Euvolemic or Hypervolemic Hyponatremia MedDRA version: 18.0 Level: LLT Classification code 10021038 Term: Hyponatremia System Organ Class: 100000004861
Conditions
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects = 4 weeks (or = 44 weeks adjusted gestational age) to =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Has evidence of hypovolemia or intravascular volume depletion (eg, hypotension, clinical evidence of volume depletion, response to saline challenge); if the subject has systolic blood pressure or heart rate outside of the normal range for that age volume status should be specifically clinically assessed to rule out volume depletion. 2. Has serum sodium level 300 mg/dL (16.7 mmol/L). 17. Has screening liver function values (ALT/AST) > 3 × ULN. 18. Has deficient coagulation (eg, cirrhotic at risk of GI bleed), including subjects who meet any of the following criteria: a major GI bleed within the past 6 months, evidence of active bleeding (eg, epistaxis, petechiae/purpura, hematuria, or hematochezia), platelet count < 50,000/µL, or use of concomitant medications known to increase bleeding risk. 19. Has hyponatremia due to the result of any medication that can safely be withdrawn (eg, thiazide diuretics). 20. Has hyponatremia (eg, hyponatremia in the setting of adrenal insufficiency, untreated hypothyroidism, or hypotonic fluid administration) that is most appropriately corrected by alternative therapies. 21. Is currently pregnant or breastfeeding. 22. Has any medical condition that, in the opinion of the investigator, could interfere with evaluation of the trial objectives or safety of the subjects. 23. Is deemed unsu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate that tolvaptan effectively maintains an increased level of serum sodium in children and adolescent subjects with euvolemic or hypervolemic hyponatremia. ;Secondary Objective: The main secondary objective is to evaluate safety of tolvaptan in children and adolescent subjects with euvolemic or hypervolemic hyponatremia. ;Primary end point(s): Primary Efficacy Outcome Variable: The primary efficacy outcome is the average daily area under the curve (AUC) of change from baseline in serum sodium level up to Day 4 within the double-blind treatment period. ;Timepoint(s) of evaluation of this end point: At Day 4 within the double-blind treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Outcome Variables: • Average daily AUC of changes from baseline at each visit in serum sodium level up to Day 30 within the double-blind treatment period. • Change from baseline in serum sodium concentration at Day 4 • Change from baseline in serum sodium concentration at Day 30 • Percentage of subjects who require rescue therapy or fluid restriction at any time during the double-blind treatment period Safety Outcome Variables: • Liver function test changes from baseline • Clinically significant changes in vital signs • Incidence of dehydration AEs • Change in Tanner stage from baseline to Day 30 • Percentage of subjects with overly rapid correction in serum sodium (=12 mmol/L in 24 hours) ;Timepoint(s) of evaluation of this end point: For Efficacy Outcome Variables: - At the end of each visit up to Day 30 within the double-blind treatment period - At the end of Day 4 - At the end of Day 30 - At any time during the double-blind treatment period For Safety Outcome Variables: - Up to Day 30 | — |
Countries
Germany, Italy, United Kingdom
Contacts
Public ContactDorothee Oberdhan
Otsuka Pharmaceutical Development & Commercialization, Inc.
Outcome results
None listed