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A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia

NCT02442674 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-07-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tolvaptan

Tolvaptan 3.75-, 7.5-, 15-, and 30-mg Tablets. Dosage: Depending on age, weight and serum sodium response: Tablet (3.75 mg - 60 mg daily) Frequency: Once daily Duration: 30 (+2) days

OTHER

Placebo

Placebo tablet matching active drug

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Ann Dandurand, MD · Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-06-22
Completion
2017-06-22

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Entities

Diseases

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 NCT02442674 on ClinicalTrials.gov