Effects and Safety of Oral Tolvaptan in Children with Low Blood Sodium
Research type
Research Study
Full title
A Pilot Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety, Efficacy, and Pharmacokinetics of Titrated Oral SAMSCA® (Tolvaptan) in Children and Adolescent Subjects With Euvolemic or Hypervolemic Hyponatremia
IRAS ID
181561
Contact name
Alessandro Giardini
Contact email
Sponsor organisation
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eudract number
2014-001582-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 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.\nIn 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. \nThe 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.\nThis is a double-blind study, where participants will be given either Tolvaptan, or Placebo, for 30 days. 8 participants, aged 4 weeks to 18 years, will be in the study within Europe, and their participation will take up to 45 days.
REC name
London - South East Research Ethics Committee
REC reference
15/LO/2193
Date of REC Opinion
27 Jan 2016
REC opinion
Unfavourable Opinion