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

NCT02012959 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-09-26

Study results available
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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.

Conditions

Interventions

DRUG

Tolvaptan

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Global Clinical Development · Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-22
Primary Completion
2017-07-24
Completion
2017-07-24

Countries

  • United States
  • Italy
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02012959 on ClinicalTrials.gov