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

Trial Profile

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Jul 2017

At a glance

  • Drugs Tolvaptan (Primary)
  • Indications Hyponatraemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 14 Jul 2017 This trial has been discontinued Germany (end date: 2017-06-22)
    • 22 Nov 2016 Planned End Date changed from 1 Aug 2016 to 1 Aug 2017.
    • 22 Nov 2016 Planned primary completion date changed from 1 Aug 2016 to 1 Aug 2017.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top