CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 135 enrolled
Drug / intervention
tolvaptandrug
Likely dose
tolvaptan 45mgfrom 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.

Search/NCT01280721
NCT01280721Phase 3Completed
CompareCT.gov

A Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Jan 21, 2011·Updated Jan 17, 2019

In Brief

A Phase 3 clinical trial evaluating tolvaptan for Autosomal Dominant Polycystic Kidney Disease （ADPKD). Completed, enrolled 135 participants across 7 sites.

Detailed Summary

ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutosomal Dominant Polycystic Kidney Disease （ADPKD)
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 21, 2011
Enrollment StartNov 1, 2010
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.4 years ago

Interventions

tolvaptandrug

Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.