At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 91 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 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan Followed by a Two Year Open-label Extension in Children and Adolescent Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Nov 16, 2016·Updated Jan 3, 2023
In Brief
A Phase 3 clinical trial evaluating Tolvaptan and Tolvaptan Matching-placebo for Autosomal Dominant Polycystic Kidney Disease (ADPKD). Completed, enrolled 91 participants across 20 sites in 4 countries.
Detailed Summary
The primary objective of the study is to assess the long term safety of treatment with tolvaptan in children and adolescents with autosomal dominant polycystic kidney disease (ADPKD). The secondary objective is to assess the pharmacodynamics, pharmacokinetics, and efficacy of tolvaptan in the same participant population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Germany, Italy, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartSep 2016
First PostedNov 2016
Primary CompletionNov 2021
TodayJul 2026
First PostedNov 16, 2016
Enrollment StartSep 23, 2016
Primary CompletionNov 17, 2021
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 9.6 years ago
Interventions
Tolvaptandrug
Tolvaptan spray-dried, immediate release tablets
Tolvaptan Matching-placebodrug
Tolvaptan matching-placebo tablets