Trial · NCT01227512
Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia
NCT01227512, Phase 3, Terminated, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2014-10-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia. Trials, record NCT01227512. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01227512
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia
- NCT number
- NCT01227512
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 124 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Hyponatremia, Dilutional Hyponatremia, Inappropriate ADH Syndrome
- Interventions
- tolvaptan, Fluid Restriction
- First posted
- 2010-10-25
- Last updated
- 2014-10-30
- Results first posted
- 2014-10-17
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Length of Hospital Stay (LoS) | 45 days | LoS was time to clinically ready to be hospital discharged (CRBD) from study treatment initiation, disregarding prolonged hospitalization due solely to social factors. |
| Secondary | Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms. | Baseline to 48 hours post dose | Change from baseline in blinded rater assessed CGI-S at 48 hours post-first dose or at discharge/rescue therapy, if earlier was assessed. The CGI-S is a one-question rating scale which was as follows: "Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time?" 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients. |
| Secondary | Change From Baseline to 24 and 72 Hours Post Dose in CGI-S of Hyponatremia Symptoms. | Baseline to 24 and 72 hours post dose | Change in CGI-S of hyponatremia symptoms from pretreatment baseline at 24 and 72 hours post-first dose, or at discharge/rescue therapy if earlier was assessed. The CGI-S is a one-question rating scale which was as follows: "Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time?" 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients. |
| Secondary | Change From Baseline to 48 Hours Post Dose in Clinical Global Impression - Improvement (CGI-I) Score of Hyponatremia Symptoms. | Baseline to 48 hours post dose | Change in CGI-I score at 48 hours post-first dose or discharge/rescue therapy, if earlier was assessed. The CGI-I is a one-question rating scale where the participant is asked to rate total improvement whether or not, in their judgment, it is due entirely to trial treatment. Compared to his/her condition at admission to the trial, how much has he/she changed? 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse |
| Secondary | Change From Baseline in Serum Sodium Concentration (24 Hour Area Under the Curve [AUC]). | 0 to 72 hours | Average 24 hour AUC of serum sodium concentration change from baseline, from Day 1 Hour 0 up to 72 hours post-first dose was assessed. A serum sodium sample was drawn at pre-treament and 8, 24, 48, and 72 hours post-first dose. Serum sodium was also assessed between 36 and 72 hours after the last dose. Analysis of AUC was for daily average AUC, hence the units or AUC are mEq/L/24 hours. |
| Secondary | Time to First 2-point Improvement in CGI-S Score. | Up to 72 hours | CGI-S data up to 72 hours were used to identify 2-point improvements. Please refer to outcome measure 2 for details on the scale. For the analysis of time to first 2-point improvement in CGI-S, CGI-S data up to Hour 72 were used to identify 2-point improvements. Data for participants who received rescue therapy were censored at the time of receiving rescue therapy. For participants who were discharged before Hour 72 without reaching 2-point improvement in CGI-S, data were censored at the time of discharge. Other participants who did not reach the 2-point improvement during the 72 hours also had their data censored at their last CGI-S observations within 72 hours. |
| Secondary | Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Score Improved to a Score of 1 or 2. | 48 hours post dose | Percentage of responders (defined as CGI-I score of 1 = very much improved or 2 = much improved) at 48 hours post-first dose, or at discharge/rescue therapy, if earlier. Participants given rescue therapy were given a score of 7. |
| Secondary | Percentage of Participants Requiring Rescue Therapy for Hyponatremia | 7 days | Percentage of participants requiring rescue therapy within first 7 days of treatment for hyponatremia. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Length of Hospital Stay (LoS) | 45 days | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. | Days | MEDIAN |
| SECONDARY | Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms. | Baseline to 48 hours post dose | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.~Data were missing for one participant in the Tolvaptan group. | Units on a scale | MEDIAN |
