Trial · NCT01210560
Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD
NCT01210560, Phase 2, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2018-06-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD. Trials, record NCT01210560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01210560
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD
- NCT number
- NCT01210560
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Autosomal Dominant Polycystic Kidney Disease
- Interventions
- Tolvaptan MR, Tolvaptan MR, Tolvaptan MR, Tolvaptan IR, Tolvaptan MR
- First posted
- 2010-09-28
- Last updated
- 2018-06-14
- Results first posted
- 2018-06-14
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Blood samples (6 mL) for determination of tolvaptan PK parameters were collected on Day 1 predose, and on Days 7, 14 and 21 at predose, and 1, 2, 4, 6, 8, 9, 10, 12, 16, and 24 hours postdose. If a sample was not drawn at the designated time, a window of ± 3 minutes for each blood draw was acceptable. Maximum and minimum plasma concentration of the drug was calculated. |
| Primary | Time to Maximum (Peak) Plasma Concentration (Tmax) After Tolvaptan Treatment on Day 7. | Day 7 | Blood samples (6 mL) for determination of tolvaptan PK parameters were collected on Day 1 predose, and on Days 7, 14 and 21 at predose, and 1, 2, 4, 6, 8, 9, 10, 12, 16, and 24 hours postdose. If a sample was not drawn at the designated time, a window of ± 3 minutes for each blood draw was acceptable. Time to maximum plasma concentration was calculated. |
| 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 | Blood samples (6 mL) for determination of tolvaptan PK parameters were collected on Day 1 predose, and on Days 7, 14 and 21 at predose, and 1, 2, 4, 6, 8, 9, 10, 12, 16, and 24 hours postdose. If a sample was not drawn at the designated time, a window of ± 3 minutes for each blood draw was acceptable. Hence, both AUCT and AUC0-24h values were calculated. |
| Secondary | Number of Participants With Urine Osmolality < 300 mOsm/kg at 23.5 Hours Postdose. | 23.5 hours post-dose | For determination of duration of urine osmolality \<300 mOsm/kg, the value was the end time of the last collection interval in which urine osmolality was \<300 mOsm/kg. Day 8 in the table below was defined as Day 8 of Period 1, Day 15 of Period 2, and Day 22 of period 3. |
| 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 | The AUC0-24h for urine osmolality was determined by multiplying the concentration by the collection interval duration for each collection interval and summing all the intervals in the 24-hour period. If the urine volume for an interval is zero, the duration of that interval will be added to the next collection interval. Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2 and Day 21 of Period 3. |
| Secondary | Change From Baseline in Urine Osmolality at Day 7. | 0-4, 4-8, 8-12, 12-16, 16-24 Hours at Day 7 | To determine the tolerability and nighttime urinary suppression of osmolality. The urine osmolality was summarized by collection interval (0 to 4, 4 to 8, 8 to 12, 12 to 16, and 16 to 24 hours) |
| Secondary | Change From Baseline in Urine Volume at 24 Hours at Day 7. | Day 7 | Urine volume was collected by 0 to 24-hour interval at Day 7. Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2 and Day 21 of Period 3. |
| 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 | Urine volume collected was by interval (0-4, 4-8, 8-12, 12-16, 16-24 hours). Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2 and Day 21 of Period 3. |
| Secondary | Duration of Urine Osmolality Less Than 300 mOsm/kg at Baseline and Day 7. | Baseline and Day 7 | Duration of urine osmolality remains below 300 mOsm/kg was the sum of the durations (nominal times) of all intervals where the urine concentration was \< 300 mOsm/kg. Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2, and Day 21 of Period 3. |
| Secondary | Change From Baseline in Number of Urine Voids During Awake Periods. | Days 1, 2, 3, 4, 5, 6 and 7 | Average number of daily urine voids during awake periods for each dose group. Day 1 was defined as Day1 of Period 1, Day 8 of Period 2 adn Day 15 of Period 3; Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2 and Day 21 of Period 3; Same rule applied to Day 2 and Day 6. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group233
