At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,445 enrolled
Drug / intervention
Tolvaptan +1 moredrug
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.
A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jan 30, 2007·Updated Jul 2, 2017
In Brief
A Phase 3 clinical trial evaluating Tolvaptan and Placebo for Polycystic Kidney Disease, Autosomal Dominant. Completed, enrolled 1,445 participants across 133 sites in 15 countries.
Detailed Summary
This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Poland, Romania, Russia, United Kingdom, United States
CollaboratorsOtsuka Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedJan 2007
Primary CompletionJan 2012
TodayJul 2026
First PostedJan 30, 2007
Enrollment StartJan 1, 2007
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 19.4 years ago
Interventions
Tolvaptandrug
Tolvaptan was supplied as tablets.
Placebodrug
Placebo was supplied as tablets.