| SECONDARY | Change From Baseline to 24 and 72 Hours Post Dose in CGI-S of Hyponatremia Symptoms. | Baseline to 24 and 72 hours post dose | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.~Data were missing for one participant in the Tolvaptan group. | Units on a scale | MEDIAN |
| SECONDARY | Change From Baseline to 48 Hours Post Dose in Clinical Global Impression - Improvement (CGI-I) Score of Hyponatremia Symptoms. | Baseline to 48 hours post dose | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were not available for 2 participants in the tolvaptan group. | Units on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Serum Sodium Concentration (24 Hour Area Under the Curve [AUC]). | 0 to 72 hours | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.~Data were missing for 3 participants in the tolvaptan group and 1 participant in the placebo group. | mEq/L | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First 2-point Improvement in CGI-S Score. | Up to 72 hours | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 1 participant in the tolvaptan group and 3 participants in the placebo group. | Hours | MEDIAN |
| SECONDARY | Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Score Improved to a Score of 1 or 2. | 48 hours post dose | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 2 participants in the tolvaptan group and 3 participants in the placebo group. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Requiring Rescue Therapy for Hyponatremia | 7 days | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 3 participants in the placebo group. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Length of Hospital Stay (LoS) | Tolvaptan 15-60mg/Day | 3.5 | 95% Confidence Interval 3.0 to 4.5 | Days | |
| Length of Hospital Stay (LoS) | Placebo | 4.0 | 95% Confidence Interval 3.5 to 5.0 | Days | |
| Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms. | Tolvaptan 15-60mg/Day | Baseline | 4.0 | Full Range 2.0 to 6.0 | Units on a scale |
| Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms. | Placebo | Baseline | 4.0 | Full Range 3.0 to 6.0 | Units on a scale |
| Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms. | Tolvaptan 15-60mg/Day | 48 hours post dose | 2.0 | Full Range 1.0 to 6.0 | Units on a scale |
| Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms. | Placebo | 48 hours post dose | 3.0 | Full Range 1.0 to 7.0 | Units on a scale |
| Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms. | Tolvaptan 15-60mg/Day | Change from baseline | -1.0 | Full Range -3.0 to 3.0 | Units on a scale |
| Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms. | Placebo | Change from baseline | -1.0 | Full Range -3.0 to 3.0 | Units on a scale |
| Change From Baseline to 24 and 72 Hours Post Dose in CGI-S of Hyponatremia Symptoms. | Tolvaptan 15-60mg/Day | Baseline | 4.0 | Full Range 2.0 to 6.0 | Units on a scale |
| Change From Baseline to 24 and 72 Hours Post Dose in CGI-S of Hyponatremia Symptoms. | Placebo | Baseline | 4.0 | Full Range 3.0 to 6.0 | Units on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tolvaptan 15-60 mg/Day | 66 | |
| Overall Study | STARTED | Placebo | 58 | |
| Overall Study | COMPLETED | Tolvaptan 15-60 mg/Day | 53 | |
| Overall Study | COMPLETED | Placebo | 48 | |
| Overall Study | NOT COMPLETED | Tolvaptan 15-60 mg/Day | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 10 |
Source ClinicalTrials.gov
Adverse events88
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 | Tolvaptan 15-60 mg/Day | 4 | 66 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 0 | 55 | |
| other | Abdominal pain | Gastrointestinal disorders | Tolvaptan 15-60 mg/Day | 3 | 66 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 3 | 55 | |
| other | Constipation | Gastrointestinal disorders | Tolvaptan 15-60 mg/Day | 10 | 66 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 6 | 55 | |
| other | Diarrhoea | Gastrointestinal disorders | Tolvaptan 15-60 mg/Day | 3 | 66 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 55 | |
| other | Nausea | Gastrointestinal disorders | Tolvaptan 15-60 mg/Day | 5 | 66 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 55 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tolvaptan 15-60 mg/Day | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Tolvaptan 15-60 mg/Day | 52 | 66 |
| Total, other adverse events | Placebo | 43 | 55 |
| Total, serious adverse events | Tolvaptan 15-60 mg/Day | 18 | 66 |
| Total, serious adverse events | Placebo | 9 | 55 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tolvaptan 15-60 mg/Day vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT01227512
GET https://conductscience.org/api/trials/v1/NCT01227512/results?page=2