At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,803 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.
A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney Disease
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Sep 29, 2014·Updated Nov 27, 2019
In Brief
A Phase 3 clinical trial evaluating Tolvaptan for Polycystic Kidney, Autosomal Dominant. Completed, enrolled 1,803 participants across 210 sites in 20 countries.
Detailed Summary
The purpose of the trial was to evaluate and describe the long term safety of tolvaptan in participants with autosomal dominant polycystic kidney disease (ADPKD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Kidney, Autosomal Dominant
CountriesArgentina, Australia, Belgium, Canada, Czechia, Denmark, Germany, Hungary, Israel, Italy, Netherlands, Norway, Poland, Romania, Russia, South Africa, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartOct 2014
Primary CompletionNov 2018
TodayJul 2026
First PostedSep 29, 2014
Enrollment StartOct 17, 2014
Primary CompletionNov 9, 2018
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 11.8 years ago
Interventions
Tolvaptandrug
Tolvaptan tablets (15 or 30 mg) self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later