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

Phase 3

Completed

• Conditions: Syndrome of Inappropriate Antidiuretic Hormone Secretion
• Interventions: Drug: Tolvaptan Oral Tablet

• Registration Number: NCT03048747
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Study Start: 2017-03-02
• Primary Completion: 2019-03-19
• Study Completion: 2019-03-19
• Results First Submitted: 2020-09-08
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-08
• Last Update Submitted: 2020-10-08
• Results First Posted: 2020-11-02
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tolvaptan	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration	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 Outcome Measures

Name	Time	Method
Change in Serum Sodium Concentration	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