Trial · NCT02251275
Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
NCT02251275, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2019-11-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease. Trials, record NCT02251275. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02251275
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
- NCT number
- NCT02251275
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,803 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Interventions
- Tolvaptan
- First posted
- 2014-09-29
- Last updated
- 2019-11-27
- Results first posted
- 2019-11-27
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Baseline through end of treatment (up to 42 months) and follow-up 7 days posttreatment(+ 7 days) | An adverse event (AE) was as any untoward medical occurrence associated with the use of an investigational medicinal product (IMP), whether or not considered IMP related. A TEAE was an AE that started after trial drug treatment; or if the event was continuous from baseline and was serious, related to IMP, or resulted in death, discontinuation, interruption or reduction of trial therapy. A serious TEAE included any event that resulted in: death, life-threatening, persistent or significant incapacity, substantial disruption of ability to conduct normal life functions, required inpatient hospitalization, prolonged hospitalization, congenital anomaly/birth defect, or other medically significant events as per medical judgment, that jeopardized the participant and that required medical or surgical intervention. A severe TEAE was an inability to work or perform normal daily activity. A summary of serious and all other non-serious TEAEs, regardless of causality, is located in the AE section. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Baseline through end of treatment (up to 42 months) and follow-up 7 days posttreatment(+ 7 days) | All participants who received at least 1 dose of study drug. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Tolvaptan (From 156-13-210: Tolvaptan) | Participants with TEAEs | 473 | participants | |
| Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Tolvaptan (From 156-13-210: Placebo) | Participants with TEAEs | 531 | participants | |
| Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Tolvaptan (From 156-08-271: Tolvaptan) | Participants with TEAEs | 640 | participants | |
| Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Tolvaptan (From Other: Tolvaptan) | Participants with TEAEs | 6 | participants | |
| Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Tolvaptan (From Other: Placebo) | Participants with TEAEs | 3 | participants | |
| Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Tolvaptan (From 156-13-210: Tolvaptan) | Participants with serious TEAEs | 87 | participants | |
| Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Tolvaptan (From 156-13-210: Placebo) | Participants with serious TEAEs | 96 | participants | |
| Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Tolvaptan (From 156-08-271: Tolvaptan) | Participants with serious TEAEs | 103 | participants | |
| Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Tolvaptan (From Other: Tolvaptan) | Participants with serious TEAEs | 1 | participants | |
| Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Tolvaptan (From Other: Placebo) | Participants with serious TEAEs | 2 | participants |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tolvaptan (From 156-13-210: Tolvaptan) | 506 | |
| Overall Study | STARTED | Tolvaptan (From 156-13-210: Placebo) | 570 | |
| Overall Study | STARTED | Tolvaptan (From 156-08-271: Tolvaptan) | 718 | |
| Overall Study | STARTED | Tolvaptan (From Other: Tolvaptan) | 6 | |
| Overall Study | STARTED | Tolvaptan (From Other: Placebo) | 3 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Tolvaptan (From 156-13-210: Tolvaptan) | 505 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Tolvaptan (From 156-13-210: Placebo) | 569 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Tolvaptan (From 156-08-271: Tolvaptan) | 717 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Tolvaptan (From Other: Tolvaptan) | 6 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Tolvaptan (From Other: Placebo) | 3 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,605
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 | Left Ventricular Hypertrophy | Cardiac disorders | Tolvaptan (From 156-13-210: Tolvaptan) | 0 | 505 | 0 |
| other | Left Ventricular Hypertrophy | Cardiac disorders | Tolvaptan (From 156-13-210: Placebo) | 0 | 569 | 0 |
| other | Left Ventricular Hypertrophy | Cardiac disorders | Tolvaptan (From 156-08-271: Tolvaptan) | 0 | 717 | 0 |
| other | Left Ventricular Hypertrophy | Cardiac disorders | Tolvaptan (From Other: Tolvaptan) | 1 | 6 | 1 |
| other | Left Ventricular Hypertrophy | Cardiac disorders | Tolvaptan (From Other: Placebo) | 0 | 3 | 0 |
| other | Palpitations | Cardiac disorders | Tolvaptan (From 156-13-210: Tolvaptan) | 5 | 505 | 5 |
| other | Palpitations | Cardiac disorders | Tolvaptan (From 156-13-210: Placebo) | 6 | 569 | 6 |
| other | Palpitations | Cardiac disorders | Tolvaptan (From 156-08-271: Tolvaptan) | 14 | 717 | 15 |
| other | Palpitations | Cardiac disorders | Tolvaptan (From Other: Tolvaptan) | 1 | 6 | 1 |
| other | Palpitations | Cardiac disorders | Tolvaptan (From Other: Placebo) | 0 | 3 | 0 |
1 to 10 of 1,605Source ClinicalTrials.gov
See all 1,605 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tolvaptan (From 156-13-210: Tolvaptan) | 1 | 505 |
| Total, all-cause mortality | Tolvaptan (From 156-13-210: Placebo) | 5 | 569 |
| Total, all-cause mortality | Tolvaptan (From 156-08-271: Tolvaptan) | 3 | 717 |
| Total, all-cause mortality | Tolvaptan (From Other: Tolvaptan) | 0 | 6 |
| Total, all-cause mortality | Tolvaptan (From Other: Placebo) | 0 | 3 |
| Total, other adverse events | Tolvaptan (From 156-13-210: Tolvaptan) | 469 | 505 |
| Total, other adverse events | Tolvaptan (From 156-13-210: Placebo) | 525 | 569 |
| Total, other adverse events | Tolvaptan (From 156-08-271: Tolvaptan) | 633 | 717 |
| Total, other adverse events | Tolvaptan (From Other: Tolvaptan) | 6 | 6 |
| Total, other adverse events | Tolvaptan (From Other: Placebo) | 3 | 3 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02251275
GET https://conductscience.org/api/trials/v1/NCT02251275/results?page=2