Trial · NCT02964273
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase A: Change From Baseline in Spot Urine Osmolality (Pre-morning Dose) | Baseline, and Week 1 of Phase A | The Full Analysis Set (FAS) included all participants who were randomized to a treatment group, received at least 1 dose of the investigational medicinal product (IMP), and had both a Phase A baseline and at least 1 postbaseline efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point. | milliosmoles per kilogram (mOsm/kg) | MEAN |
| PRIMARY | Phase A: Change From Baseline in Specific Gravity (Pre-morning Dose) | Baseline, and Week 1 of Phase A | The FAS included all participants who were randomized to a treatment group, received at least 1 dose of the IMP, and had both a Phase A baseline and at least 1 postbaseline efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point. | ratio | MEAN |
| SECONDARY | Phase A: Percent Change From Phase A Baseline in Height-Adjusted Total Kidney Volume (htTKV) as Measured by Magnetic Resonance Imaging (MRI) | Baseline, and Month 12 of Phase A | The FAS included all participants who were randomized to a treatment group, received at least 1 dose of the IMP, and had both a Phase A baseline and at least 1 postbaseline efficacy evaluation. Overall number analyzed are the number of participants with data available for analyses. | percent change | MEAN |
| SECONDARY | Phase A and B: Mean 24-hour Fluid Balance Prior to Week 1 | Prior to Week 1 in Phase A and B | The FAS for Phase A included all participants who were randomized to a treatment group, received at least 1 dose of the IMP, and had both a Phase A Baseline and at least 1 postbaseline efficacy evaluation. The FAS for Phase B included all participants who enrolled to Phase B, received at least 1 dose of the IMP, and had both a baseline and at least 1 postbaseline efficacy evaluation in Phase B. Overall number analyzed are the number of participants with data available for analyses. | milliliter | MEAN |
| SECONDARY | Phase A: Change From Baseline in Renal Function (Estimated Glomerular Filtration Rate [eGFR] by Schwartz Formula) at Each Clinic Visit in Phase A | Phase A Baseline, Months 1, 6, and 12 | The FAS included all participants who were randomized to a treatment group, received at least 1 dose of the IMP, and had both a Phase A baseline and at least 1 postbaseline efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point. | mL/min/1.73 m^2 | MEAN |
| SECONDARY | Phase B: Change From Phase B Baseline in Renal Function (eGFR by Schwartz Formula) at Each Clinic Visit in Phase B | Phase B Baseline, Week 1, Months 1, 6, 12, 18, and 24 | The FAS for Phase B included all participants who enrolled to Phase B, received at least 1 dose of the IMP, and had both a baseline and at least 1 postbaseline efficacy evaluation in Phase B. Number analyzed is the number of participants with data available for analysis at the given time point. | mL/min/1.73 m^2 | MEAN |
| SECONDARY | Phase B: Percent Change From Phase B Baseline in htTKV as Measured by MRI at Month 12 and Month 24 | Phase B Baseline, Months 12 and 24 | The FAS for Phase B included all participants who enrolled to Phase B, received at least 1 dose of the IMP, and had both a baseline and at least 1 postbaseline efficacy evaluation in Phase B. Number analyzed is the number of participants with data available for analysis at the given time point. | percent change | MEAN |
| SECONDARY | Phase A: 24-hour Urine Volume | 24 hours post dose after Month 1 on study medication in Phase A | The Dense Pharmacokinetic/Pharmacodynamic (PK/PD) Population included a subset of participants half on tolvaptan and half on placebo, in the 12 to 17 year old age group who had dense PK sampling after at least 1 month on IMP. Overall number analyzed are the number of participants with data available for analyses. | milliliter per 24 hours post dose | MEAN |
| SECONDARY | Phase A: 24-hour Fluid Intake | 24 hours post dose after Month 1 on study medication in Phase A | The Dense PK/PD Population included a subset of participants half on tolvaptan and half on placebo, in the 12 to 17 year old age group who had dense PK sampling after at least 1 month on IMP. Overall number analyzed are the number of participants with data available for analyses. | milliliter | MEAN |
| SECONDARY | Phase A: 24-hour Fluid Balance | 24 hours post dose after Month 1 on study medication in Phase A | The Dense PK/PD Population included a subset of participants half on tolvaptan and half on placebo, in the 12 to 17 year old age group who had dense PK sampling after at least 1 month on IMP. Overall number analyzed are the number of participants with data available for analyses. | milliliter | MEAN |
