Trial · NCT02449044
International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia
NCT02449044, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2016-01-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia. Trials, record NCT02449044. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02449044
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia
- NCT number
- NCT02449044
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 111 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Hyponatremia
- Interventions
- Tolvaptan
- First posted
- 2015-05-20
- Last updated
- 2016-01-21
- Results first posted
- 2016-01-21
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With Adverse Events (AEs) | Baseline to Post-Week 214 follow-up visit | A TEAE was an AE that began after the first injection or was continuous from Baseline and was defined as any new medical problem, or exacerbation of an existing problem, whether or not it was considered drug-related by the study physician. An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-subject hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent the outcomes mentioned above. |
| Primary | Participants With Laboratory Values Abnormalities Reported as TEAEs | Baseline to Post-Week 214 follow-up visit | The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. Any value outside the normal range was flagged for the attention of the study physician who was to indicate whether the value was clinically significant for identifying laboratory values of potential clinical relevance. Participants noted with abnormal laboratory values are reported below. |
| Primary | Participants With Electrocardiogram (ECG) Related Abnormalities Reported as TEAEs | Baseline to Post-Week 214 follow-up visit | The ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in HR outliers, PR outliers, QRS outliers, QT, QTcB, QTcF that were identified based on pre-defined criteria. Some of the pre-defined criteria for identifying ECG measurements of potential clinical relevance included: For QTcB and QTcF: baseline mean of QTcB and QTcF interval was new onset \>500 msec, 30 - 60 msec, \>60 msec; For QT: new onset \>500 msec; For QRS outliers: \>=25% change from baseline when QRS \>100 msec; PR outliers: \>=25% change from baseline when PR\>200 msec; HR outliers: 25% decrease from baseline and HR \<50 bpm or 25% increase from baseline and HR \>100 bpm. New onset (\>500 msec) in QT, QTcB, or QTcF means a participant who attained a value \>500 msec during treatment period but not at each baseline visit. The ECG-related abnormalities are reported as TEAEs are mentioned below. |
| Primary | Participants With Vital Signs Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs) | Baseline to Post-Week 214 follow-up visit | The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria. Criteria for identifying vital signs of potential clinical relevance included: Heart rate, supine: \>= 120 beats per minute (bpm) + increase of ≥15 bpm from Baseline and \<=50 bpm + decrease of \>= 15 bpm; Diastolic Blood Pressure, Supine: \>=105 mmHg + increase of \>=15 mmHg and \<=50 mmHg + decrease of \>=15 mmHg; Systolic Blood Pressure, Supine: \>=180 mmHg + increase of \>=20 mmHg and \<= 90 mmHg + decrease of \>=20 mmHg; Temperature (degree C): Increase of \>=1.1 to \>=38.3C. The vital sign abnormalities were reported as TEAEs are mentioned below. |
| Primary | Participants With Body Weight Abnormalities Reported as TEAEs | Baseline to Post-Week 214 follow-up visit | The body weight evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Every effort was made to ensure that body weight measurements were performed in a reproducible and consistent manner. The pre-defined criteria was change of ≥7% in body weight for both male and female. Participants were to wear the same type of clothes at each measurement, preferably a gown and no shoes. All body weight measurements were to have been taken post-void. |
| Secondary | Mean Change From Baseline in Serum Sodium Measurements | Baseline of parent trial to Week 214 | Sodium measurements obtained at designated intervals were compared to each participant's Baseline sodium level at the beginning of placebo-controlled therapy in their original trial and from Baseline on initiation of therapy in the open-label trial. |
| Secondary | Change From Baseline in Percentage of Participants With Severe Hyponatremia | Baseline to Week 214 | Percentage of participants with varying degrees of hyponatremia ("severe" \<130, "mild" 130-135, "normal" \>135 mEq/L) at Baseline and each study visit. |
| Secondary | Change From Baseline in Percentage of Participants With Mild Hyponatremia | Baseline to Week 214 | Percentage of participants with varying degrees of hyponatremia ("severe" \<130, "mild" 130-135, "normal" \>135 mEq/L) at Baseline and each study visit. |
| Secondary | Change From Baseline in Percentage of Participants With Normal Sodium Levels | Baseline to Week 214 | Percentage of participants with varying degrees of hyponatremia ("severe" \<130, "mild" 130-135, "normal" \>135 mEq/L) at Baseline and each study visit. |