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum (Peak) Plasma Concentration of the Drug [Cmax] and Minimum (Trough) Plasma Concentration of the Drug [Cmin] After Tolvaptan Treatment on Day 7. | MR 20 mg | Cmax | 140 | Standard Deviation 68.4 | ng/mL |
| Maximum (Peak) Plasma Concentration of the Drug [Cmax] and Minimum (Trough) Plasma Concentration of the Drug [Cmin] After Tolvaptan Treatment on Day 7. | MR 20+20 mg | Cmax | 175 | Standard Deviation 60.1 | ng/mL |
| Maximum (Peak) Plasma Concentration of the Drug [Cmax] and Minimum (Trough) Plasma Concentration of the Drug [Cmin] After Tolvaptan Treatment on Day 7. | MR 60 mg | Cmax | 350 | Standard Deviation 156 | ng/mL |
| Maximum (Peak) Plasma Concentration of the Drug [Cmax] and Minimum (Trough) Plasma Concentration of the Drug [Cmin] After Tolvaptan Treatment on Day 7. | MR 120 mg | Cmax | 669 | Standard Deviation 370 | ng/mL |
| Maximum (Peak) Plasma Concentration of the Drug [Cmax] and Minimum (Trough) Plasma Concentration of the Drug [Cmin] After Tolvaptan Treatment on Day 7. | IR 90+30 mg | Cmax | 716 | Standard Deviation 344 | ng/mL |
| Maximum (Peak) Plasma Concentration of the Drug [Cmax] and Minimum (Trough) Plasma Concentration of the Drug [Cmin] After Tolvaptan Treatment on Day 7. | MR 20 mg | Cmin | 14.7 | Standard Deviation 9.95 | ng/mL |
| Maximum (Peak) Plasma Concentration of the Drug [Cmax] and Minimum (Trough) Plasma Concentration of the Drug [Cmin] After Tolvaptan Treatment on Day 7. | MR 20+20 mg | Cmin | 50.8 | Standard Deviation 24.0 | ng/mL |
| Maximum (Peak) Plasma Concentration of the Drug [Cmax] and Minimum (Trough) Plasma Concentration of the Drug [Cmin] After Tolvaptan Treatment on Day 7. | MR 60 mg | Cmin | 51.1 | Standard Deviation 32.3 | ng/mL |
| Maximum (Peak) Plasma Concentration of the Drug [Cmax] and Minimum (Trough) Plasma Concentration of the Drug [Cmin] After Tolvaptan Treatment on Day 7. | MR 120 mg | Cmin | 139 | Standard Deviation 75.5 | ng/mL |
| Maximum (Peak) Plasma Concentration of the Drug [Cmax] and Minimum (Trough) Plasma Concentration of the Drug [Cmin] After Tolvaptan Treatment on Day 7. | IR 90+30 mg | Cmin | 57.5 | Standard Deviation 41.8 | ng/mL |
1 to 10 of 233Source ClinicalTrials.gov
See all 233 results by groupParticipant flow81
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Intervention 1 (7 Days) | STARTED | Group 1: DAE | 2 | |
| Intervention 1 (7 Days) | STARTED | Group 1: DBE | 2 | |
| Intervention 1 (7 Days) | STARTED | Group 1: DCE | 2 | |
| Intervention 1 (7 Days) | STARTED | Group 1: EAD | 2 | |
| Intervention 1 (7 Days) | STARTED | Group 1: EBD | 2 | |
| Intervention 1 (7 Days) | STARTED | Group 1: ECD | 2 | |
| Intervention 1 (7 Days) | STARTED | Group 2: FGH | 4 | |
| Intervention 1 (7 Days) | STARTED | Group 2: HFG | 4 | |
| Intervention 1 (7 Days) | STARTED | Group 2: GHF | 5 | |
| Intervention 1 (7 Days) | COMPLETED | Group 1: DAE | 2 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 participant flowAdverse events150
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 | Abdominal distension | Gastrointestinal disorders | MR 20 mg | 0 | 17 | |
| other | Abdominal distension | Gastrointestinal disorders | MR 20+20 mg | 0 | 17 | |
| other | Abdominal distension | Gastrointestinal disorders | MR 60 mg | 0 | 17 | |
| other | Abdominal distension | Gastrointestinal disorders | MR 120 mg | 0 | 12 | |
| other | Abdominal distension | Gastrointestinal disorders | IR 90+30 mg | 1 | 12 | |
| other | Abdominal pain lower | Gastrointestinal disorders | MR 20 mg | 1 | 17 | |
| other | Abdominal pain lower | Gastrointestinal disorders | MR 20+20 mg | 0 | 17 | |
| other | Abdominal pain lower | Gastrointestinal disorders | MR 60 mg | 0 | 17 | |
| other | Abdominal pain lower | Gastrointestinal disorders | MR 120 mg | 0 | 12 | |
| other | Abdominal pain lower | Gastrointestinal disorders | IR 90+30 mg | 0 | 12 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MR 20 mg | ||
| Total, all-cause mortality | MR 20+20 mg | ||
| Total, all-cause mortality | MR 60 mg | ||
| Total, all-cause mortality | MR 120 mg | ||
| Total, all-cause mortality | IR 90+30 mg | ||
| Total, other adverse events | MR 20 mg | 5 | 17 |
| Total, other adverse events | MR 20+20 mg | 10 | 17 |
| Total, other adverse events | MR 60 mg | 6 | 17 |
| Total, other adverse events | MR 120 mg | 8 | 12 |
| Total, other adverse events | IR 90+30 mg | 7 | 12 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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