Clinical Trials Logo

Clinical Trial Summary

The objective of this trial was to provide 6 months of safety follow-up for children and adolescents with dilutional (euvolemic or hypervolemic) hyponatremia who had previously participated in a tolvaptan hyponatremia trial and to assess the efficacy of tolvaptan in increasing serum sodium for those participants who received optional continuing tolvaptan treatment of variable duration (up to 6 months).


Clinical Trial Description

Core Safety Follow-up Component

• For all participants: To evaluate the post-treatment safety follow-up of children and adolescent participants with dilutional (euvolemic or hypervolemic) hyponatremia who have previously participated in a tolvaptan hyponatremia trial.

Optional Tolvaptan Treatment Component

• For participants who receive optional tolvaptan treatment: To demonstrate that tolvaptan safely and effectively achieves and maintains increased serum sodium concentrations in children and adolescent participants with dilutional (euvolemic or hypervolemic) hyponatremia when used for both multiple short-term treatments, and/or longer chronic treatments. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02020278
Study type Interventional
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact
Status Terminated
Phase Phase 3
Start date April 22, 2016
Completion date October 23, 2017

See also
  Status Clinical Trial Phase
Recruiting NCT06037928 - Plasma Sodium and Sodium Administration in the ICU
Recruiting NCT04561531 - Efficacy and Safety of Bolus Comparing With Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia. N/A
Terminated NCT02012959 - Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia Phase 3
Recruiting NCT02936167 - Comparison of Ringer Lactate and Isotonic Acetate Solution as Perioperative Maintenance Fluid for Children N/A
Completed NCT00621348 - Maintenance Intravenous Fluids in Children Phase 3
Terminated NCT03703713 - Colloid Osmotic Pressure and Osmolality in Hyponatremia
Completed NCT02926989 - Intravenous Fluids in Hospitalised Children Phase 4
Terminated NCT02959411 - Tolvaptan for Advanced or Refractory Heart Failure Phase 4
Completed NCT02573077 - An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
Withdrawn NCT02667977 - Reexamining Hypotonic Intravenous Fluid Use N/A
Terminated NCT01708811 - Hyponatremia and Myometrium Contractility. An Invitro Study N/A
Completed NCT01456533 - Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients N/A
Withdrawn NCT01326429 - Frequency and Origin of Dysnatremias in the Emergency Department N/A
Terminated NCT01227512 - Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia Phase 3
Recruiting NCT06013800 - Hyponatremia Volume Status Analysis by Point-of-care Ultrasound
Terminated NCT04020926 - Impact of Hyponatremia on Muscle Strength, Gait and Cognitive Function
Withdrawn NCT02442674 - A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia Phase 3
Completed NCT02545101 - An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH N/A
Terminated NCT02215148 - Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients N/A
Recruiting NCT01748331 - The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia N/A