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A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH

NCT03048747 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-11-02

Study results available
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Summary

The objective of this study is to investigate the efficacy and safety of tolvaptan based on the change in serum sodium concentration following administration of tolvaptan oral tablets at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.

Conditions

  • Syndrome of Inappropriate Antidiuretic Hormone Secretion

Interventions

DRUG

Tolvaptan Oral Tablet

Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-02
Primary Completion
2019-03-19
Completion
2019-03-19

Countries

  • Japan

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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 NCT03048747 on ClinicalTrials.gov