Trial · NCT02020278
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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. | ||
| SECONDARY | Participants With A Tanner Staging Score Of 1 At Month 6 | Month 6 | All enrolled participants with analyzable data at specified timepoint. No enrolled participant received any investigational medicinal product during the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline In Growth Percentiles For Body Height And Weight 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. | percentile | MEAN |
| SECONDARY | Change From Baseline In Alanine Aminotransferase (ALT) And Aspartate Aminotransferase (AST) For Participants On Tolvaptan At Month 2 | Baseline, Month 2 | All enrolled participants with analyzable data at specified timepoint. No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected. | U/L | MEAN |
| SECONDARY | Change From Baseline In Bilirubin For Participants On Tolvaptan At Month 2 | Baseline, Month 2 | All enrolled participants with analyzable data at specified timepoint. No enrolled participant received any investigational medicinal product during the study. | umol/L | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02020278/outcomes