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

Phase 3

Terminated

• Conditions: Hyponatremia
• Interventions: Drug: Tolvaptan

• Registration Number: NCT02012959
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

The purpose of this trial was to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent participants with euvolemic or hypervolemic hyponatremia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-17
• Study Start: 2015-09-22
• Primary Completion: 2017-07-24
• Study Completion: 2017-07-24
• Status Verified: 2018-07
• Results First Submitted: 2018-07-31
• Results First Submitted QC: 2018-07-31
• Results First Posted: 2018-08-28
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tolvaptan Early Withdrawal	Tolvaptan	All participants initially received tolvaptan once daily for the first 2 days. A third day of treatment was permitted if a participant had not reached the desired sodium target improvement per the investigator's judgment. At the end of Day 2 (or Day 3), responders (participants who achieved an increase in serum sodium by ≥4 millimoles/liter \[mmol/L\]) were randomized to either the Early or Late Withdrawal Group. Non-responders could continue treatment with tolvaptan for an additional 2 days. Discontinued tolvaptan treatment immediately after randomization. All participants were observed up to 14 days post randomization.
Tolvaptan Late Withdrawal	Tolvaptan	All participants initially received tolvaptan once daily for the first 2 days. A third day of treatment was permitted if a participant had not reached the desired sodium target improvement per the investigator's judgment. At the end of Day 2 (or Day 3), responders (participants who achieved an increase in serum sodium by ≥4 mmol/L) were randomized to either the Early or Late Withdrawal Group in Treatment Phase B. Non-responders could continue treatment with tolvaptan for an additional 2 days. Continued treatment for 2 additional days. All participants were observed up to 14 days post randomization.

Primary Outcome Measures

Name	Time	Method
Change In Serum Sodium Concentration For Responders	Day 2/2a, Day 4	Change in serum sodium concentration (mEq/L) for responders from Day 2 (or Day 2a) at the end of Treatment Phase A (where all participants received tolvaptan) to the end of Treatment Phase B for the Early compared to Late Withdrawal groups is reported. Once a participant was randomized to Treatment Phase B, any additional therapies for the purpose of raising serum sodium, including fluid restriction, were considered rescue therapy. Upon receipt of rescue therapy, a participant's endpoint data was collected and then censored from the efficacy analysis thereafter, unless specified.

Secondary Outcome Measures

Name	Time	Method
Change In Serum Sodium Concentration During Treatment Phase A	Baseline, Day 2/2a	Change in serum sodium concentration (mEq/L) from baseline to the end of Day 2 (or 2a) during Treatment Phase A for all participants (responders and non-responders) is reported.
Fluid Balance (Intake Minus Output) During Treatment Phase A	Every 6 hours on Days 1 and 2	Every 6 hours and for the 24-hour daily interval on Days 1 and 2 during Treatment Phase A, fluid balance (milliliters \[mL\]) was determined by fluid intake (oral and intravenous) minus urine output. Improved fluid balance would be indicated through the induction of increased urine volume. Fluid balance was monitored per institutional guidelines.