Oral Tolvaptan in patients with Euvolemic or Hypervolemic Hyponatremia
Research type
Research Study
Full title
A Phase 3b, Multicenter, Open-label, Randomized Withdrawal Trial of the Effects of Titrated Oral SAMSCA® (Tolvaptan) on Serum Sodium, Pharmacokinetics, and Safety in Children and Adolescent Subjects Hospitalized With Euvolemic or Hypervolemic Hyponatremia
IRAS ID
166694
Contact name
Detlef Bockenhauer
Contact email
Sponsor organisation
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eudract number
2013-002005-59
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Hyponatraemia is a disease seen in all age groups, hospitalised children in particular are at risk, and across a wide range of patients. It is characterised by a subnormal concentration of sodium in the blood and is manifest by a range of neurological symptoms which, left untreated, can be life threatening. Hyponatraemia is associated with significant additional hospital morbidity and cost.
In the adult population, hyponatraemia occurs in 15% to 20% of hospitalised patients. A similar situation exists for children, in whom approximately 25% of hospitalised children are found to have mild hyponatraemia and approximately 1% were found to have moderate hyponatraemia.
The study drug, Tolvaptan, is an experimental medicine which means it has not yet been approved by a drug approval agency for use in children and adolescents. This study is designed to determine whether Tolvaptan can effectively and safely increase and maintain sodium concentrations in children and adolescent participants with dilutional hyponatraemia.
This is an open-label, randomised study, where participants will be treated with oral Tolvaptan for up to 5 days, during which they will be randomised to withdraw from treatment early or late. About 100 participants aged 4 weeks to 18 years will be in the study across North America, Canada, and Europe, and they will be in the study for up to 21 days.REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/1608
Date of REC Opinion
22 Dec 2015
REC opinion
Further Information Favourable Opinion