A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia

• Status: Terminated
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cumberland Pharmaceuticals
• Treatments: Conivaptan

Criteria

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 outflow obstruction, unless subject is, or can be catheterized during the study

• Subject has estimated creatinine clearance < 30 mL/min during the seven days prior to study drug administration

• Subject has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations > 3 times the upper limit of normal reference range during the seven days prior to study drug administration

• Subject has serum albumin ≤ 1.5 g/dL during the seven days prior to study drug administration

• Subject has white blood cell count (WBC) < 3000/micro-liter documented any time during seven days prior to study drug administration or anticipated drop in WBC to < 3000/micro-liter during the period of the study due to chemotherapy

• Subject currently has unstable hepatic function or a history of hepatic encephalopathy, or bleeding esophageal varices within the last 3 months

• Subject has acute heart failure. Prior history of heart failure is allowed if there are no current signs/symptoms

• Subject has a non-fasting blood glucose value ≥ 275 mg/dL

• Subject requires or is suspected to require treatment with potent inhibitors or potent inducers of CYP3A4

• Subject was administered hypertonic saline or oral salt supplement within 24 hours prior to study drug administration

• Subject requires the use of medications used in the treatment of Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH): including lithium salts, urea or demeclocycline during the week prior to screening and throughout the study drug treatment period

• Subject has any condition that may interfere with treatment or evaluation of safety

• Subject has received investigational therapy (including placebo) within 28 days or 5 half lives, whichever is longer