Clinical Trial: An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Subjects With Euvolemic or Hypervolemic Hyponatremia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 3b, Multicenter, Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Subjects With Euvolemic or Hypervolemic Hyponatremia Who Hav
Brief Summary: The objective of this trial is to provide 6 months of safety follow-up for children and adolescents with dilutional (euvolemic or hypervolemic) hyponatremia who have previously participated in a tolvaptan hyponatremia trial, and to assess the efficacy of tolvaptan in increasing serum sodium for those subjects who receive optional continuing tolvaptan treatment of variable duration (up to 6 months).
Detailed Summary:
Core Safety Follow-up Component • For all subjects: To evaluate the post-treatment safety follow-up of children and adolescent subjects with dilutional (euvolemic or hypervolemic) hyponatremia who have previously participated in a tolvaptan hyponatremia trial.
Optional Tolvaptan Treatment Component
• For subjects who receive optional tolvaptan treatment: To demonstrate that tolvaptan safely and effectively achieves and maintains increased serum sodium concentrations in children and adolescent subjects with dilutional (euvolemic or hypervolemic) hyponatremia when used for both multiple short-term treatments, and/or longer chronic treatments.
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Current Primary Outcome: Change from baseline in serum sodium while tolvaptan is being administered [ Time Frame: Up to 6 months ]
Original Primary Outcome:
- Adverse Events, including cases of dehydration. [ Time Frame: Minimum 6 months ]Percent of Patients reporting Adverse Events.
- Vital signs of potential clinical relevance - Mean change from baseline to study completion. [ Time Frame: Minimum 6 months ]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: Minimum 6 months ]Body weight of potential clinical relevance - Mean change from baseline to study completion.
- Height of potential clinical relevance - Mean change from baseline to study completion. [ Time Frame: Minimum 6 months ]Height of potential clinical relevance - Mean change from baseline to study completion.
- Growth percentiles of potential clinical relevance - Mean change from baseline to study completion. [ Time Frame: Minimum 6 months ]Growth percentiles of potential clinical relevance - Mean change from baseline to study completion.
- Tanner stages of potential clinical relevance - Mean change from baseline to study completion. [ Time Frame: Minimum 6 months ]Tanner stages of potential clinical relevance - Mean change from baseline to study completion.
Current Secondary Outcome:
- Percentage of subjects who require rescue therapy while on tolvaptan treatment [ Time Frame: Up to 6 months ]
- Percentage of subjects who have recurrence of hyponatremia while on tolvaptan [ Time Frame: Up to 6 months ]
- Percentage of subjects requiring continuation of tolvaptan following 30 days of treatment [ Time Frame: Up to 6 months ]
- Change from baseline in QoL assessments (monthly for subjects on tolvaptan [ Time Frame: Up to 6 months ]
- Percentage of subjects with overly rapid correction in serum sodium(≥ 12 mEq/L [mmol/L]) in 24 hours after the first dose at introduction or reintroduction of tolvaptan [ Time Frame: Up to 6 months ]
- Changes from baseline in ALT, AST, BT, and creatinine for subjects on tolvaptan [ Time Frame: Up to 6 months ]
- Frequency of AE reports (including cases of dehydration) [ Time Frame: Up to 6 months ]
- Changes from baseline in growth percentiles by visit for body height and weight [ Time Frame: Up to 6 months ]
- Tanner Staging progression score [ Time Frame: Up to 6 months ]
- Plasma concentrations of tolvaptan and metabolites in subjects who have continued tolvaptan therapy for 8 consecutive weeks [ Time Frame: Greater than or equal to 8 weeks ]
Original Secondary Outcome:
- Change in serum sodium from baseline at each visit while IMP is being administered. [ Time Frame: Minimum 6 months ]
- Plasma concentrations of tolvaptan and metabolites in subjects who have continued tolvaptan therapy for 8 consecutive weeks. [ Time Frame: 8 weeks. ]Plasma concentrations of tolvaptan and metabolites in subjects who have continued tolvaptan therapy for 8 consecutive weeks.
Information By: Otsuka Pharmaceutical Development & Commercialization, Inc.
Dates:
Date Received: December 18, 2013
Date Started: April 2016
Date Completion: May 2020
Last Updated: April 24, 2017
Last Verified: April 2017