolvaptan At Month 2 | Core Safety Follow-up Component | 2.57 | Standard Deviation 3.63 | umol/L |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Safety Follow-up Component | STARTED | Tolvaptan | 3 | |
| Core Safety Follow-up Component | COMPLETED | Tolvaptan | 3 | |
| Core Safety Follow-up Component | NOT COMPLETED | Tolvaptan | 0 | |
| Optional Tolvaptan Treatment Component | STARTED | Tolvaptan | 0 | |
| Optional Tolvaptan Treatment Component | COMPLETED | Tolvaptan | 0 | |
| Optional Tolvaptan Treatment Component | NOT COMPLETED | Tolvaptan | 0 |
Source ClinicalTrials.gov
Adverse events10
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 | Pyrexia | General disorders | Tolvaptan | 1 | 3 | |
| other | Bronchitis | Infections and infestations | Tolvaptan | 1 | 3 | |
| other | Enterovirus Infection | Infections and infestations | Tolvaptan | 1 | 3 | |
| other | Rhinovirus Infection | Infections and infestations | Tolvaptan | 1 | 3 | |
| other | Urosepsis | Infections and infestations | Tolvaptan | 1 | 3 | |
| other | Viral Upper Respiratory Tract Infection | Infections and infestations | Tolvaptan | 1 | 3 | |
| serious | Pyrexia | General disorders | Tolvaptan | 1 | 3 | |
| serious | Enterovirus Infection | Infections and infestations | Tolvaptan | 1 | 3 | |
| serious | Rhinovirus Infection | Infections and infestations | Tolvaptan | 1 | 3 | |
| serious | Urosepsis | Infections and infestations | Tolvaptan | 1 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tolvaptan | 0 | 3 |
| Total, other adverse events | Tolvaptan | 2 | 3 |
| Total, serious adverse events | Tolvaptan | 1 | 3 |
Source ClinicalTrials.gov
Papers0
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/NCT02020278
GET https://conductscience.org/api/trials/v1/NCT02020278/registered