Trial · NCT01451411
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia
NCT01451411, Phase 3, Terminated, Cumberland Pharmaceuticals; results first posted 2016-03-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia. Trials, record NCT01451411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01451411
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia
- NCT number
- NCT01451411
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 4 participants, actual
- Lead sponsor
- Cumberland Pharmaceuticals
- Conditions
- Hyponatremia
- Interventions
- Conivaptan hydrochloride, Placebo
- First posted
- 2011-10-13
- Last updated
- 2016-03-01
- Results first posted
- 2016-03-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline to the End of the 48-hour Treatment Period in Serum Sodium | baseline and 48 hours | |
| Secondary | Time From the First Dose of Study Medication to a Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium | 48 hours | |
| Secondary | Number of Patients With Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium | baseline and 48 hours | |
| Secondary | Number of Subjects With Confirmed > 6 mEq/L Increase From Baseline in Serum Sodium or a Confirmed Normal Serum Sodium Level (Greater Than or Equal to 135 mEq/L) | baseline and 48 hours | |
| Secondary | Change From Baseline in Effective Water Clearance (EWC) Every 12 Hours | Baseline, Hours 12, 24, 36 and 48 | |
| Secondary | Change From Baseline in Free Water Clearance (FWC) | Baseline and 48 hours | |
| Secondary | Number of Participants With an Overly Rapid Rise in Serum Sodium From Baseline | baseline and Hours 3, 8, 12 and 24. | an absolute serum sodium of 145 mEq/L at Hour 24 or an increase in serum sodium of greater than 12 mEq/L |
| Secondary | Population Pharmacokinetics: Clearance (CL) | Up to Hour 60 | Based on conivaptan concentrations, the pharmacokinetics of the study population will be analyzed to determine median CL |
| Secondary | Population Pharmacokinetics: Volume of Distribution (Vd) | Up to Hour 60 | Based on conivaptan concentrations, the pharmacokinetics of the study population will be analyzed to determine median Vd |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline to the End of the 48-hour Treatment Period in Serum Sodium | baseline and 48 hours | mEq/L | MEAN | |
| SECONDARY | Time From the First Dose of Study Medication to a Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium | 48 hours | Data from two subjects (one conivaptan, and one placebo) were censored as the serum sodium never achieved a value greater or equal to 4 mEq/L above the baseline value. | hours | MEAN |
| SECONDARY | Number of Patients With Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium | baseline and 48 hours | participants | NUMBER | |
| SECONDARY | Number of Subjects With Confirmed > 6 mEq/L Increase From Baseline in Serum Sodium or a Confirmed Normal Serum Sodium Level (Greater Than or Equal to 135 mEq/L) | baseline and 48 hours | participants | NUMBER | |
| SECONDARY | Change From Baseline in Effective Water Clearance (EWC) Every 12 Hours | Baseline, Hours 12, 24, 36 and 48 | The protocol specifies that calculations for this endpoint were to be derived by the statistical team. Due to the terminated status of the study, a statistical team was not employed and calculations to determine this variable were not performed. | ||
| SECONDARY | Change From Baseline in Free Water Clearance (FWC) | Baseline and 48 hours | The protocol specifies that calculations for this endpoint were to be derived by the statistical team. Due to the terminated status of the study, a statistical team was not employed and calculations to determine this variable were not performed. | ||
| SECONDARY | Number of Participants With an Overly Rapid Rise in Serum Sodium From Baseline | baseline and Hours 3, 8, 12 and 24. | participants | NUMBER | |
| SECONDARY | Population Pharmacokinetics: Clearance (CL) | Up to Hour 60 | Due to the terminated status of the study, pharmacokinetic samples were not analyzed. | ||
| SECONDARY | Population Pharmacokinetics: Volume of Distribution (Vd) | Up to Hour 60 | Due to the terminated status of the study, pharmacokinetic samples were not analyzed. |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline to the End of the 48-hour Treatment Period in Serum Sodium | Conivaptan Hydrochloride | 6.0 | Standard Deviation 5.3 | mEq/L | |
| Mean Change From Baseline to the End of the 48-hour Treatment Period in Serum Sodium | Placebo | -4.0 | mEq/L | ||
| Time From the First Dose of Study Medication to a Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium | Conivaptan Hydrochloride | 21.5 | Full Range 2.5 to 40.5 | hours | |
| Number of Patients With Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium | Conivaptan Hydrochloride | 2 | participants | ||
| Number of Patients With Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium | Placebo | 0 | participants | ||
| Number of Subjects With Confirmed > 6 mEq/L Increase From Baseline in Serum Sodium or a Confirmed Normal Serum Sodium Level (Greater Than or Equal to 135 mEq/L) | Conivaptan Hydrochloride | 1 | participants | ||
| Number of Subjects With Confirmed > 6 mEq/L Increase From Baseline in Serum Sodium or a Confirmed Normal Serum Sodium Level (Greater Than or Equal to 135 mEq/L) | Placebo | 0 | participants | ||
| Number of Participants With an Overly Rapid Rise in Serum Sodium From Baseline | Conivaptan Hydrochloride | 0 | participants | ||
| Number of Participants With an Overly Rapid Rise in Serum Sodium From Baseline | Placebo | 0 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Conivaptan Hydrochloride | 3 | |
| Overall Study | STARTED | Placebo | 1 | |
| Overall Study | COMPLETED | Conivaptan Hydrochloride | 3 | |
| Overall Study | COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Conivaptan Hydrochloride | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events14
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 | Pyrexia | General disorders | Conivaptan Hydrochloride | 1 | 3 | 1 |
| other | Pyrexia | General disorders | Placebo | 0 | 1 | 0 |
| other | Hypertension | Vascular disorders | Conivaptan Hydrochloride | 2 | 3 | 2 |
| other | Hypertension | Vascular disorders | Placebo | 0 | 1 | 0 |
| other | Skin disorder | Skin and subcutaneous tissue disorders | Conivaptan Hydrochloride | 0 | 3 | 0 |
| other | Skin disorder | Skin and subcutaneous tissue disorders | Placebo | 1 | 1 | 1 |
| other | Extrasystoles | Cardiac disorders | Conivaptan Hydrochloride | 0 | 3 | 0 |
| other | Extrasystoles | Cardiac disorders | Placebo | 1 | 1 | 1 |
| other | Vomiting | Gastrointestinal disorders | Conivaptan Hydrochloride | 0 | 3 | 0 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 1 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Conivaptan Hydrochloride | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Conivaptan Hydrochloride | 2 | 3 |
| Total, other adverse events | Placebo | 1 | 1 |
| Total, serious adverse events | Conivaptan Hydrochloride | 1 | 3 |
| Total, serious adverse events | Placebo | 0 | 1 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Conivaptan Hydrochloride vs Placebo: Number of Subjects With Confirmed > 6 mEq/L Increase From Baseline in Serum Sodium or a Confirmed Normal Serum Sodium Level (Greater Than or Equal to 135 mEq/L) | Trial comparisons |
| Conivaptan Hydrochloride vs Placebo: Number of Participants With an Overly Rapid Rise in Serum Sodium From Baseline | Trial comparisons |
| Conivaptan Hydrochloride vs Placebo: Number of Patients With Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium | Trial comparisons |
| Conivaptan Hydrochloride vs Placebo: serious adverse events | 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/NCT01451411
GET https://conductscience.org/api/trials/v1/NCT01451411/registered