Clinical Trial: Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official 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 Subj

Brief Summary: The purpose of this trial is to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent subjects with euvolemic or hypervolemic hyponatremia.

Detailed Summary:
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Current Primary Outcome: Change in serum sodium concentration. [ Time Frame: Day 2/2a/3, Day 4/5 ]

Change in serum sodium concentration.


Original Primary Outcome: Change in serum sodium concentration. [ Time Frame: Day 2/3, Day 4/5 ]

Change in serum sodium concentration.


Current Secondary Outcome:

  • Change in serum sodium concentration. [ Time Frame: Day 2/2a/3 ]
    Change in serum sodium concentration at the end of Day 2/3 from baseline in Phase A.
  • Overly rapid increase in serum sodium. [ Time Frame: 24 hours ]
    Percentage of subjects with overly rapid increase in serum sodium (≥12 mEq/L in 24 hours after 1st dose).
  • Change in serum sodium from 24 hours post-last dose to 7 days post-last dose. [ Time Frame: 7 Days ]
    Change in serum sodium from 24 hours post-last dose to 7 days post-last dose.
  • Percentage of subjects requiring rescue medication. [ Time Frame: Days 4/5 ]
    Percentage of subjects requiring rescue medication during Phase A and Phase B of the trial.
  • Neurological examinations. [ Time Frame: 7 days ]
  • Vital Signs of Potential Clinical Relevance - Mean Change from Baseline to study completion. [ Time Frame: 7 days ]
    Vital Signs of Potential Clinical Relevance - Mean Change from Baseline to study completion.
  • Body Weight of Potential Clinical Relevance - Mean Change from Baseline to study completion. [ Time Frame: 7 days ]
    Body Weight of Potential Clinical Relevance - Mean Change from Baseline to study completion.
  • Blood Pressure of Potential Clinical Relevance - Mean Change from Baseline to study completion. [ Time Frame: 7 days ]
    Blood Pressure of Potential Clinical Relevance - Mean Change from Baseline to study completion.
  • Clinical Laboratory Tests of Potential Clinical Relevance - Mean Change from Baseline to study completion. [ Time Frame: 7 days ]
    Clinical Laboratory Tests of Potential Clinical Relevance - Mean Change from Baseline to study completion.
  • Fluid intake. [ Time Frame: Day 1/2 ]
    Fluid intake every 6 hours on Days 1 and 2 (Phase A).
  • Fluid Restriction [ Time Frame: Day 1/2 ]
    Percentage of subjects requiring fluid restriction during Treatment Phase A and Treatment Phase B.


Original Secondary Outcome:

  • Change in serum sodium concentration. [ Time Frame: Day 2/3 ]
    Change in serum sodium concentration at the end of Day 2/3 from baseline in Phase A.
  • Overly rapid increase in serum sodium. [ Time Frame: 24 hours ]
    Percentage of subjects with overly rapid increase in serum sodium (≥12 mmol/L in 24 hours after 1st dose).
  • Percentage of subjects requiring rescue medication. [ Time Frame: Days 4/5 ]
    Percentage of subjects requiring rescue medication during Phase A and Phase B of the trial.


Information By: Otsuka Pharmaceutical Development & Commercialization, Inc.

Dates:
Date Received: December 11, 2013
Date Started: November 2014
Date Completion: May 2017
Last Updated: November 17, 2016
Last Verified: November 2016