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

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.

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Key information

Conditions

Syndrome of Inappropriate Antidiuretic Hormone Secretion Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hypothalamic Diseases Inappropriate ADH Syndrome Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pituitary Diseases Water-Electrolyte Imbalance

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chubu Region, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects with a definite diagnosis of SIADH in reference to "Diagnostic and Treatment Manual of the Hypersecretion of Vasopressin (SIADH), Revised in 2011"
Subjects who have been on fluid restriction for at least 7 consecutive days at the time of informed consent and who are showing no improvement of hyponatremia at the time of the screening examination

Exclusion criteria

Subjects who have transient hyponatremia induced by drug administration
Subjects who are unable to sense thirst or who have difficulty with fluid intake
Subjects with urinary tract obstruction
Subjects who have participated in any other clinical trial within 30 days prior to informed consent
Subjects with serum sodium concentration of <120 mEq/L associated with neurologic impairment, including apathy, confusion, or seizures

Treatment and study plan

Tolvaptan Oral Tablet

Drug

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.

Primary outcomes

Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration

Time frame: Baseline, Day2, Day3, Day4, Day5, Day7, Day14, Day21, Day after final study medication

The percentage of subjects with normalized serum sodium concentration, defined as ≥135 mEq/L, on the day after final IMP administration will be calculated versus the number of subjects with serum sodium concentration of <135 mEq/L at baseline on Day 1 of the treatment period.

Secondary outcomes

Change in Serum Sodium Concentration

Time frame: Day2, Day3, Day4, Day5, Day7, Day14, Day21 and the day after final IMP administration

The mean and standard error of measured values for serum sodium concentration on the day of fixing the maintenance dose and on the day after final IMP administration were calculated.

The day of fixing the maintenance dose: Day2, Day3, Day4, Day5, Day7, Day14, and Day21

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Uncontrolled, Open-label, Dose-titration Trial to Investigate the Efficacy and Safety of Tolvaptan Tablets in Patients With Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Feb 9, 2017
Registry last updated: Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed