At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 111 enrolled
Drug / intervention
Tolvaptandrug
Likely dose
Not stated in 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.
International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia: Extension to Studies 156-02-235 and 156-03-238 to Assess One-year Safety
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted May 20, 2015·Updated Jan 21, 2016
In Brief
A Phase 3 clinical trial evaluating Tolvaptan for Hyponatremia. Completed, enrolled 111 participants.
Detailed Summary
This study will assess the safety of long-term tolvaptan use in patients previously enrolled in shorter-term Phase 3 studies and gather information on the natural history of hyponatremia in the context of tolvaptan therapy and underlying disease states.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyponatremia
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2004
Primary CompletionOct 2009
First PostedMay 2015
TodayJul 2026
First PostedMay 20, 2015
Enrollment StartMay 1, 2004
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 11.1 years ago
Interventions
Tolvaptandrug
Once Daily