At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 13 enrolled
Drug / intervention
OPC-41061drug
Likely dose
OPC-41061 15 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 Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
In Brief
A Phase 3 clinical trial evaluating OPC-41061 for Autosomal Dominant Polycystic Kidney Disease. Completed, enrolled 13 participants across 1 site.
Detailed Summary
ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral administration of OPC-41061 at doses of 15 mg twice daily (morning and evening). Administration will be continued until the time of manufacturing and distribution approval of OPC-41061 for ADPKD in Japan.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2009
First PostedDec 2009
Primary CompletionJul 2014
TodayJul 2026
First PostedDec 1, 2009
Enrollment StartNov 1, 2009
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 16.6 years ago
Interventions
OPC-41061drug
Repeated oral administration at doses of 15 mg twice daily (morning and evening)