At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 57 enrolled
Drug / intervention
Tolvaptan +1 moredrug
Likely dose
Tolvaptan 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 Pilot, Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Effects of Titrated Oral Tolvaptan 15, 30, or 60 mg QD on Cognitive and Neurological Function in Elderly Hyponatremic Patients
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Oct 29, 2007·Updated Apr 28, 2011
In Brief
A Phase 3 clinical trial evaluating Tolvaptan and Placebo for Hyponatremia. Completed, enrolled 57 participants across 12 sites.
Detailed Summary
Demonstrate an improvement in the composite scores of validated neurocognitive tests in elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyponatremia
CountriesUnited States
CollaboratorsOtsuka Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedOct 2007
Primary CompletionFeb 2009
Study CompletionMar 2009
TodayJul 2026
First PostedOct 29, 2007
Enrollment StartAug 1, 2007
Primary CompletionFeb 1, 2009
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.7 years ago
Interventions
Tolvaptandrug
15-60 mg oral tablet given once a day for 21 days.
Placebodrug
Placebo tablet given once daily for 21 days