At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,083 enrolled
Drug / intervention
Tolvaptandrug
Likely dose
Tolvaptan 30 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.
Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Oct 5, 2010·Updated Oct 25, 2021
In Brief
A Phase 3 clinical trial evaluating Tolvaptan for Autosomal Dominant Polycystic Kidney Disease (ADPKD). Completed, enrolled 1,083 participants across 97 sites in 13 countries.
Detailed Summary
To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Romania, Russia, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2010
First PostedOct 2010
Primary CompletionFeb 2016
TodayJul 2026
First PostedOct 5, 2010
Enrollment StartMay 26, 2010
Primary CompletionFeb 29, 2016
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 15.7 years ago
Interventions
Tolvaptandrug
Tablets of 15 or 30 mg