At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 17 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) [Extension of Study 156-04-001]
In Brief
A Phase 2 clinical trial evaluating OPC-41061 for Autosomal Dominant Polycystic Kidney Disease. Completed, enrolled 17 participants across 1 site.
Detailed Summary
Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2006
First PostedFeb 2009
Primary CompletionNov 2010
TodayJul 2026
First PostedFeb 11, 2009
Enrollment StartApr 1, 2006
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 17.4 years ago
Interventions
OPC-41061drug
orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.