A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®)… (NCT01451411) | Clinical Trial Compass
TerminatedPhase 3
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia
Stopped: Enrollment goals were not met.
United States, Colombia4 participantsStarted 2012-02
Plain-language summary
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of intravenous conivaptan in pediatric subjects with abnormally low concentration of sodium in blood.
Who can participate
Age range2 Years – 17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is euvolemic or hypervolemic hyponatremia upon clinical presentation
* Subject has serum sodium value ≥ 115 mEq/L (115 mmol/L) and \< 130 mEq/L (130 mmol/L) during the 24 hours preceding inclusion into the study
* Female subject of childbearing potential must have a negative serum pregnancy test and must be premenarchal, surgically sterile or must practice a method of birth control
Exclusion Criteria:
* Female subject is pregnant or lactating
* Subject has a body mass index (BMI) \< the 3rd percentile or \> the 97th percentile for their age and stature according to the World Health Organization; Body mass index-for-age percentiles charts for boys and girls ages 2 to 20
* Subject has clinical evidence of volume depletion, dehydration or hypovolemia
* Subject with hypovolemic hyponatremia or transient causes of hyponatremia that are likely to resolve during the time of study participation
* Subjects with a cause of hyponatremia that is most appropriately corrected by alternative therapies
* Subject is expected to receive emergent treatment for hyponatremia during the treatment period of the study
* Subject has clinical evidence of hypotension
* Subject has uncontrolled hypertension \> the 99th percentile for their age
* Subject has uncontrolled bradyarrhythmias or tachyarrhythmias requiring emergent pacemaker placement or treatment
* Subject has untreated severe hypothyroidism, hyperthyroidism or adrenal insufficiency
* Subject has known urinary…
What they're measuring
1
Mean Change From Baseline to the End of the 48-hour Treatment Period in Serum Sodium