At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 178 enrolled
Drug / intervention
Tolvaptan MR +2 moredrug
Likely dose
Tolvaptan MR 80 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 Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Placebo-masked, Parallel-group Pilot Trial to Compare the Efficacy, Tolerability, and Safety of Tolvaptan Modified-release and Immediate-release Formulations in Subjects With Autosomal Dominant Polycystic Kidney Disease
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Oct 14, 2011·Updated Sep 27, 2018
In Brief
A Phase 2 clinical trial evaluating Tolvaptan MR, Tolvaptan IR, and 1 other intervention for Autosomal Dominant Polycystic Kidney Disease. Completed, enrolled 178 participants across 35 sites.
Detailed Summary
The purpose of this study is to compare the short-term effects of two tolvaptan formulations in patients with ADPKD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2011
First PostedOct 2011
Primary CompletionJul 2013
TodayJul 2026
First PostedOct 14, 2011
Enrollment StartOct 1, 2011
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.7 years ago
Interventions
Tolvaptan MRdrug
50/80 mg capsules
Tolvaptan IRdrug
60/30 mg capsules
Placebodrug
tablet