Trial Outcomes & Findings for A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia (NCT NCT01451411)
NCT ID: NCT01451411
Last Updated: 2016-03-01
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
4 participants
Primary outcome timeframe
baseline and 48 hours
Results posted on
2016-03-01
Participant Flow
Participant milestones
| Measure |
Conivaptan Hydrochloride
Conivaptan hydrochloride: Intravenous
|
Placebo
Placebo: Intravenous
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia
Baseline characteristics by cohort
| Measure |
Conivaptan Hydrochloride
n=3 Participants
Conivaptan hydrochloride: Intravenous
|
Placebo
n=1 Participants
Placebo: Intravenous
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
2 - 5 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Age, Customized
6 - 10 years
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Age, Customized
11 - 17 years
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Colombia
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 48 hoursOutcome measures
| Measure |
Conivaptan Hydrochloride
n=3 Participants
Conivaptan hydrochloride: Intravenous
|
Placebo
n=1 Participants
Placebo: Intravenous
|
|---|---|---|
|
Mean Change From Baseline to the End of the 48-hour Treatment Period in Serum Sodium
|
6.0 mEq/L
Standard Deviation 5.3
|
-4.0 mEq/L
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: 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.
Outcome measures
| Measure |
Conivaptan Hydrochloride
n=2 Participants
Conivaptan hydrochloride: Intravenous
|
Placebo
Placebo: Intravenous
|
|---|---|---|
|
Time From the First Dose of Study Medication to a Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium
|
21.5 hours
Interval 2.5 to 40.5
|
—
|
SECONDARY outcome
Timeframe: baseline and 48 hoursOutcome measures
| Measure |
Conivaptan Hydrochloride
n=3 Participants
Conivaptan hydrochloride: Intravenous
|
Placebo
n=1 Participants
Placebo: Intravenous
|
|---|---|---|
|
Number of Patients With Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: baseline and 48 hoursOutcome measures
| Measure |
Conivaptan Hydrochloride
n=3 Participants
Conivaptan hydrochloride: Intravenous
|
Placebo
n=1 Participants
Placebo: Intravenous
|
|---|---|---|
|
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)
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Hours 12, 24, 36 and 48Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 48 hoursPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Conivaptan Hydrochloride
n=3 Participants
Conivaptan hydrochloride: Intravenous
|
Placebo
n=1 Participants
Placebo: Intravenous
|
|---|---|---|
|
Number of Participants With an Overly Rapid Rise in Serum Sodium From Baseline
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to Hour 60Population: Due to the terminated status of the study, pharmacokinetic samples were not analyzed.
Based on conivaptan concentrations, the pharmacokinetics of the study population will be analyzed to determine median CL
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Hour 60Population: Due to the terminated status of the study, pharmacokinetic samples were not analyzed.
Based on conivaptan concentrations, the pharmacokinetics of the study population will be analyzed to determine median Vd
Outcome measures
Outcome data not reported
Adverse Events
Conivaptan Hydrochloride
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conivaptan Hydrochloride
n=3 participants at risk
Conivaptan hydrochloride: Intravenous
|
Placebo
n=1 participants at risk
Placebo: Intravenous
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Stevens_Johnson Syndrome
|
33.3%
1/3 • Number of events 1 • Through Day 32
Serious adverse events were collected through Day 32; non-serious adverse events were collected through Day 9.
|
0.00%
0/1 • Through Day 32
Serious adverse events were collected through Day 32; non-serious adverse events were collected through Day 9.
|
Other adverse events
| Measure |
Conivaptan Hydrochloride
n=3 participants at risk
Conivaptan hydrochloride: Intravenous
|
Placebo
n=1 participants at risk
Placebo: Intravenous
|
|---|---|---|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • Through Day 32
Serious adverse events were collected through Day 32; non-serious adverse events were collected through Day 9.
|
0.00%
0/1 • Through Day 32
Serious adverse events were collected through Day 32; non-serious adverse events were collected through Day 9.
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Number of events 2 • Through Day 32
Serious adverse events were collected through Day 32; non-serious adverse events were collected through Day 9.
|
0.00%
0/1 • Through Day 32
Serious adverse events were collected through Day 32; non-serious adverse events were collected through Day 9.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3 • Through Day 32
Serious adverse events were collected through Day 32; non-serious adverse events were collected through Day 9.
|
100.0%
1/1 • Number of events 1 • Through Day 32
Serious adverse events were collected through Day 32; non-serious adverse events were collected through Day 9.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3 • Through Day 32
Serious adverse events were collected through Day 32; non-serious adverse events were collected through Day 9.
|
100.0%
1/1 • Number of events 1 • Through Day 32
Serious adverse events were collected through Day 32; non-serious adverse events were collected through Day 9.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Through Day 32
Serious adverse events were collected through Day 32; non-serious adverse events were collected through Day 9.
|
100.0%
1/1 • Number of events 1 • Through Day 32
Serious adverse events were collected through Day 32; non-serious adverse events were collected through Day 9.
|
|
Cardiac disorders
Accelerated idioventricular rhythm
|
0.00%
0/3 • Through Day 32
Serious adverse events were collected through Day 32; non-serious adverse events were collected through Day 9.
|
100.0%
1/1 • Number of events 1 • Through Day 32
Serious adverse events were collected through Day 32; non-serious adverse events were collected through Day 9.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI can publish data generated at their study site after multi-center study data have already been published, or after 18 months have elapsed following database lock, whichever comes first. The sponsor may review manuscripts before submission and delay publication by an additional 60 days, if necessary.
- Publication restrictions are in place
Restriction type: OTHER