At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 16 enrolled
Drug / intervention
Tolvaptan Oral Tabletdrug
Likely dose
Tolvaptan Oral Tablet 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Tolvaptan Oral Tablet for Syndrome of Inappropriate Antidiuretic Hormone Secretion. Completed, enrolled 16 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 2017
Enrollment StartMar 2017
Primary CompletionMar 2019
TodayJul 2026
First PostedFeb 9, 2017
Enrollment StartMar 2, 2017
Primary CompletionMar 19, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.4 years ago
Interventions
Tolvaptan Oral Tabletdrug
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.