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)
Overview
- Phase
- Phase 3
- Intervention
- Tolvaptan Oral Tablet
- Conditions
- Syndrome of Inappropriate Antidiuretic Hormone Secretion
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Enrollment
- 16
- Primary Endpoint
- Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Tolvaptan
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.
Intervention: Tolvaptan Oral Tablet
Outcomes
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(Day2, Day3, Day4, Day5, Day7, Day14, Day21 and the day after final IMP administration)