Trial · NCT03048747
A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH
NCT03048747, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2020-11-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH. Trials, record NCT03048747. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03048747
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH
- NCT number
- NCT03048747
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 16 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Syndrome of Inappropriate Antidiuretic Hormone Secretion
- Interventions
- Tolvaptan Oral Tablet
- First posted
- 2017-02-09
- Last updated
- 2020-11-02
- Results first posted
- 2020-11-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration | Baseline, Day2, Day3, Day4, Day5, Day7, Day14, Day21, Day after final study medication | The percentage of subjects with normalized serum sodium concentration, defined as ≥135 mEq/L, on the day after final IMP administration will be calculated versus the number of subjects with serum sodium concentration of \<135 mEq/L at baseline on Day 1 of the treatment period. |
| Secondary | Change in Serum Sodium Concentration | Day2, Day3, Day4, Day5, Day7, Day14, Day21 and the day after final IMP administration | The mean and standard error of measured values for serum sodium concentration on the day of fixing the maintenance dose and on the day after final IMP administration were calculated. The day of fixing the maintenance dose: Day2, Day3, Day4, Day5, Day7, Day14, and Day21 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration | Baseline, Day2, Day3, Day4, Day5, Day7, Day14, Day21, Day after final study medication | Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation. | percentage of participants | NUMBER |
| SECONDARY | Change in Serum Sodium Concentration | Day2, Day3, Day4, Day5, Day7, Day14, Day21 and the day after final IMP administration | Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation. | mEq/L | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration | Tolvaptan | Day2 | 43.8 | percentage of participants | |
| Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration | Tolvaptan | Day3 | 80 | percentage of participants | |
| Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration | Tolvaptan | Day4 | 80 | percentage of participants | |
| Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration | Tolvaptan | Day5 | 85.7 | percentage of participants | |
| Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration | Tolvaptan | Day7 | 92.9 | percentage of participants | |
| Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration | Tolvaptan | Day14 | 83.3 | percentage of participants | |
| Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration | Tolvaptan | Day21 | 81.8 | percentage of participants | |
| Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration | Tolvaptan | Day after final study medication | 81.3 | percentage of participants | |
| Change in Serum Sodium Concentration | Tolvaptan | Day2 | 6.9 | Standard Error 2.6 | mEq/L |
| Change in Serum Sodium Concentration | Tolvaptan | Day3 | 8.1 | Standard Error 3.8 | mEq/L |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tolvaptan | 16 | |
| Overall Study | COMPLETED | Tolvaptan | 11 | |
| Overall Study | NOT COMPLETED | Tolvaptan | 5 |
Source ClinicalTrials.gov
Adverse events65
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 | Anaemia | Blood and lymphatic system disorders | Tolvaptan | 1 | 16 | |
| other | Neutropenia | Blood and lymphatic system disorders | Tolvaptan | 2 | 16 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tolvaptan | 1 | 16 | |
| other | Cardiac failure congestive | Cardiac disorders | Tolvaptan | 1 | 16 | |
| other | Supraventricular extrasystoles | Cardiac disorders | Tolvaptan | 1 | 16 | |
| other | Ventricular extrasystoles | Cardiac disorders | Tolvaptan | 1 | 16 | |
| other | Cerumen impaction | Ear and labyrinth disorders | Tolvaptan | 1 | 16 | |
| other | Cataract | Eye disorders | Tolvaptan | 1 | 16 | |
| other | Anorectal disorder | Gastrointestinal disorders | Tolvaptan | 1 | 16 | |
| other | Constipation | Gastrointestinal disorders | Tolvaptan | 2 | 16 |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tolvaptan | 1 | 16 |
| Total, other adverse events | Tolvaptan | 15 | 16 |
| Total, serious adverse events | Tolvaptan | 5 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03048747
GET https://conductscience.org/api/trials/v1/NCT03048747/events?page=2