Trial · NCT01210560
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum (Peak) Plasma Concentration of the Drug [Cmax] and Minimum (Trough) Plasma Concentration of the Drug [Cmin] After Tolvaptan Treatment on Day 7. | Day 7 | Participants having valid measurements (per clinical pharmacology) were included. | ng/mL | MEAN |
| PRIMARY | Time to Maximum (Peak) Plasma Concentration (Tmax) After Tolvaptan Treatment on Day 7. | Day 7 | Participants having valid measurements (per clinical pharmacology) were included. | Hours | MEDIAN |
| PRIMARY | Area Under the Concentration-time Curve During the Dosing Interval at Steady State and Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUCT & AUC0-24h) After Tolvaptan Treatment on Day 7. | Day 7 | Participants having valid measurements (per clinical pharmacology) were included. | ng·h/mL | MEAN |
| SECONDARY | Number of Participants With Urine Osmolality < 300 mOsm/kg at 23.5 Hours Postdose. | 23.5 hours post-dose | All participants who had taken study drug and had measurements of the pharmacodynamic endpoint were included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Urine Osmolality Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24h) at Day 7. | Day 7 | All participants who had taken study drug and had measurements of the pharmacodynamic endpoint were included. | mOsm/kg*Hour | MEAN |
| SECONDARY | Change From Baseline in Urine Osmolality at Day 7. | 0-4, 4-8, 8-12, 12-16, 16-24 Hours at Day 7 | All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included. | mOsm/kg | MEAN |
| SECONDARY | Change From Baseline in Urine Volume at 24 Hours at Day 7. | Day 7 | All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included. | mL | MEAN |
| SECONDARY | Change From Baseline in Urine Volume by Interval at Day 7. | 0-4, 4-8, 8-12, 12-16, 16-24 Hours at Day 7 | All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included. | mL | MEAN |
| SECONDARY | Duration of Urine Osmolality Less Than 300 mOsm/kg at Baseline and Day 7. | Baseline and Day 7 | The duration that urine osmolality remained \< 300 mOsm/kg was not calculated. Instead was calculated as the sum where urine osmolality was \< 300 mOsm/kg in the 24-hour postdose period. The change was made because low doses of the MR formulation frequently do not produce suppression of urine osmolality in the 0- to 4-hour period. | Hours | MEDIAN |
| SECONDARY | Change From Baseline in Number of Urine Voids During Awake Periods. | Days 1, 2, 3, 4, 5, 6 and 7 | All participants who had taken study drug and had measurements of the pharmacodynamic endpoint were included. | Number of urine voids | MEAN |
| SECONDARY | Change From Baseline in Number of Urine Voids During Sleep Periods. | Days 1, 2, 3, 4, 5, 6 and 7 | All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included. | Number of urine voids | MEAN |
| SECONDARY | Change From Baseline in Symptom Burden by Autosomal Dominant Polycystic Kidney Disease (ADPKD) Nocturia Quality of Life Questionnaire at Day 6. | Day 6 | All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included. | Units on a scale | MEAN |
| SECONDARY | Number of Participants Experiencing Urinary Urgency Based on Urinary Urgency Questionnaire (Question 1) at Baseline and Day 6. | Baseline and Day 6 | All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Urinary Urgency Questionnaire (Questions 2 to 5 and Questions 7 to 14) at Day 6. | Day 6 | All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included. | Units on a scale | MEAN |
| SECONDARY | Number of Participants Experiencing Urinary Frequency Based on Urinary Frequency Questionnaire (Question 1) at Baseline and Day 6. | Baseline and Day 6 | All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Urinary Frequency Questionnaire (Question 2 and Questions 3 to 10) at Day 6. | Day 6 | All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included. | Units on a scale | MEAN |
| SECONDARY | Ranking of Treatment Tolerability. | Day 22/Early Termination | All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included. | 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01210560/outcomes