| Secondary | Percentage of Participants Requiring Prescription of Fluid Restriction | Baseline to Post-Week 214 follow-up visit | Percentage of participants requiring prescription of fluid restriction for the express purpose of treating hyponatremia during each period of the trial. Assessed descriptively at each visit. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With Adverse Events (AEs) | Baseline to Post-Week 214 follow-up visit | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. | participants | NUMBER |
| PRIMARY | Participants With Laboratory Values Abnormalities Reported as TEAEs | Baseline to Post-Week 214 follow-up visit | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. | participants | NUMBER |
| PRIMARY | Participants With Electrocardiogram (ECG) Related Abnormalities Reported as TEAEs | Baseline to Post-Week 214 follow-up visit | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. | participants | NUMBER |
| PRIMARY | Participants With Vital Signs Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs) | Baseline to Post-Week 214 follow-up visit | The intent-to-treat (ITT) dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. | participants | NUMBER |
| PRIMARY | Participants With Body Weight Abnormalities Reported as TEAEs | Baseline to Post-Week 214 follow-up visit | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. | participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Serum Sodium Measurements | Baseline of parent trial to Week 214 | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward. | mEq/L | MEAN |
| SECONDARY | Change From Baseline in Percentage of Participants With Severe Hyponatremia | Baseline to Week 214 | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Percentage of Participants With Mild Hyponatremia | Baseline to Week 214 | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Percentage of Participants With Normal Sodium Levels | Baseline to Week 214 | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Requiring Prescription of Fluid Restriction | Baseline to Post-Week 214 follow-up visit | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward. | percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group207
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With Adverse Events (AEs) | Tolvaptan | Participants with TEAEs | 105 | participants | |
| Participants With Adverse Events (AEs) | Tolvaptan | Participants with serious TEAEs | 76 | participants | |
| Participants With Adverse Events (AEs) | Tolvaptan | Participants with severe TEAEs | 73 | participants | |
| Participants With Adverse Events (AEs) | Tolvaptan | Participants discontinued IMP due to TEAE | 19 | participants | |
| Participants With Adverse Events (AEs) | Tolvaptan | Participants discontinued IMP due to TEAE/death | 28 | participants | |
| Participants With Adverse Events (AEs) | Tolvaptan | Deaths | 19 | participants | |
| Participants With Laboratory Values Abnormalities Reported as TEAEs | Tolvaptan | Serum Chemistry-Blood creatinine increased | 4 | participants | |
| Participants With Laboratory Values Abnormalities Reported as TEAEs | Tolvaptan | Serum Chemistry-Blood potassium increased | 4 | participants | |
| Participants With Laboratory Values Abnormalities Reported as TEAEs | Tolvaptan | Serum Chemistry-Blood glucose increased | 3 | participants | |
| Participants With Laboratory Values Abnormalities Reported as TEAEs | Tolvaptan | Serum Chemistry-Blood potassium decreased | 3 | participants |
1 to 10 of 207Source ClinicalTrials.gov
See all 207 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 | 111 | |
| Overall Study | COMPLETED | Tolvaptan | 47 | |
| Overall Study | NOT COMPLETED | Tolvaptan | 64 |
Source ClinicalTrials.gov
Adverse events205
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 | 16 | 111 | |
| other | Hypothyroidism | Endocrine disorders | Tolvaptan | 6 | 111 | |
| other | Abdominal pain | Gastrointestinal disorders | Tolvaptan | 7 | 111 | |
| other | Ascites | Gastrointestinal disorders | Tolvaptan | 11 | 111 | |
| other | Constipation | Gastrointestinal disorders | Tolvaptan | 8 | 111 | |
| other | Diarrhoea | Gastrointestinal disorders | Tolvaptan | 20 | 111 | |
| other | Dyspepsia | Gastrointestinal disorders | Tolvaptan | 6 | 111 | |
| other | Nausea | Gastrointestinal disorders | Tolvaptan | 18 | 111 | |
| other | Vomiting | Gastrointestinal disorders | Tolvaptan | 10 | 111 | |
| other | Asthenia | General disorders | Tolvaptan | 6 | 111 |
1 to 10 of 205Source ClinicalTrials.gov
See all 205 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tolvaptan | ||
| Total, other adverse events | Tolvaptan | 86 | 111 |
| Total, serious adverse events | Tolvaptan | 76 | 111 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20185637 | RESULT |
Source PubMed
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/NCT02449044
GET https://conductscience.org/api/trials/v1/NCT02449044/results?page=2