| SECONDARY | Phase A: 24-hour Sodium Clearance | 24 hours post dose after Month 1 on study medication in Phase A | The Dense PK/PD Population included a subset of participants half on tolvaptan and half on placebo, in the 12 to 17 year old age group who had dense PK sampling after at least 1 month on IMP. Overall number analyzed are the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis for the specified category. | milliliter per minute (mL/min) | MEAN |
| SECONDARY | Phase A: 24-hour Creatinine Clearance | 24 hours post dose after Month 1 on study medication in Phase A | The Dense PK/PD Population included a subset of participants half on tolvaptan and half on placebo, in the 12 to 17 year old age group who had dense PK sampling after at least 1 month on IMP. Overall number analyzed are the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis for the specified category. | mL/min | MEAN |
| SECONDARY | Phase A: 24-hour Free Water Clearance | 24 hours post dose after Month 1 on study medication in Phase A | The Dense PK/PD Population included a subset of participants half on tolvaptan and half on placebo, in the 12 to 17 year old age group who had dense PK sampling after at least 1 month on IMP. Overall number analyzed are the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis for the specified category. | mL/min | MEAN |
| SECONDARY | Phase A: Percentage of Each Tanner Stage by Gender and Age Compared to Normative Populations | At Baseline, Months 6 and 12 of Phase A | The Phase A Safety Set included all participants who were randomized and received at least 1 dose of IMP in Phase A. | percentage of participants | NUMBER |
| SECONDARY | Phase B: Percentage of Each Tanner Stage by Gender and Age Compared to Normative Populations | At Baseline, Months 6, 12, 18, and 24 of Phase B | The Phase B Safety Set included all participants who were enrolled in Phase B and received at least 1 dose of IMP in Phase B. | percentage of participants | NUMBER |
| SECONDARY | Phase A: Change From Baseline in Growth Percentile by Gender and Age | At Baseline, Months 6 and 12 of Phase A | The Phase A Safety Set included all participants who were randomized and received at least 1 dose of IMP in Phase A. Number analyzed is the number of participants with data available for analysis at the given time point. | growth percentile | MEAN |
| SECONDARY | Phase B: Change From Baseline in Growth Percentile by Gender and Age | At Baseline, Months 6, 12, 18, and 24 of Phase B | The Phase B Safety Set included all participants who were enrolled in Phase B and received at least 1 dose of IMP in Phase B. Number analyzed is the number of participants with data available for analysis at the given time point. | growth percentile | MEAN |
| SECONDARY | Phase A: Change From Baseline in Creatinine Value | Baseline, Week 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, Follow Up Day 7, End of Treatment, and Last Visit | The Phase A Safety Set included all participants who were randomized and received at least 1 dose of IMP in Phase A. Number analyzed is the number of participants with data available for analysis at the given time point. | milligrams per deciliter (mg/dL) | MEAN |
| SECONDARY | Phase B: Change From Baseline in Creatinine Value | Baseline, Week 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, Follow Up Day 7, End of Treatment, and Last Visit | The Phase B Safety Set included all participants who were enrolled in Phase B and received at least 1 dose of IMP in Phase B. Number analyzed is the number of participants with data available for analysis at the given time point. | mg/dL | MEAN |
| SECONDARY | Phase A and B: Percentage of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | From first dose of study drug up to 14 days post last dose (up to approximately 37 months) | The Phase A Safety Set included all participants who were randomized and received at least 1 dose of IMP in Phase A. The Phase B Safety Set included all participants who were enrolled in Phase B and received at least 1 dose of IMP in Phase B. Number analyzed is the number of participants with at least one post-baseline numeric result for the given vital sign parameter. | percentage of participants | NUMBER |
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.
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